Difference between revisions of "Multiple myeloma"

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(added Carfilzomib regimen)
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''Are you looking for a regimen but can't find it here? It is possible that we've moved it to the [[Multiple_myeloma_-_historical|historical regimens page]]. For placebo or observational studies in this condition, please visit [[Multiple myeloma - null regimens|this page]]. If you still can't find it, please let us know so we can add it!''<br>
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<br>'''Note: due to its size/complexity, the multiple myeloma page has been split into sub-pages:'''
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*[[Multiple_myeloma,_induction|Induction (transplant eligible and ineligible)]]
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*[[Multiple_myeloma,_consolidation_and_maintenance|First-line consolidation and maintenance]]
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*[[Multiple_myeloma,_relapsed-refractory|Relapsed/refractory, including subsequent consolidation and maintenance]]
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*[[Smoldering multiple myeloma]]
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'''This page will remain as a consolidated location for guidelines and prognostic information.
  
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Is there a regimen missing from this list?  Would you like to share a different dosage/schedule or an additional reference for a regimen?  Have you noticed an error?  Do you have an idea that will help the site grow to better meet your needs and the needs of many others?  You are [[How_to_contribute|invited to contribute to the site]].
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*''We have moved [[How I Treat]] articles to a dedicated page.''
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{{TOC limit|limit=3}}
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<section begin=guidelines />
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=Guidelines=
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'''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.'''
  
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{{TOC limit|limit=2}}
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==[https://www.asco.org ASCO]/CCO==
 +
*'''2019:''' Mikhael et al. [https://doi.org/10.1200/jco.18.02096 Treatment of Multiple Myeloma: ASCO and CCO Joint Clinical Practice Guideline] [https://pubmed.ncbi.nlm.nih.gov/30932732/ PubMed]
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*'''2018:''' Anderson et al. [https://doi.org/10.1200/JCO.2017.76.6402 Role of bone-modifying agents in multiple myeloma: American Society of Clinical Oncology Clinical Practice Guideline update] [https://pubmed.ncbi.nlm.nih.gov/29341831/ PubMed]
 +
**'''2007:''' Kyle et al. [https://doi.org/10.1200/jco.2007.12.1269 American Society of Clinical Oncology 2007 clinical practice guideline update on the role of bisphosphonates in multiple myeloma] [https://pubmed.ncbi.nlm.nih.gov/17515569/ PubMed]
 +
**'''2002:''' Berenson et al. [https://doi.org/10.1200/jco.2002.06.037 American Society of Clinical Oncology clinical practice guidelines: the role of bisphosphonates in multiple myeloma] [https://pubmed.ncbi.nlm.nih.gov/12202673/ PubMed]
  
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==BiRD==
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==[http://www.b-s-h.org.uk/ BSH]/[http://www.ukmf.org.uk/ UKMF]==
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BiRD: '''<u>Bi</u>'''axin, '''<u>R</u>'''evlimid, '''<u>D</u>'''examethasone
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*'''2017:''' [https://doi.org/10.1111/bjh.14827 Guidelines for the use of imaging in the management of patients with myeloma] [https://pubmed.ncbi.nlm.nih.gov/28677897/ PubMed]
 +
*'''2017:''' [https://doi.org/10.1111/bjh.14514 Guidelines for screening and management of late and long-term consequences of myeloma and its treatment] [https://pubmed.ncbi.nlm.nih.gov/28107574/ PubMed]
 +
*'''2014:''' [http://www.ukmf.org.uk/wp-content/uploads/2014/10/Updates-to-the-guidelines-Oct-2014.pdf Updates to the guidelines for the diagnosis and management of multiple myeloma] [https://pubmed.ncbi.nlm.nih.gov/24801672/ PubMed]
 +
**'''2011:''' [https://doi.org/10.1111/bjh.12926 Guidelines for the diagnosis and management of multiple myeloma 2011] [https://pubmed.ncbi.nlm.nih.gov/24801672/ PubMed]
  
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===Regimen===
+
==[http://myeloma-europe.org.linux9.curanetserver.dk/index.php European Myeloma Network (EMN)]==
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*[[Clarithromycin (Biaxin)]] 500 mg PO BID on days 2-28 of cycle 1; 500 mg PO BID on days 1-28 of cycle 2 and thereafter
+
*'''2020:''' Ludwig et al. [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7787974/ Recommendations for vaccination in multiple myeloma: a consensus of the European Myeloma Network] [https://pubmed.ncbi.nlm.nih.gov/32814840/ PubMed]
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*[[Lenalidomide (Revlimid)]] 25 mg PO on days 3-21 of cycle 1; 25 mg PO on days 1-21 of cycle 2 and thereafter
+
*'''2018:''' Caers et al. [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6278986/ European Myeloma Network recommendations on tools for the diagnosis and monitoring of multiple myeloma: what to use and when] [https://pubmed.ncbi.nlm.nih.gov/30171031/ PubMed]
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*[[Dexamethasone (Decadron)]] 40 mg PO on days 1, 2, 3, 8, 15, 22 of cycle 1; 40 mg PO on days 1, 8, 15, 22 of cycle 2 and thereafter
+
*'''2018:''' Gay et al. [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5792264/ From transplant to novel cellular therapies in multiple myeloma: European Myeloma Network guidelines and future perspectives] [https://pubmed.ncbi.nlm.nih.gov/29217780/ PubMed]
  
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'''28-week cycles'''
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==EHA/[https://www.esmo.org/ ESMO]==
 +
*'''2021:''' Dimopoulos et al. [https://doi.org/10.1016/j.annonc.2020.11.014 Multiple myeloma: EHA-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/33549387/ PubMed]
 +
**'''2017:''' Moreau et al. [https://doi.org/10.1093/annonc/mdx096 Multiple myeloma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/23956208/ PubMed]
 +
**'''2013:''' Moreau et al. [https://doi.org/10.1093/annonc/mdt297 Multiple myeloma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/23956208/ PubMed]
 +
**'''2010:''' Harousseau & Dreyling. [https://doi.org/10.1093/annonc/mdq178 Multiple myeloma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/20555068/ PubMed]
 +
**'''2009:''' Harousseau & Dreyling. [https://doi.org/10.1093/annonc/mdp140 Multiple myeloma: ESMO clinical recommendations for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/19454476/ PubMed]
 +
**'''2008:''' Harousseau & Dreyling. [https://doi.org/10.1093/annonc/mdn088 Multiple myeloma: ESMO clinical recommendations for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/18456769/ PubMed]
 +
**'''2007:''' Harousseau. [https://doi.org/10.1093/annonc/mdm032 Multiple myeloma: ESMO clinical recommendations for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/17491042/ PubMed]
 +
**'''2005:''' Harousseau et al. [https://doi.org/10.1093/annonc/mdi818 ESMO Minimum Clinical Recommendations for diagnosis, treatment and follow-up of multiple myeloma] [https://pubmed.ncbi.nlm.nih.gov/15888750/ PubMed]
  
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Supportive medications:
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==[http://imwg.myeloma.org/ IMWG]==
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*Aspirin 81 mg PO daily
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*'''2021:''' Moreau et al. [https://doi.org/10.1016/S1470-2045(20)30756-7 Treatment of relapsed and refractory multiple myeloma: recommendations from the International Myeloma Working Group] [https://pubmed.ncbi.nlm.nih.gov/33662288 PubMed]
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*Omeprazole (Prilosed) 20 mg PO daily
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*'''2021:''' Terpos et al. [https://doi.org/10.1016/S1470-2045(20)30559-3 Treatment of multiple myeloma-related bone disease: recommendations from the Bone Working Group of the International Myeloma Working Group] [https://pubmed.ncbi.nlm.nih.gov/33545067/ PubMed]
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*[[Trimethoprim/Sulfamethoxazole (Bactrim DS)]] PO BID 3 times a week
 
  
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===References===
+
*'''2016:''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4920674/ Treatment of multiple myeloma with high-risk cytogenetics: a consensus of the International Myeloma Working Group] [https://pubmed.ncbi.nlm.nih.gov/27002115 PubMed]
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# Niesvizky R, Jayabalan DS, Christos PJ, Furst JR, Naib T, Ely S, Jalbrzikowski J, Pearse RN, Zafar F, Pekle K, Larow A, Lent R, Mark T, Cho HJ, Shore T, Tepler J, Harpel J, Schuster MW, Mathew S, Leonard JP, Mazumdar M, Chen-Kiang S, Coleman M. BiRD (Biaxin [clarithromycin]/Revlimid [lenalidomide]/dexamethasone) combination therapy results in high complete- and overall-response rates in treatment-naive symptomatic multiple myeloma. Blood. 2008 Feb 1;111(3):1101-9. Epub 2007 Nov 7. [http://bloodjournal.hematologylibrary.org/content/111/3/1101.long link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17989313 PubMed]
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*'''2016:''' [https://doi.org/10.1200/JCO.2015.65.0044 International Myeloma Working Group recommendations for the diagnosis and management of myeloma-related renal impairment] [https://pubmed.ncbi.nlm.nih.gov/26976420/ PubMed]
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*'''2014:''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3918540/ International Myeloma Working Group consensus statement for the management, treatment, and supportive care of patients with myeloma not eligible for standard autologous stem-cell transplantation] [https://pubmed.ncbi.nlm.nih.gov/24419113/ PubMed]
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==Bortezomib (Velcade)==
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*'''2013:''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4878084/ International Myeloma Working Group recommendations for the treatment of multiple myeloma-related bone disease] [https://pubmed.ncbi.nlm.nih.gov/23690408/ PubMed]
−
===Regimen===
 
