Difference between revisions of "Myelodysplastic syndrome - null regimens"

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=Lower-risk MDS, all lines of therapy=
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==Placebo==
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<div class="toccolours" style="background-color:#eeeeee">
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===Regimen===
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{| class="wikitable sortable" style="width: 100%; text-align:center;"
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!style="width: 20%"|Study
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!style="width: 20%"|Dates of enrollment
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!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
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!style="width: 20%"|Comparator
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
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|-
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|[http://www.bloodjournal.org/content/118/14/3765 Fenaux et al. 2011 (CC-5013-MDS-004)]
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|2005-2007
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|style="background-color:#1a9851"|Phase 3 (C)
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|1. [[Myelodysplastic_syndrome#Lenalidomide_monotherapy|Lenalidomide]]; 5 mg<br>2. [[Myelodysplastic_syndrome#Lenalidomide_monotherapy|Lenalidomide]]; 10 mg 21/28
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| style="background-color:#d73027" |Inferior primary endpoint
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|-
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|[https://doi.org/10.1200/jco.2015.66.0118 Santini et al. 2016 (MDS-005)]
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|2010-2013
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|style="background-color:#1a9851"|Phase 3 (C)
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|[[Myelodysplastic_syndrome#Lenalidomide_monotherapy|Lenalidomide]]
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|style="background-color:#d73027"|Inferior RBC transfusion independence at 8 or more weeks
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|-
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|[https://doi.org/10.1056/NEJMoa1908892 Fenaux et al. 2020 (MEDALIST)]
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|2016-03 to 2017-06
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| style="background-color:#1a9851" |Phase 3 (C)
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|[[Myelodysplastic_syndrome#Luspatercept_monotherapy|Luspatercept]]
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|style="background-color:#d73027"|Inferior transfusion independence
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|-
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|}
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''No active antineoplastic treatment.''
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</div></div>
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===References===
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# '''CC-5013-MDS-004:''' Fenaux P, Giagounidis A, Selleslag D, Beyne-Rauzy O, Mufti G, Mittelman M, Muus P, Te Boekhorst P, Sanz G, Del Cañizo C, Guerci-Bresler A, Nilsson L, Platzbecker U, Lübbert M, Quesnel B, Cazzola M, Ganser A, Bowen D, Schlegelberger B, Aul C, Knight R, Francis J, Fu T, Hellström-Lindberg E; MDS-004 Lenalidomide del5q Study Group. A randomized phase 3 study of lenalidomide versus placebo in RBC transfusion-dependent patients with low-/intermediate-1-risk myelodysplastic syndromes with del5q. Blood. 2011 Oct 6;118(14):3765-76. Epub 2011 Jul 13. [http://www.bloodjournal.org/content/118/14/3765 link to original article] [https://pubmed.ncbi.nlm.nih.gov/21753188/ PubMed] [https://clinicaltrials.gov/study/NCT00179621 NCT00179621]
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<!-- Presented at the 56th Annual Meeting of the American Society of Hematology, San Francisco, CA, December 6-9, 2014; 13th International Symposium on Myelodysplastic Syndromes, Washington, DC, April 29-May 2, 2015; and 20th Congress of the European Hematology Association, Vienna, Austria, June 11-14, 2015. -->
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# '''MDS-005:''' Santini V, Almeida A, Giagounidis A, Gröpper S, Jonasova A, Vey N, Mufti GJ, Buckstein R, Mittelman M, Platzbecker U, Shpilberg O, Ram R, Del Cañizo C, Gattermann N, Ozawa K, Risueño A, MacBeth KJ, Zhong J, Séguy F, Hoenekopp A, Beach CL, Fenaux P. Randomized phase III study of lenalidomide versus placebo in RBC transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes and ineligible for or refractory to erythropoiesis-stimulating agents. J Clin Oncol. 2016 Sep 1;34(25):2988-96. Epub 2016 Jun 27. [https://doi.org/10.1200/jco.2015.66.0118 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27354480/ PubMed] [https://clinicaltrials.gov/study/NCT01029262 NCT01029262]
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# '''EPOANE3021:''' Fenaux P, Santini V, Spiriti MAA, Giagounidis A, Schlag R, Radinoff A, Gercheva-Kyuchukova L, Anagnostopoulos A, Oliva EN, Symeonidis A, Berger MH, Götze KS, Potamianou A, Haralampiev H, Wapenaar R, Milionis I, Platzbecker U. A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-α in anemic patients with low-risk MDS. Leukemia. 2018 Dec;32(12):2648-2658. Epub 2018 Mar 30. [https://doi.org/10.1038/s41375-018-0118-9 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6286328/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29895954/ PubMed] [https://clinicaltrials.gov/study/NCT01381809 NCT01381809]
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# '''MEDALIST:''' Fenaux P, Platzbecker U, Mufti GJ, Garcia-Manero G, Buckstein R, Santini V, Díez-Campelo M, Finelli C, Cazzola M, Ilhan O, Sekeres MA, Falantes JF, Arrizabalaga B, Salvi F, Giai V, Vyas P, Bowen D, Selleslag D, DeZern AE, Jurcic JG, Germing U, Götze KS, Quesnel B, Beyne-Rauzy O, Cluzeau T, Voso MT, Mazure D, Vellenga E, Greenberg PL, Hellström-Lindberg E, Zeidan AM, Adès L, Verma A, Savona MR, Laadem A, Benzohra A, Zhang J, Rampersad A, Dunshee DR, Linde PG, Sherman ML, Komrokji RS, List AF. Luspatercept in Patients with Lower-Risk Myelodysplastic Syndromes. N Engl J Med. 2020 Jan 9;382(2):140-151. [https://doi.org/10.1056/NEJMoa1908892 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31914241/ PubMed] [https://clinicaltrials.gov/study/NCT02631070 NCT02631070]
  