−
*[[Bortezomib (Velcade)]] 1.3 mg/m2 IV on days 1, 4, 8, 11
 
−
 
 
−
'''21-day cycles x 8 cycles, THEN'''
 
−
 
 
−
*[[Bortezomib (Velcade)]] 1.3 mg/m2 IV on days 1, 8, 15, 22
 
−
 
 
−
'''35-day cycles x 3 cycles'''
 
−
 
 
−
Supportive medications (mentioned in Richardson, et al. 2005):
 
−
*Bisphosphonate IV therapy every 3-4 weeks unless contraindicated
 
−
 
 
−
===References===
 
−
# Richardson PG, Barlogie B, Berenson J, Singhal S, Jagannath S, Irwin D, Rajkumar SV, Srkalovic G, Alsina M, Alexanian R, Siegel D, Orlowski RZ, Kuter D, Limentani SA, Lee S, Hideshima T, Esseltine DL, Kauffman M, Adams J, Schenkein DP, Anderson KC. A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med. 2003 Jun 26;348(26):2609-17. [http://www.nejm.org/doi/full/10.1056/NEJMoa030288 link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/12826635 PubMed]
 
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# Richardson PG, Sonneveld P, Schuster MW, Irwin D, Stadtmauer EA, Facon T, Harousseau JL, Ben-Yehuda D, Lonial S, Goldschmidt H, Reece D, San-Miguel JF, Bladé J, Boccadoro M, Cavenagh J, Dalton WS, Boral AL, Esseltine DL, Porter JB, Schenkein D, Anderson KC; Assessment of Proteasome Inhibition for Extending Remissions (APEX) Investigators. Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. N Engl J Med. 2005 Jun 16;352(24):2487-98. [http://www.nejm.org/doi/full/10.1056/NEJMoa043445 link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/15958804 PubMed]
 
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# Richardson PG, Sonneveld P, Schuster M, Irwin D, Stadtmauer E, Facon T, Harousseau JL, Ben-Yehuda D, Lonial S, Goldschmidt H, Reece D, Miguel JS, Bladé J, Boccadoro M, Cavenagh J, Alsina M, Rajkumar SV, Lacy M, Jakubowiak A, Dalton W, Boral A, Esseltine DL, Schenkein D, Anderson KC. Extended follow-up of a phase 3 trial in relapsed multiple myeloma: final time-to-event results of the APEX trial. Blood. 2007 Nov 15;110(10):3557-60. Epub 2007 Aug 9. [http://bloodjournal.hematologylibrary.org/content/110/10/3557.long link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17690257 PubMed]
 
−
 
 
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==Bortezomib (Velcade) & Dexamethasone (Decadron)==
 
−
===Regimen===
 
−
*[[Bortezomib (Velcade)]] 1.3 mg/m2 IV on days 1, 4, 8, 11
 
−
*[[Dexamethasone (Decadron)]] 40 mg PO days 1-4, 9-12 of cycles 1 & 2; 40 mg PO days 1-4 of cycles 3 & 4
 
−
 
 
−
'''21-day cycles x 4 cycles'''
 
−
 
 
−
Supportive medications:
 
−
*Pamidronate 90 mg or [[Zoledronic acid (Zometa)]] 4 mg IV every 28 days until first transplant
 
−
*"Antibiotics, antifungal agents, and antiviral prophylaxis in accordance with local practice."
 
−
 
 
−
===Weekly bortezomib regimen (Fukushima, et al. 2011)===
 
−
*[[Bortezomib (Velcade)]] 1.3 mg/m2 IV on days 1, 8, 15, 22
 
−
*[[Dexamethasone (Decadron)]] 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23
 
−
 
 
−
'''35-day cycles, to be continued until complete response, progression of disease, or severe adverse events'''
 
−
 
 
−
===References===
 
−
# Harousseau JL, Attal M, Avet-Loiseau H, Marit G, Caillot D, Mohty M, Lenain P, Hulin C, Facon T, Casassus P, Michallet M, Maisonneuve H, Benboubker L, Maloisel F, Petillon MO, Webb I, Mathiot C, Moreau P. Bortezomib plus dexamethasone is superior to vincristine plus doxorubicin plus dexamethasone as induction treatment prior to autologous stem-cell transplantation in newly diagnosed multiple myeloma: results of the IFM 2005-01 phase III trial. J Clin Oncol. 2010 Oct 20;28(30):4621-9. Epub 2010 Sep 7. [http://jco.ascopubs.org/content/28/30/4621.long link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/20823406 PubMed]
 
−
# Avet-Loiseau H, Leleu X, Roussel M, Moreau P, Guerin-Charbonnel C, Caillot D, Marit G, Benboubker L, Voillat L, Mathiot C, Kolb B, Macro M, Campion L, Wetterwald M, Stoppa AM, Hulin C, Facon T, Attal M, Minvielle S, Harousseau JL. Bortezomib plus dexamethasone induction improves outcome of patients with t(4;14) myeloma but not outcome of patients with del(17p). J Clin Oncol. 2010 Oct 20;28(30):4630-4. Epub 2010 Jul 19. [http://jco.ascopubs.org/content/28/30/4630.long link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/20644101 PubMed]
 
−
# Fukushima T, Nakamura T, Iwao H, Nakajima A, Miki M, Sato T, Sakai T, Sawaki T, Fujita Y, Tanaka M, Masaki Y, Nakajima H, Motoo Y, Umehara H. Efficacy and safety of bortezomib plus dexamethasone therapy for refractory or relapsed multiple myeloma: once-weekly administration of bortezomib may reduce the incidence of gastrointestinal adverse events. Anticancer Res. 2011 Jun;31(6):2297-302. [http://ar.iiarjournals.org/content/31/6/2297.long link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/21737655 PubMed]
 
−
 
 
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==Bortezomib (Velcade), Thalidomide (Thalomid), Dexamethasone (Decadron)==
 
−
===Regimen===
 
−
*[[Bortezomib (Velcade)]] 1.3 mg/m2 IV on days 1, 4, 8, 11
 
−
*[[Thalidomide (Thalomid)]] 100 mg PO on days 1-14 of cycle 1; 200 mg PO on days 15-21 of cycle 1; 200 mg PO on days 1-21 of cycles 2 & 3
 
−
*[[Dexamethasone (Decadron)]] 40 mg PO days 1-4, 9-12
 
−
 
 
−
'''21-day cycles x 3 cycles'''
 
−
 
 
−
===Alternate regimen (Kaufman, et al. 2010)===
 
−
*[[Bortezomib (Velcade)]] 1.3 mg/m2 IV on days 1, 4, 8, 11
 
−
*[[Thalidomide (Thalomid)]] 100 mg PO on days 1-21
 
−
*[[Dexamethasone (Decadron)]] 40 mg PO days 1-4, 9-12
 
−
 
 
−
'''21-day cycles x 3-4 cycles'''
 
−
 
 
−
Supportive medications:
 
−
*Aspirin prophylaxis to decrease risk of DVTs
 
−
*Prophylactic "treatment with antiviral and antibiotic medications"
 
−
 
 
−
===References===
 
−
# Kaufman JL, Nooka A, Vrana M, Gleason C, Heffner LT, Lonial S. Bortezomib, thalidomide, and dexamethasone as induction therapy for patients with symptomatic multiple myeloma: a retrospective study. Cancer. 2010 Jul 1;116(13):3143-51. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.25143/full link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/20564642 PubMed]
 
−
# Cavo M, Tacchetti P, Patriarca F, Petrucci MT, Pantani L, Galli M, Di Raimondo F, Crippa C, Zamagni E, Palumbo A, Offidani M, Corradini P, Narni F, Spadano A, Pescosta N, Deliliers GL, Ledda A, Cellini C, Caravita T, Tosi P, Baccarani M; GIMEMA Italian Myeloma Network. Bortezomib with thalidomide plus dexamethasone compared with thalidomide plus dexamethasone as induction therapy before, and consolidation therapy after, double autologous stem-cell transplantation in newly diagnosed multiple myeloma: a randomised phase 3 study. Lancet. 2010 Dec 18;376(9758):2075-85. Epub 2010 Dec 9. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2961424-9/fulltext link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/21146205 PubMed]
 
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==Bortezomib (Velcade) & Doxorubicin liposomal (Doxil)==
 
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===Regimen===
 
−
*[[Bortezomib (Velcade)]] 1.3 mg/m2 IV bolus on days 1, 4, 8, 11
 
−
*[[Doxorubicin liposomal (Doxil)]] 30 mg/m2 IV over at least 1 hour on day 4 (given after bortezomib)
 
−
 
−
'''21-day cycles, given until progression of disease or unacceptable toxicity'''
 
−
 
 
−
===References===
 
−
# Orlowski RZ, Nagler A, Sonneveld P, Bladé J, Hajek R, Spencer A, San Miguel J, Robak T, Dmoszynska A, Horvath N, Spicka I, Sutherland HJ, Suvorov AN, Zhuang SH, Parekh T, Xiu L, Yuan Z, Rackoff W, Harousseau JL. Randomized phase III study of pegylated liposomal doxorubicin plus bortezomib compared with bortezomib alone in relapsed or refractory multiple myeloma: combination therapy improves time to progression. J Clin Oncol. 2007 Sep 1;25(25):3892-901. Epub 2007 Aug 6. [http://jco.ascopubs.org/content/25/25/3892.long link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17679727 PubMed]
 
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−
==Carfilzomib (Kyprolis)==
 
−
===Regimen===
 
−
*[[Carfilzomib (Kyprolis)]] 20 mg/m2 (body surface area capped at 2.2 m2) IV over 2-10 minutes on days 1-2, 8-9, 15-16 of cycle 1; then on subsequent cycles, [[Carfilzomib (Kyprolis)]] 27 mg/m2 (body surface area capped at 2.2 m2) IV over 2-10 minutes on days 1-2, 8-9, 15-16
 
−
 
 
−
'''28-week cycles x up to 12 cycles, given until progression of disease or unacceptable toxicity'''
 
−
 
 
−
Supportive medications:
 
−
*[[Dexamethasone (Decadron)]] 4 mg PO/IV before all doses in cycles 1-2; restart dexamethasone premedication if patients experience infusion reactions: "fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina."
 
−
 
 
−
===References===
 
−
# D. S. D. Siegel, T. Martin, M. Wang, R. Vij, S. Lonial, V. Kukreti, N. J. Bahlis, M. Alsina, G. Somlo, F. Buadi, F. J. Reu, K. W. Song, L. A. Kunkel, A. Wong, M. Vallone, R. Z. Orlowski, A. K. Stewart, S. Singhal, S. Jagannath, A. J. Jakubowiak, The Multiple Myeloma Research Consortium (MMRC). PX-171-003-A1, an open-label, single-arm, phase (Ph) II study of carfilzomib (CFZ) in patients (pts) with relapsed and refractory multiple myeloma (R/R MM): Long-term follow-up and subgroup analysis. 2011 ASCO Annual Meeting abstract 8027. [http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=81812 link to abstract]
 
−
# Vij R, Wang M, Kaufman JL, Lonial S, Jakubowiak AJ, Stewart AK, Kukreti V, Jagannath S, McDonagh KT, Alsina M, Bahlis NJ, Reu FJ, Gabrail NY, Belch A, Matous JV, Lee P, Rosen P, Sebag M, Vesole DH, Kunkel LA, Wear SM, Wong AF, Orlowski RZ, Siegel DS. An open-label, single-arm, phase 2 (PX-171-004) study of single-agent carfilzomib in bortezomib-naive patients with relapsed and/or refractory multiple myeloma. Blood. 2012 Jun 14;119(24):5661-70. Epub 2012 May 3. [http://bloodjournal.hematologylibrary.org/content/119/24/5661.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/22555973 PubMed]
 
−
# [http://kyprolis.com/Content/pdf/PrescribingInformation.pdf Carfilzomib (Kyprolis) package insert]
 
−
 
 
−
==CyBorD==
 
−
CyBorD: '''<u>Cy</u>'''clophosphamide, '''<u>Bor</u>'''tezomib, '''<u>D</u>'''examethasone
 
−
===Regimen===
 
−
*[[Cyclophosphamide (Cytoxan)]] 300 mg/m2 PO on days 1, 8, 15, 22
 
−
*[[Bortezomib (Velcade)]] 1.3 mg/m2 IV on days 1, 4, 8, 11
 
−
*[[Dexamethasone (Decadron)]] 40 mg PO on days 1-4, 9-12, 17-20
 
−
 
 
−
'''28-day cycles x 4-12 cycles'''
 
−
 
 
−
Supportive medications:
 
−
*Proton pump inhibitor (PPI)
 
−
*Acyclovir
 
−
*Quinolone antibiotic
 
−
*Antifungal mouthwash recommended
 
−
 
 
−
===References===
 
−
# Reeder CB, Reece DE, Kukreti V, Chen C, Trudel S, Hentz J, Noble B, Pirooz NA, Spong JE, Piza JG, Zepeda VH, Mikhael JR, Leis JF, Bergsagel PL, Fonseca R, Stewart AK. Cyclophosphamide, bortezomib and dexamethasone induction for newly diagnosed multiple myeloma: high response rates in a phase II clinical trial. Leukemia. 2009 Jul;23(7):1337-41. Epub 2009 Feb 19. [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2711213/?tool=pubmed link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/19225538 PubMed]
 
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# Khan ML, Reeder CB, Kumar SK, Lacy MQ, Reece DE, Dispenzieri A, Gertz MA, Greipp P, Hayman S, Zeldenhurst S, Dingli D, Lust J, Russell S, Laumann KM, Mikhael JR, Leif Bergsagel P, Fonseca R, Vincent Rajkumar S, Keith Stewart A. A comparison of lenalidomide/dexamethasone versus cyclophosphamide/lenalidomide/dexamethasone versus cyclophosphamide/bortezomib/dexamethasone in newly diagnosed multiple myeloma. Br J Haematol. 2012 Feb;156(3):326-33. doi: 10.1111/j.1365-2141.2011.08949.x. Epub 2011 Nov 23. [http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2011.08949.x/abstract link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/22107129 PubMed]
 
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−
==DCEP==
 
−
DCEP: '''<u>D</u>'''examethasone, '''<u>C</u>'''yclophosphamide, '''<u>E</u>'''toposide, '''<u>P</u>'''latinol
 
−
 
 
−
===Regimen===
 
−
*[[Dexamethasone (Decadron)]] 40 mg PO on days 1-4
 
−
*[[Cyclophosphamide (Cytoxan)]] 400 mg/m2/day IV continuous infusion on days 1-4
 
−
*[[Etoposide (Vepesid)]] 40 mg/m2/day IV continuous infusion on days 1-4
 
−
*[[Cisplatin (Platinol)]] 15 mg/m2/day IV continuous infusion on days 1-4
 
−
 
 
−
'''28-day cycles x 2 cycles'''
 
−
 
 
−
Supportive medications:
 
−
*Pamidronate 90 mg or [[Zoledronic acid (Zometa)]] 4 mg IV every 28 days until first transplant
 
−
*"Antibiotics, antifungal agents, and antiviral prophylaxis in accordance with local practice."
 
−
 
 
−
===References===
 
−
# Harousseau JL, Attal M, Avet-Loiseau H, Marit G, Caillot D, Mohty M, Lenain P, Hulin C, Facon T, Casassus P, Michallet M, Maisonneuve H, Benboubker L, Maloisel F, Petillon MO, Webb I, Mathiot C, Moreau P. Bortezomib plus dexamethasone is superior to vincristine plus doxorubicin plus dexamethasone as induction treatment prior to autologous stem-cell transplantation in newly diagnosed multiple myeloma: results of the IFM 2005-01 phase III trial. J Clin Oncol. 2010 Oct 20;28(30):4621-9. Epub 2010 Sep 7. [http://jco.ascopubs.org/content/28/30/4621.long link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/20823406 PubMed]
 
−
 
 
−
==Dexamethasone (Decadron)==
 
−
===Regimen===
 
−
*[[Dexamethasone (Decadron)]] 40 mg PO on days 1-4, 9-12, 17-20 for cycles 1-2; 40 mg PO on days 1-4 of cycles 3-12
 
−
 
 
−
'''6-week cycles x 12 cycles'''
 
−
 
 
−
===References===
 
−
# Facon T, Mary JY, Pégourie B, Attal M, Renaud M, Sadoun A, Voillat L, Dorvaux V, Hulin C, Lepeu G, Harousseau JL, Eschard JP, Ferrant A, Blanc M, Maloisel F, Orfeuvre H, Rossi JF, Azaïs I, Monconduit M, Collet P, Anglaret B, Yakoub-Agha I, Wetterwald M, Eghbali H, Vekemans MC, Maisonneuve H, Troncy J, Grosbois B, Doyen C, Thyss A, Jaubert J, Casassus P, Thielemans B, Bataille R; Intergroupe Francophone du Myélome (IFM) group. Dexamethasone-based regimens versus melphalan-prednisone for elderly multiple myeloma patients ineligible for high-dose therapy. Blood. 2006 Feb 15;107(4):1292-8. Epub 2005 Sep 20. [http://bloodjournal.hematologylibrary.org/content/107/4/1292.long link to original paper] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/16174762 PubMed]
 
−
 
 
−
==DVD==
 
−
DVD: '''<u>D</u>'''oxil, '''<u>V</u>'''incristine, '''<u>D</u>'''examethasone
 
−
 
 
−
===Regimen===
 
−
*[[Doxorubicin liposomal (Doxil)]] 40 mg/m2 IV day 1
 
−
*[[Vincristine (Oncovin)]] 2 mg IV day 1
 
−
*[[Dexamethasone (Decadron)]] 40 mg PO/IV days 1-4
 
−
 
 
−
'''4-week cycles x 6-8 cycles'''
 
−
 
 
−
Supportive medications:
 
−
*Vitamin B6 200 mg PO daily to help reduce risk of palmar-plantar erythrodysesthesia (PPE)
 
−
 
 
−
===References===
 
−
# Hussein MA, Wood L, Hsi E, Srkalovic G, Karam M, Elson P, Bukowski RM. A Phase II trial of pegylated liposomal doxorubicin, vincristine, and reduced-dose dexamethasone combination therapy in newly diagnosed multiple myeloma patients. Cancer. 2002 Nov 15;95(10):2160-8. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.10946/full link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/12412170 PubMed]
 
−
 
 
−
==Melphalan (Alkeran) & Prednisone (Sterapred)==
 
−
===Regimen===
 
−
*[[Melphalan (Alkeran)]] 0.15 mg/kg PO on days 1-7
 
−
*[[Prednisone (Sterapred)]] 20 mg PO TID on days 1-7
 
−
 
 
−
'''6-week cycles'''
 
−
 
 
−
===Alternate regimen #1 (San Miguel, et al. 2008)===
 
−
*[[Melphalan (Alkeran)]] 0.25 mg/kg PO on days 1-4
 
−
*[[Prednisone (Sterapred)]] 2 mg/kg PO on days 1-4
 
−
 
 
−
'''6-week cycles x 12 cycles'''
 
−
 
 
−
===Alternate regimen #2 (Facon, et al. 2006)===
 
−
*[[Melphalan (Alkeran)]] 9 mg/m2 PO on days 1-4
 
−
*[[Prednisone (Sterapred)]] 60 mg/m2 PO on days 1-4
 
−
 
 
−
'''6-week cycles x 9 cycles'''
 
−
 
 
−
===References===
 
−
# Kyle RA. Monoclonal gammopathy and multiple myeloma in the elderly. Baillieres Clin Haematol. 1987 Jun;1(2):533-57. [http://www.ncbi.nlm.nih.gov/pubmed/3322448 PubMed]
 
−
# Facon T, Mary JY, Pégourie B, Attal M, Renaud M, Sadoun A, Voillat L, Dorvaux V, Hulin C, Lepeu G, Harousseau JL, Eschard JP, Ferrant A, Blanc M, Maloisel F, Orfeuvre H, Rossi JF, Azaïs I, Monconduit M, Collet P, Anglaret B, Yakoub-Agha I, Wetterwald M, Eghbali H, Vekemans MC, Maisonneuve H, Troncy J, Grosbois B, Doyen C, Thyss A, Jaubert J, Casassus P, Thielemans B, Bataille R; Intergroupe Francophone du Myélome (IFM) group. Dexamethasone-based regimens versus melphalan-prednisone for elderly multiple myeloma patients ineligible for high-dose therapy. Blood. 2006 Feb 15;107(4):1292-8. Epub 2005 Sep 20. [http://bloodjournal.hematologylibrary.org/content/107/4/1292.long link to original paper] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/16174762 PubMed]
 
−
# San Miguel JF, Schlag R, Khuageva NK, Dimopoulos MA, Shpilberg O, Kropff M, Spicka I, Petrucci MT, Palumbo A, Samoilova OS, Dmoszynska A, Abdulkadyrov KM, Schots R, Jiang B, Mateos MV, Anderson KC, Esseltine DL, Liu K, Cakana A, van de Velde H, Richardson PG; VISTA Trial Investigators. Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. N Engl J Med. 2008 Aug 28;359(9):906-17. [http://www.nejm.org/doi/full/10.1056/NEJMoa0801479 link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/18753647 PubMed]
 
−
 
 
−
==MPL==
 
−
MPL: '''<u>M</u>'''elphalan, '''<u>P</u>'''rednisone, '''<u>L</u>'''enalidomide
 
−
 
 
−
===Regimen===
 
−
*[[Melphalan (Alkeran)]] 0.18 mg/kg PO on days 1-4
 
−
*[[Prednisone (Sterapred)]] 2 mg/kg PO on days 1-4
 
−
*[[Lenalidomide (Revlimid)]] 10 mg PO on days 1-21
 
−
 
 
−
'''28-day cycles x 9 cycles, THEN'''
 
−
 
 
−
*[[Lenalidomide (Revlimid)]] 10 mg PO on days 1-21
 
−
 
 
−
'''28-day cycles, to continue until relapsed or refractory disease'''
 
−
 
 
−
Supportive medications:
 
−
*Ciprofloxacin (Cipro) 500 mg PO BID
 
−
*Aspirin 100 mg PO daily
 
−
 
 
−
===References===
 
−
# Palumbo A, Falco P, Corradini P, Falcone A, Di Raimondo F, Giuliani N, Crippa C, Ciccone G, Omedè P, Ambrosini MT, Gay F, Bringhen S, Musto P, Foà R, Knight R, Zeldis JB, Boccadoro M, Petrucci MT; GIMEMA--Italian Multiple Myeloma Network. Melphalan, prednisone, and lenalidomide treatment for newly diagnosed myeloma: a report from the GIMEMA--Italian Multiple Myeloma Network. J Clin Oncol. 2007 Oct 1;25(28):4459-65. Epub 2007 Sep 4. [http://jco.ascopubs.org/content/25/28/4459.long link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17785703 PubMed]
 
−
 
 
−
==MPT==
 
−
MPT: '''<u>M</u>'''elphalan, '''<u>P</u>'''rednisone, '''<u>T</u>'''halidomide
 
−
 
 
−
===Regimen===
 
−
*[[Melphalan (Alkeran)]] 0.25 mg/kg PO on days 1-4
 
−
*[[Prednisone (Sterapred)]] 2 mg/kg PO on days 1-4
 
−
*[[Thalidomide (Thalomid)]] 200 mg PO, increased as tolerated after 2-4 weeks on therapy to maximal dose of 400 mg, given on days 1-42
 
−
 
 
−
'''42-day cycles x 12 cycles'''
 
−
 
 
−
===Alternate regimen (Palumbo, et al. 2006; Palumbo, et al. 2008)===
 
−
*[[Melphalan (Alkeran)]] 4 mg/m2 PO on days 1-7
 
−
*[[Prednisone (Sterapred)]] 40 mg/m2 PO on days 1-7
 
−
*[[Thalidomide (Thalomid)]] 100 mg PO on days 1-28
 
−
*[[Enoxaparin (Lovenox)]] 40 mg SC on days 1-28 of cycles 1-4
 
−
 
 
−
'''28-day cycles x 6 cycles, THEN'''
 
−
 
 
−
*[[Thalidomide (Thalomid)]] 100 mg PO daily until evidence of relapse or refractory disease
 
−
 
 
−
===References===
 
−
# Palumbo A, Bringhen S, Caravita T, Merla E, Capparella V, Callea V, Cangialosi C, Grasso M, Rossini F, Galli M, Catalano L, Zamagni E, Petrucci MT, De Stefano V, Ceccarelli M, Ambrosini MT, Avonto I, Falco P, Ciccone G, Liberati AM, Musto P, Boccadoro M; Italian Multiple Myeloma Network, GIMEMA. Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial. Lancet. 2006 Mar 11;367(9513):825-31. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2806%2968338-4/fulltext link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/16530576 PubMed]
 
−
# Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, Renaud M, Harousseau JL, Guillerm G, Chaleteix C, Dib M, Voillat L, Maisonneuve H, Troncy J, Dorvaux V, Monconduit M, Martin C, Casassus P, Jaubert J, Jardel H, Doyen C, Kolb B, Anglaret B, Grosbois B, Yakoub-Agha I, Mathiot C, Avet-Loiseau H; Intergroupe Francophone du Myélome. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007 Oct 6;370(9594):1209-18. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2807%2961537-2/fulltext link to original article] '''contains prot ocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17920916 PubMed]
 
−
# Palumbo A, Bringhen S, Liberati AM, Caravita T, Falcone A, Callea V, Montanaro M, Ria R, Capaldi A, Zambello R, Benevolo G, Derudas D, Dore F, Cavallo F, Gay F, Falco P, Ciccone G, Musto P, Cavo M, Boccadoro M. Oral melphalan, prednisone, and thalidomide in elderly patients with multiple myeloma: updated results of a randomized controlled trial. Blood. 2008 Oct 15;112(8):3107-14. Epub 2008 May 27. [http://bloodjournal.hematologylibrary.org/content/112/8/3107.long link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/18505783 PubMed]
 
−
 
 
−
==PAD==
 
−
PAD: '''<u>P</u>'''S-341, '''<u>A</u>'''driamycin, '''<u>D</u>'''examethasone
 
−
 
 
−
===Regimen===
 
−
*[[Bortezomib (Velcade)]] 1.3 mg/m2 IV bolus on days 1, 4, 8, 11
 
−
*[[Doxorubicin (Adriamycin)]] 4.5-9 mg/m2 IV on days 1-4
 
−
*[[Dexamethasone (Decadron)]] 40 mg PO days 1-4, 8-11, 15-18 of cycle 1; 40 mg PO days 1-4 of cycles 2-4
 
−
 
 
−
'''21-day cycles x 4 cycles'''
 
−
 
 
−
===References===
 
−
# Oakervee HE, Popat R, Curry N, Smith P, Morris C, Drake M, Agrawal S, Stec J, Schenkein D, Esseltine DL, Cavenagh JD. PAD combination therapy (PS-341/bortezomib, doxorubicin and dexamethasone) for previously untreated patients with multiple myeloma. Br J Haematol. 2005 Jun;129(6):755-62. [http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2005.05519.x/full link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/15953001 PubMed]
 
−
 
 
−
==RD==
 
−
RD: '''<u>R</u>'''evlimid, '''<u>D</u>'''examethasone
 
  
−
===Regimen (low-dose dexamethasone)===
+
==NCCN==
−
*[[Lenalidomide (Revlimid)]] 25 mg PO days 1-21
+
*[https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1445 NCCN Guidelines - Multiple Myeloma]
−
*[[Dexamethasone (Decadron)]] 40 mg PO days 1, 8, 15, 22
+
*'''2020:''' Kumar et al. [https://doi.org/10.6004/Jnccn.2020.0057 Multiple Myeloma, Version 3.2021, NCCN Clinical Practice Guidelines in Oncology.] [https://pubmed.ncbi.nlm.nih.gov/33285522/ PubMed]
 +
*'''2017:''' Kumar et al. [https://doi.org/10.6004/jnccn.2017.0023 Multiple Myeloma, Version 3.2017, NCCN Clinical Practice Guidelines in Oncology] [https://pubmed.ncbi.nlm.nih.gov/28188192/ PubMed]
 +
*'''2016:''' Anderson et al. [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6016087/ NCCN Guidelines Insights: Multiple Myeloma, Version 3.2016] [https://pubmed.ncbi.nlm.nih.gov/27059188/ PubMed]
 +
*'''2015:''' Anderson et al. [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc4891187/ Multiple Myeloma, Version 2.2016: Clinical Practice Guidelines in Oncology] [https://pubmed.ncbi.nlm.nih.gov/26553768/ PubMed]
 +
*'''2011:''' Anderson et al. [https://doi.org/10.6004/Jnccn.2011.0095 Multiple myeloma.] [https://pubmed.ncbi.nlm.nih.gov/21975914/ PubMed]
 +
*'''2009:''' Anderson et al. [https://doi.org/10.6004/Jnccn.2009.0061 NCCN clinical practice guidelines in oncology: multiple myeloma.] [https://pubmed.ncbi.nlm.nih.gov/19878637/ PubMed]
 +
*'''2007:''' Anderson et al. [https://doi.org/10.6004/Jnccn.2007.0014 Multiple myeloma. Clinical practice guidelines in oncology.] [https://pubmed.ncbi.nlm.nih.gov/17335683/ PubMed]
 +
*'''2004:''' Anderson et al. [https://doi.org/10.6004/Jnccn.2004.0029 Multiple myeloma clinical practice guidelines in oncoloqy.] [https://pubmed.ncbi.nlm.nih.gov/19795598/ PubMed]
  
−
'''28-day cycles'''
+
==SITC==
 +
*'''2020:''' Shah et al. [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7359060/ The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of multiple myeloma] [https://pubmed.ncbi.nlm.nih.gov/32661116/ PubMed]
 +
<section end=guidelines />
 +
<section begin=bottom />
  
−
===Alternate regimen #1 (Rajkumar, et al. 2010)===
+
=Response criteria=
−
*[[Lenalidomide (Revlimid)]] 25 mg PO days 1-21
+
*[https://doi.org/10.1038/sj.leu.2404284 IMWG international uniform response criteria for multiple myeloma. (Durie et al. Leukemia 2006)] [https://pubmed.ncbi.nlm.nih.gov/16855634/ PubMed]
−
*[[Dexamethasone (Decadron)]] 40 mg PO days 1-4, 9-12, 17-20
+
**[https://doi.org/10.1038/sj.leu.2404284 Make note of these errors] which remain in the online version of the IMWG criteria as of 7/7/2013.
 +
**[https://doi.org/10.1038/leu.2015.290 Clarification of the definition of complete response in multiple myeloma (Leukemia 2015)] [https://pubmed.ncbi.nlm.nih.gov/26487274/ PubMed]
 +
*[https://doi.org/10.1046/j.1365-2141.1998.00930.x European Blood and Marrow Transplant (EBMT) criteria. (Bladé et al. Br J Hematol 1998)] [https://pubmed.ncbi.nlm.nih.gov/9753033/ PubMed]
  
−
'''28-day cycles'''
+
=Prognosis=
  
−
Supportive medications:
+
==[http://myeloma.org/pdfs/Durie-SalmonSS.pdf Durie-Salmon Staging System] - 1975==
−
*EITHER pamidronate 90 mg IV over 2-4 hours every 28 days
 
−
*OR [[Zoledronic acid (Zometa)]] 4 mg IV over 15 minutes every 28 days
 
−
*"Thromboprophylaxis" aspirin (80 mg or 325 mg per physician discretion) once daily as thrombosis prophylaxis.
 
  
−
===Alternate regimen #2 (Rajkumar, et al. 2005; Dimopoulos, et al. 2007; Weber, et al. 2007)===
+
===Composed of four factors with a modifier based on renal function===
−
*[[Lenalidomide (Revlimid)]] 25 mg PO days 1-21
+
*Serum levels of monoclonal protein (only defined for IgM, IgA, and Bence-Jones)
−
*[[Dexamethasone (Decadron)]] 40 mg PO days 1-4, 9-12, 17-20 of cycles 1-4; 40 mg PO days 1-4 of cycle 5 and thereafter
+
*Number of lytic bone lesions
 +
*Hemoglobin
 +
*Serum calcium level
  
−
'''28-day cycles'''
+
===Risk stratification===
 +
*'''Stage I:''' (must meet ALL criteria)
 +
**Hemoglobin greater than 10 g/dL
 +
**Calcium normal or less than or equal to 12 mg/dL
 +
**Skeletal survey with normal bone structure (scale 0) or solitary bone plasmacytoma only
 +
**Monoclonal protein relatively small (IgG M-spike value less than 5 g/dL OR IgA M-spike value less than 3 g/dL OR urine light chain protein less than 4 g/24 hr)
 +
*'''Stage II:''' not stage I or stage III
 +
*'''Stage III: ''' (if meets ANY of the criteria)
 +
**Hemoglobin less than 8.5 g/dL
 +
**Calcium greater than 12 mg/dL
 +
**Skeletal survey with extensive skeletal destruction and major fractures
 +
**Monoclonal protein relatively large (IgG M-spike value greater than 7 g/dL OR IgA M-spike value greater than 5 g/dL OR urine light chain protein greater than 12 g/24 hr)
  
−
Supportive medications (only listed in Rajkumar, et al. 2005):
+
===Modifier===
−
*Aspirin 80 mg or 325 mg depending on physician choice PO daily for thromboprophylaxis
+
*'''A:''' relatively normal creatinine (less than 2 mg/dL)
 +
*'''B:''' creatinine greater than or equal to 2 mg/dL
  
 
===References===
 
===References===
−
# Rajkumar SV, Hayman SR, Lacy MQ, Dispenzieri A, Geyer SM, Kabat B, Zeldenrust SR, Kumar S, Greipp PR, Fonseca R, Lust JA, Russell SJ, Kyle RA, Witzig TE, Gertz MA. Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma. Blood. 2005 Dec 15;106(13):4050-3. Epub 2005 Aug 23. [http://bloodjournal.hematologylibrary.org/content/106/13/4050.long link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/16118317 PubMed]
+
#Durie BG, Salmon SE. A clinical staging system for multiple myeloma. Correlation of measured myeloma cell mass with presenting clinical features, response to treatment, and survival. Cancer. 1975 Sep;36(3):842-54. [https://doi.org/10.1002/1097-0142(197509)36:3%3C842::AID-CNCR2820360303%3E3.0.CO;2-U link to original article] [https://pubmed.ncbi.nlm.nih.gov/1182674/ PubMed]
−
# Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foà R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. [http://www.nejm.org/doi/full/10.1056/NEJMoa070594 link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/18032762 PubMed]
 
−
# Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42. [http://www.nejm.org/doi/full/10.1056/NEJMoa070596 link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/18032763 PubMed]
 
−
# Rajkumar SV, Jacobus S, Callander NS, Fonseca R, Vesole DH, Williams ME, Abonour R, Siegel DS, Katz M, Greipp PR; Eastern Cooperative Oncology Group. Lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: an open-label randomised controlled trial. Lancet Oncol. 2010 Jan;11(1):29-37. Epub 2009 Oct 21. [http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3042271/?tool=pubmed link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/10233375 PubMed]
 
−
 
 
−
==RVD==
 
−
RVD: '''<u>R</u>'''evlimid, '''<u>V</u>'''elcade, '''<u>D</u>'''examethasone
 
−
 
 
−
===Regimen===
 
−
*[[Lenalidomide (Revlimid)]] 25 mg PO on days 1-14
 
−
*[[Bortezomib (Velcade)]] 1.3 mg/m2 IV on days 1, 4, 8, 11
 
−
*[[Dexamethasone (Decadron)]] 20 mg PO days 1, 2, 4, 5, 8, 9, 11, 12
 
−
 
 
−
'''21-day cycles x 4-8 cycles'''
 
  
−
Supportive medications:
+
==[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2627786/table/T3/ International Staging System (ISS)] - 2005==
−
*Aspirin 81 mg or 325 mg PO daily
 
−
*Antiviral therapy, such as Acyclovir (Zovirax) 400 mg PO daily
 
−
*Bisphosphonate
 
  
−
Patients who responded and tolerated therapy could proceed to maintenance therapy at previously tolerated dose with a different schedule:
+
===Composed of two factors===
−
*[[Lenalidomide (Revlimid)]] 25 mg (or previously tolerated dose) PO on days 1-14
+
*Serum albumin level
−
*[[Bortezomib (Velcade)]] 1.3 mg/m2 (or previously tolerated dose) IV on days 1 & 8
+
*Serum beta-2 microglobulin level
−
*[[Dexamethasone (Decadron)]] 20 mg (or previously tolerated dose) PO days 1, 2, 8, 9
 
  
−
'''21-day cycles'''
+
===Risk stratification===
 +
*'''Stage I:''' ''Median survival of 62 months''
 +
**Beta-2 microglobulin less than 3.5 mg/l
 +
**Albumin greater than or equal to 3.5 g/dl
 +
*'''Stage II:''' ''Median survival of 44 months''
 +
**Not meeting stage I or stage III criteria
 +
*'''Stage III: ''' ''Median survival of 29 months''
 +
**Beta-2 microglobulin greater than or equal to 5.5 mg/l
  
 
===References===
 
===References===
−
# Richardson PG, Weller E, Lonial S, Jakubowiak AJ, Jagannath S, Raje NS, Avigan DE, Xie W, Ghobrial IM, Schlossman RL, Mazumder A, Munshi NC, Vesole DH, Joyce R, Kaufman JL, Doss D, Warren DL, Lunde LE, Kaster S, Delaney C, Hideshima T, Mitsiades CS, Knight R, Esseltine DL, Anderson KC. Lenalidomide, bortezomib, and dexamethasone combination therapy in patients with newly diagnosed multiple myeloma. Blood. 2010 Aug 5;116(5):679-86. Epub 2010 Apr 12. [http://bloodjournal.hematologylibrary.org/content/116/5/679.long link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/20385792 PubMed]
+
# Greipp PR, San Miguel J, Durie BG, Crowley JJ, Barlogie B, Bladé J, Boccadoro M, Child JA, Avet-Loiseau H, Kyle RA, Lahuerta JJ, Ludwig H, Morgan G, Powles R, Shimizu K, Shustik C, Sonneveld P, Tosi P, Turesson I, Westin J. International staging system for multiple myeloma. J Clin Oncol. 2005 May 20;23(15):3412-20. Epub 2005 Apr 4. [https://doi.org/10.1200/jco.2005.04.242 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15809451/ PubMed]
 +
# Kyle RA, Rajkumar SV. Criteria for diagnosis, staging, risk stratification and response assessment of multiple myeloma. Leukemia. 2009 Jan;23(1):3-9. Epub 2008 Oct 30. [https://doi.org/10.1038/leu.2008.291 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2627786/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/18971951/ PubMed]
  
−
==TD==
+
==IMWG consensus on risk stratification - 2013==
−
TD: '''<u>T</u>'''halidomide, '''<u>D</u>'''examethasone
 
  
−
===Regimen===
+
===Composed of four factors===
−
*[[Thalidomide (Thalomid)]] 50 mg PO days 1-14 of cycle 1; 100 mg PO days 15-28 of cycle 1; 200 mg PO days 1-28 of cycle 2 and thereafter
+
*Serum albumin level
−
*[[Dexamethasone (Decadron)]] 40 mg PO days 1-4, 9-12, 17-20 during cycles 1-4; 40 mg PO days 1-4 of cycle 5 and thereafter
+
*Serum beta-2 microglobulin level
 +
*Age
 +
*Chromosomal abnormalities detected by interphase fluorescent in situ hybridization (FISH)
  
−
'''28-day cycles'''
+
===Risk stratification===
−
 
+
*'''Low risk:''' (must meet all criteria) ''Median survival of greater than 10 years''
−
===Alternate regimen (Rajkumar, et al. 2002, Rajkumar, et al. 2006)===
+
**[[#International_Staging_System_.28ISS.29_-_2005|ISS]] Stage I or II
−
*[[Thalidomide (Thalomid)]] 200 mg PO days 1-28
+
**Age less than 55 years
−
*[[Dexamethasone (Decadron)]] 40 mg PO days 1-4, 9-12, 17-20 on odd-numbered cycles; 40 mg PO days 1-4 of even-numbered cycles
+
**Absence of the following: del(17p13), t(4;14), +1q21
−
 
+
*'''Standard risk:''' ''Median survival of 7 years''
−
'''28-day cycles'''
+
**Not meeting low risk or high risk criteria
 +
*'''High risk: '''(if meets both criteria) ''Median survival of 2 years''
 +
**[[#International_Staging_System_.28ISS.29_-_2005|ISS]] Stage II or III
 +
**Either of the following: del(17p13) or t(4;14)
  
 
===References===
 
===References===
−
# Weber D, Rankin K, Gavino M, Delasalle K, Alexanian R. Thalidomide alone or with dexamethasone for previously untreated multiple myeloma. J Clin Oncol. 2003 Jan 1;21(1):16-9. [http://jco.ascopubs.org/content/21/1/16.full link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/12506164 PubMed]
+
# Chng WJ, Dispenzieri A, Chim CS, Fonseca R, Goldschmidt H, Lentzsch S, Munshi N, Palumbo A, San Miguel J, Sonneveld P, Cavo M, Usmani S, Durie BG, Avet-Loiseau H; International Myeloma Working Group. IMWG consensus on risk stratification in multiple myeloma. Leukemia. 2014 Feb;28(2):269-77. Epub 2013 Aug 26. [https://doi.org/10.1038/leu.2013.247 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23974982/ PubMed]
−
# Rajkumar SV, Hayman S, Gertz MA, Dispenzieri A, Lacy MQ, Greipp PR, Geyer S, Iturria N, Fonseca R, Lust JA, Kyle RA, Witzig TE. Combination therapy with thalidomide plus dexamethasone for newly diagnosed myeloma. J Clin Oncol. 2002 Nov 1;20(21):4319-23. [http://jco.ascopubs.org/content/20/21/4319.long link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/12409330 PubMed]
 
−
# Rajkumar SV, Blood E, Vesole D, Fonseca R, Greipp PR; Eastern Cooperative Oncology Group. Phase III clinical trial of thalidomide plus dexamethasone compared with dexamethasone alone in newly diagnosed multiple myeloma: a clinical trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2006 Jan 20;24(3):431-6. Epub 2005 Dec 19. [http://jco.ascopubs.org/content/24/3/431.long link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/16365178 PubMed]
 
−
# Rajkumar SV, Rosiñol L, Hussein M, Catalano J, Jedrzejczak W, Lucy L, Olesnyckyj M, Yu Z, Knight R, Zeldis JB, Bladé J. Multicenter, randomized, double-blind, placebo-controlled study of thalidomide plus dexamethasone compared with dexamethasone as initial therapy for newly diagnosed multiple myeloma. J Clin Oncol. 2008 May 1;26(13):2171-7. Epub 2008 Mar 24. [http://jco.ascopubs.org/content/26/13/2171.long link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/18362366 PubMed]
 
−
 
 
−
==VAD (Vincristine)==
 
−
VAD: '''<u>V</u>'''incristine, '''<u>A</u>'''driamycin, '''<u>D</u>'''examethasone
 
−
 
 
−
===Regimen===
 
−
*[[Vincristine (Oncovin)]] 0.4 mg IV over 30 minutes on days 1-4
 
−
*[[Doxorubicin (Adriamycin)]] 9 mg/m2 IV over 30 minutes on days 1-4
 
−
*[[Dexamethasone (Decadron)]] 40 mg PO on days 1-4, 9-12, 17-20 of odd-numbered cycles only
 
−
 
 
−
'''4-week cycles'''
 
−
 
 
−
Supportive medications (not listed consistently in references):
 
−
*Fluconazole (Diflucan) 200 mg PO daily
 
−
*Trimethoprim/Sulfamethoxazole 960 mg (paper did not specify which component was 960 mg) PO BID for "prophylaxis"
 
−
 
 
−
===Alternate regimen #1, with prednisone maintenance (Berenson, et al. 2002)===
 
−
*[[Vincristine (Oncovin)]] 0.4 mg/day IV continuous infusion on days 1-4
 
−
*[[Doxorubicin (Adriamycin)]] 9 mg/m2/day IV continuous infusion on days 1-4
 
−
*[[Dexamethasone (Decadron)]] 40 mg PO on days 1-4
 
−
*[[Prednisone (Sterapred)]] 50 mg PO on days 9, 11, 13, 15, 17, 19
 
  
−
'''21-day cycles x at least months until at least 25% regression of disease'''
+
==[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4846284/ Revised International Staging System (R-ISS)] - 2015==
  
−
Patients with at least 50% regression in 6 months or 25% regression in 9-12 months of therapy were then started on maintenance therapy:
+
===Composed of four factors===
−
*[[Prednisone (Sterapred)]] 50 mg PO every other day
+
*Serum albumin level
 +
*Serum beta-2 microglobulin level
 +
*Serum LDH
 +
*Chromosomal abnormalities detected by interphase fluorescent in situ hybridization (FISH)
  
−
===Alternate regimen #2 (Harousseau, et al. 2010)===
+
===Risk stratification===
−
*[[Vincristine (Oncovin)]] 0.4 mg/day IV continuous infusion on days 1-4
+
*'''Low risk:''' ''5-year overall survival = 82%''
−
*[[Doxorubicin (Adriamycin)]] 9 mg/m2/day IV continuous infusion on days 1-4
+
**Beta-2 microglobulin less than 3.5 mg/l
−
*[[Dexamethasone (Decadron)]] 40 mg PO on days 1-4, 9-12, 17-20 of cycles 1 & 2; 40 mg PO on days 1-4 of cycles 3 and thereafter
+
**Albumin less than or equal to 3.5 g/dl
−
 
+
**LDH less than the upper limit of normal range
−
'''28-day cycles'''
+
**Absence of the following: del(17p), t(4;14), t(14;16)
−
 
+
*'''Intermediate risk:''' ''5-year overall survival = 62%''
−
Supportive medications:
+
**Not meeting low risk or high risk criteria
−
*Pamidronate 90 mg or [[Zoledronic acid (Zometa)]] 4 mg IV every 28 days until first transplant
+
*'''High risk: '''(if meets ANY of the criteria) ''5-year overall survival = 40%''
−
*"Antibiotics, antifungal agents, and antiviral prophylaxis in accordance with local practice."
+
**Beta-2 microglobulin greater than or equal to 5.5 mg/l
 +
**LDH greater than the upper limit of normal range
 +
**Any of the following: del(17p), t(4;14), t(14;16)
  
 
===References===
 
===References===
−
# Segeren CM, Sonneveld P, van der Holt B, Baars JW, Biesma DH, Cornellissen JJ, Croockewit AJ, Dekker AW, Fibbe WE, Löwenberg B, van Marwijk Kooy M, van Oers MH, Richel DJ, Schouten HC, Vellenga E, Verhoef GE, Wijermans PW, Wittebol S, Lokhorst HM. Vincristine, doxorubicin and dexamethasone (VAD) administered as rapid intravenous infusion for first-line treatment in untreated multiple myeloma. Br J Haematol. 1999 Apr;105(1):127-30. [http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.1999.01279.x/full link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/10233375 PubMed]
+
# Palumbo A, Avet-Loiseau H, Oliva S, Lokhorst HM, Goldschmidt H, Rosinol L, Richardson P, Caltagirone S, Lahuerta JJ, Facon T, Bringhen S, Gay F, Attal M, Passera R, Spencer A, Offidani M, Kumar S, Musto P, Lonial S, Petrucci MT, Orlowski RZ, Zamagni E, Morgan G, Dimopoulos MA, Durie BG, Anderson KC, Sonneveld P, San Miguel J, Cavo M, Rajkumar SV, Moreau P. Revised International Staging System for multiple myeloma: a report from International Myeloma Working Group. J Clin Oncol. 2015 Sep 10;33(26):2863-9. Epub 2015 Aug 3. [https://doi.org/10.1200/jco.2015.61.2267 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4846284/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26240224/ PubMed]
−
# Berenson JR, Crowley JJ, Grogan TM, Zangmeister J, Briggs AD, Mills GM, Barlogie B, Salmon SE. Maintenance therapy with alternate-day prednisone improves survival in multiple myeloma patients. Blood. 2002 May 1;99(9):3163-8. [http://bloodjournal.hematologylibrary.org/content/99/9/3163.long link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/11964279 PubMed]
 
−
# Dimopoulos MA, Pouli A, Zervas K, Grigoraki V, Symeonidis A, Repoussis P, Mitsouli C, Papanastasiou C, Margaritis D, Tokmaktsis A, Katodritou I, Kokkini G, Terpos E, Vyniou N, Tzilianos M, Chatzivassili A, Kyrtsonis MC, Panayiotidis P, Maniatis A; Greek Myeloma Study Group. Prospective randomized comparison of vincristine, doxorubicin and dexamethasone (VAD) administered as intravenous bolus injection and VAD with liposomal doxorubicin as first-line treatment in multiple myeloma. Ann Oncol. 2003 Jul;14(7):1039-44. [http://annonc.oxfordjournals.org/content/14/7/1039.long link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/12853344 PubMed]
 
−
# Harousseau JL, Attal M, Avet-Loiseau H, Marit G, Caillot D, Mohty M, Lenain P, Hulin C, Facon T, Casassus P, Michallet M, Maisonneuve H, Benboubker L, Maloisel F, Petillon MO, Webb I, Mathiot C, Moreau P. Bortezomib plus dexamethasone is superior to vincristine plus doxorubicin plus dexamethasone as induction treatment prior to autologous stem-cell transplantation in newly diagnosed multiple myeloma: results of the IFM 2005-01 phase III trial. J Clin Oncol. 2010 Oct 20;28(30):4621-9. Epub 2010 Sep 7. [http://jco.ascopubs.org/content/28/30/4621.long link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/20823406 PubMed]
 
  
−
==VAD (Velcade)==
+
==Miscellaneous==
−
VAD: '''<u>V</u>'''elcade, '''<u>A</u>'''driamycin, '''<u>D</u>'''examethasone
+
# Avet-Loiseau H, Attal M, Moreau P, Charbonnel C, Garban F, Hulin C, Leyvraz S, Michallet M, Yakoub-Agha I, Garderet L, Marit G, Michaux L, Voillat L, Renaud M, Grosbois B, Guillerm G, Benboubker L, Monconduit M, Thieblemont C, Casassus P, Caillot D, Stoppa AM, Sotto JJ, Wetterwald M, Dumontet C, Fuzibet JG, Azais I, Dorvaux V, Zandecki M, Bataille R, Minvielle S, Harousseau JL, Facon T, Mathiot C. Genetic abnormalities and survival in multiple myeloma: the experience of the Intergroupe Francophone du Myélome. Blood. 2007 Apr 15;109(8):3489-95. Epub 2007 Jan 5. [https://doi.org/10.1182/blood-2006-08-040410 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17209057/ PubMed]
 +
# Avet-Loiseau H, Hulin C, Campion L, Rodon P, Marit G, Attal M, Royer B, Dib M, Voillat L, Bouscary D, Caillot D, Wetterwald M, Pegourie B, Lepeu G, Corront B, Karlin L, Stoppa AM, Fuzibet JG, Delbrel X, Guilhot F, Kolb B, Decaux O, Lamy T, Garderet L, Allangba O, Lifermann F, Anglaret B, Moreau P, Harousseau JL, Facon T. Chromosomal abnormalities are major prognostic factors in elderly patients with multiple myeloma: the Intergroupe Francophone du Myélome experience. J Clin Oncol. 2013 Aug 1;31(22):2806-9. Epub 2013 Jun 24. [https://doi.org/10.1200/jco.2012.46.2598 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3718879/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23796999/ PubMed]
  
−
===Regimen===
+
=External links=
−
*[[Bortezomib (Velcade)]] 1.3 mg/m2 IV on days 1, 4, 8, 11
+
*[https://www.msmart.org/ Mayo Clinic mSMART (Stratification for Myeloma And Risk-adapted Therapy)]
−
*[[Doxorubicin (Adriamycin)]] 9 mg/m2 IV on days 1-4
 
−
*[[Dexamethasone (Decadron)]] 40 mg PO on days 1-4, 9-12, 17-20
 
  
−
'''21-day cycles x 3 cycles'''
+
=References=
 +
<references/>
 +
<section end=bottom />
  
−
===References===
+
[[Category:Null pages]]
−
# Broyl A, Corthals SL, Jongen JL, van der Holt B, Kuiper R, de Knegt Y, van Duin M, el Jarari L, Bertsch U, Lokhorst HM, Durie BG, Goldschmidt H, Sonneveld P. Mechanisms of peripheral neuropathy associated with bortezomib and vincristine in patients with newly diagnosed multiple myeloma: a prospective analysis of data from the HOVON-65/GMMG-HD4 trial. Lancet Oncol. 2010 Nov;11(11):1057-65. Epub 2010 Sep 21. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2810%2970206-0/fulltext link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/20864405 PubMed]
 
−
 
 
−
==VMP==
 
−
VMP: '''<u>V</u>'''elcade, '''<u>M</u>'''elphalan, '''<u>P</u>'''rednisone
 
−
 
 
−
===Regimen===
 
−
*[[Bortezomib (Velcade)]] 1.3 mg/m2 IV bolus on days 1, 4, 8, 11, 22, 25, 29, 32 of cycles 1-4; 1.3 mg/m2 IV bolus on days 1, 8, 22, 29 of cycles 5-9
 
−
*[[Melphalan (Alkeran)]] 9 mg/m2 PO on days 1-4
 
−
*[[Prednisone (Sterapred)]] 60 mg/m2 PO days 1-4
 
−
 
 
−
'''42-day cycles x 9 cycles'''
 
−
 
 
−
Supportive medication:
 
−
*Bisphosphonate given to patients with myeloma-associated bone disease unless contraindicated
 
−
 
 
−
===References===
 
−
# San Miguel JF, Schlag R, Khuageva NK, Dimopoulos MA, Shpilberg O, Kropff M, Spicka I, Petrucci MT, Palumbo A, Samoilova OS, Dmoszynska A, Abdulkadyrov KM, Schots R, Jiang B, Mateos MV, Anderson KC, Esseltine DL, Liu K, Cakana A, van de Velde H, Richardson PG; VISTA Trial Investigators. Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. N Engl J Med. 2008 Aug 28;359(9):906-17. [http://www.nejm.org/doi/full/10.1056/NEJMoa0801479 link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/18753647 PubMed]
 
−
 
 
−
==VMPT==
 
−
VMPT: '''<u>V</u>'''elcade, '''<u>M</u>'''elphalan, '''<u>P</u>'''rednisone, '''<u>T</u>'''halidomide
 
−
 
 
−
===Regimen===
 
−
*[[Bortezomib (Velcade)]] 1.0-1.3 mg/m2 IV bolus on days 1, 4, 15, 22
 
−
*[[Melphalan (Alkeran)]] 6 mg/m2 PO on days 1-5
 
−
*[[Prednisone (Sterapred)]] 60 mg/m2 PO days 1-5
 
−
*[[Thalidomide (Thalomid)]] 50 mg PO day 1-35
 
−
 
 
−
'''35-day cycles x 6 cycles'''
 
−
 
 
−
===References===
 
−
# Palumbo A, Ambrosini MT, Benevolo G, Pregno P, Pescosta N, Callea V, Cangialosi C, Caravita T, Morabito F, Musto P, Bringhen S, Falco P, Avonto I, Cavallo F, Boccadoro M; Italian Multiple Myeloma Network; Gruppo Italiano Malattie Ematologicche dell'Adulto. Bortezomib, melphalan, prednisone, and thalidomide for relapsed multiple myeloma. Blood. 2007 Apr 1;109(7):2767-72. [http://bloodjournal.hematologylibrary.org/content/109/7/2767.full link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17148584 PubMed]
 
−
 
 
−
==Thalidomide (Thalomid) maintenance after transplant==
 
−
===Regimen===
 
−
*[[Thalidomide (Thalomid)]] 100 mg PO daily x 6 months, starting 3 months after autologous stem cell transplant
 
−
 
 
−
===References===
 
−
# Abdelkefi A, Ladeb S, Torjman L, Othman TB, Lakhal A, Romdhane NB, Omri HE, Elloumi M, Belaaj H, Jeddi R, Aissaouï L, Ksouri H, Hassen AB, Msadek F, Saad A, Hsaïri M, Boukef K, Amouri A, Louzir H, Dellagi K, Abdeladhim AB; Tunisian Multiple Myeloma Study Group. Single autologous stem-cell transplantation followed by maintenance therapy with thalidomide is superior to double autologous transplantation in multiple myeloma: results of a multicenter randomized clinical trial. Blood. 2008 Feb 15;111(4):1805-10. Epub 2007 Sep 17. [http://bloodjournal.hematologylibrary.org/content/111/4/1805.long link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17875806 PubMed]
 

Latest revision as of 11:59, 6 July 2024

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Section editor
Samuelrubinstein.jpg
 Samuel M. Rubinstein, MD
University of North Carolina
Chapel Hill, NC, USA
LinkedIn

Are you looking for a regimen but can't find it here? It is possible that we've moved it to the historical regimens page. For placebo or observational studies in this condition, please visit this page. If you still can't find it, please let us know so we can add it!

Note: due to its size/complexity, the multiple myeloma page has been split into sub-pages:

This page will remain as a consolidated location for guidelines and prognostic information.

  • We have moved How I Treat articles to a dedicated page.


Guidelines

Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.

ASCO/CCO

BSH/UKMF

European Myeloma Network (EMN)

EHA/ESMO

IMWG

NCCN

SITC

Response criteria

Prognosis

Durie-Salmon Staging System - 1975

Composed of four factors with a modifier based on renal function

  • Serum levels of monoclonal protein (only defined for IgM, IgA, and Bence-Jones)
  • Number of lytic bone lesions
  • Hemoglobin
  • Serum calcium level

Risk stratification

  • Stage I: (must meet ALL criteria)
    • Hemoglobin greater than 10 g/dL
    • Calcium normal or less than or equal to 12 mg/dL
    • Skeletal survey with normal bone structure (scale 0) or solitary bone plasmacytoma only
    • Monoclonal protein relatively small (IgG M-spike value less than 5 g/dL OR IgA M-spike value less than 3 g/dL OR urine light chain protein less than 4 g/24 hr)
  • Stage II: not stage I or stage III
  • Stage III: (if meets ANY of the criteria)
    • Hemoglobin less than 8.5 g/dL
    • Calcium greater than 12 mg/dL
    • Skeletal survey with extensive skeletal destruction and major fractures
    • Monoclonal protein relatively large (IgG M-spike value greater than 7 g/dL OR IgA M-spike value greater than 5 g/dL OR urine light chain protein greater than 12 g/24 hr)

Modifier

  • A: relatively normal creatinine (less than 2 mg/dL)
  • B: creatinine greater than or equal to 2 mg/dL

References

  1. Durie BG, Salmon SE. A clinical staging system for multiple myeloma. Correlation of measured myeloma cell mass with presenting clinical features, response to treatment, and survival. Cancer. 1975 Sep;36(3):842-54. link to original article PubMed

International Staging System (ISS) - 2005

Composed of two factors

  • Serum albumin level
  • Serum beta-2 microglobulin level

Risk stratification

  • Stage I: Median survival of 62 months
    • Beta-2 microglobulin less than 3.5 mg/l
    • Albumin greater than or equal to 3.5 g/dl
  • Stage II: Median survival of 44 months
    • Not meeting stage I or stage III criteria
  • Stage III: Median survival of 29 months
    • Beta-2 microglobulin greater than or equal to 5.5 mg/l

References

  1. Greipp PR, San Miguel J, Durie BG, Crowley JJ, Barlogie B, Bladé J, Boccadoro M, Child JA, Avet-Loiseau H, Kyle RA, Lahuerta JJ, Ludwig H, Morgan G, Powles R, Shimizu K, Shustik C, Sonneveld P, Tosi P, Turesson I, Westin J. International staging system for multiple myeloma. J Clin Oncol. 2005 May 20;23(15):3412-20. Epub 2005 Apr 4. link to original article PubMed
  2. Kyle RA, Rajkumar SV. Criteria for diagnosis, staging, risk stratification and response assessment of multiple myeloma. Leukemia. 2009 Jan;23(1):3-9. Epub 2008 Oct 30. link to original article link to PMC article PubMed

IMWG consensus on risk stratification - 2013

Composed of four factors

  • Serum albumin level
  • Serum beta-2 microglobulin level
  • Age
  • Chromosomal abnormalities detected by interphase fluorescent in situ hybridization (FISH)

Risk stratification

  • Low risk: (must meet all criteria) Median survival of greater than 10 years
    • ISS Stage I or II
    • Age less than 55 years
    • Absence of the following: del(17p13), t(4;14), +1q21
  • Standard risk: Median survival of 7 years
    • Not meeting low risk or high risk criteria
  • High risk: (if meets both criteria) Median survival of 2 years
    • ISS Stage II or III
    • Either of the following: del(17p13) or t(4;14)

References

  1. Chng WJ, Dispenzieri A, Chim CS, Fonseca R, Goldschmidt H, Lentzsch S, Munshi N, Palumbo A, San Miguel J, Sonneveld P, Cavo M, Usmani S, Durie BG, Avet-Loiseau H; International Myeloma Working Group. IMWG consensus on risk stratification in multiple myeloma. Leukemia. 2014 Feb;28(2):269-77. Epub 2013 Aug 26. link to original article PubMed

Revised International Staging System (R-ISS) - 2015

Composed of four factors

  • Serum albumin level
  • Serum beta-2 microglobulin level
  • Serum LDH
  • Chromosomal abnormalities detected by interphase fluorescent in situ hybridization (FISH)

Risk stratification

  • Low risk: 5-year overall survival = 82%
    • Beta-2 microglobulin less than 3.5 mg/l
    • Albumin less than or equal to 3.5 g/dl
    • LDH less than the upper limit of normal range
    • Absence of the following: del(17p), t(4;14), t(14;16)
  • Intermediate risk: 5-year overall survival = 62%
    • Not meeting low risk or high risk criteria
  • High risk: (if meets ANY of the criteria) 5-year overall survival = 40%
    • Beta-2 microglobulin greater than or equal to 5.5 mg/l
    • LDH greater than the upper limit of normal range
    • Any of the following: del(17p), t(4;14), t(14;16)

References

  1. Palumbo A, Avet-Loiseau H, Oliva S, Lokhorst HM, Goldschmidt H, Rosinol L, Richardson P, Caltagirone S, Lahuerta JJ, Facon T, Bringhen S, Gay F, Attal M, Passera R, Spencer A, Offidani M, Kumar S, Musto P, Lonial S, Petrucci MT, Orlowski RZ, Zamagni E, Morgan G, Dimopoulos MA, Durie BG, Anderson KC, Sonneveld P, San Miguel J, Cavo M, Rajkumar SV, Moreau P. Revised International Staging System for multiple myeloma: a report from International Myeloma Working Group. J Clin Oncol. 2015 Sep 10;33(26):2863-9. Epub 2015 Aug 3. link to original article link to PMC article PubMed

Miscellaneous

  1. Avet-Loiseau H, Attal M, Moreau P, Charbonnel C, Garban F, Hulin C, Leyvraz S, Michallet M, Yakoub-Agha I, Garderet L, Marit G, Michaux L, Voillat L, Renaud M, Grosbois B, Guillerm G, Benboubker L, Monconduit M, Thieblemont C, Casassus P, Caillot D, Stoppa AM, Sotto JJ, Wetterwald M, Dumontet C, Fuzibet JG, Azais I, Dorvaux V, Zandecki M, Bataille R, Minvielle S, Harousseau JL, Facon T, Mathiot C. Genetic abnormalities and survival in multiple myeloma: the experience of the Intergroupe Francophone du Myélome. Blood. 2007 Apr 15;109(8):3489-95. Epub 2007 Jan 5. link to original article PubMed
  2. Avet-Loiseau H, Hulin C, Campion L, Rodon P, Marit G, Attal M, Royer B, Dib M, Voillat L, Bouscary D, Caillot D, Wetterwald M, Pegourie B, Lepeu G, Corront B, Karlin L, Stoppa AM, Fuzibet JG, Delbrel X, Guilhot F, Kolb B, Decaux O, Lamy T, Garderet L, Allangba O, Lifermann F, Anglaret B, Moreau P, Harousseau JL, Facon T. Chromosomal abnormalities are major prognostic factors in elderly patients with multiple myeloma: the Intergroupe Francophone du Myélome experience. J Clin Oncol. 2013 Aug 1;31(22):2806-9. Epub 2013 Jun 24. link to original article link to PMC article PubMed

External links

References

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