 
[[Category:Myelodysplastic syndrome regimens]]
 
[[Category:Myelodysplastic syndrome regimens]]

Revision as of 12:11, 14 October 2023

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main MDS page for regimens that include active anticancer treatment.


Lower-risk MDS, all lines of therapy

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Fenaux et al. 2011 (CC-5013-MDS-004) 2005-2007 Phase 3 (C) 1. Lenalidomide; 5 mg
2. Lenalidomide; 10 mg 21/28 		Inferior primary endpoint
Santini et al. 2016 (MDS-005) 2010-2013 Phase 3 (C) Lenalidomide Inferior RBC transfusion independence at 8 or more weeks
Fenaux et al. 2020 (MEDALIST) 2016-03 to 2017-06 Phase 3 (C) Luspatercept Inferior transfusion independence

No active antineoplastic treatment.

References

  1. CC-5013-MDS-004: Fenaux P, Giagounidis A, Selleslag D, Beyne-Rauzy O, Mufti G, Mittelman M, Muus P, Te Boekhorst P, Sanz G, Del Cañizo C, Guerci-Bresler A, Nilsson L, Platzbecker U, Lübbert M, Quesnel B, Cazzola M, Ganser A, Bowen D, Schlegelberger B, Aul C, Knight R, Francis J, Fu T, Hellström-Lindberg E; MDS-004 Lenalidomide del5q Study Group. A randomized phase 3 study of lenalidomide versus placebo in RBC transfusion-dependent patients with low-/intermediate-1-risk myelodysplastic syndromes with del5q. Blood. 2011 Oct 6;118(14):3765-76. Epub 2011 Jul 13. link to original article PubMed NCT00179621
  2. MDS-005: Santini V, Almeida A, Giagounidis A, Gröpper S, Jonasova A, Vey N, Mufti GJ, Buckstein R, Mittelman M, Platzbecker U, Shpilberg O, Ram R, Del Cañizo C, Gattermann N, Ozawa K, Risueño A, MacBeth KJ, Zhong J, Séguy F, Hoenekopp A, Beach CL, Fenaux P. Randomized phase III study of lenalidomide versus placebo in RBC transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes and ineligible for or refractory to erythropoiesis-stimulating agents. J Clin Oncol. 2016 Sep 1;34(25):2988-96. Epub 2016 Jun 27. link to original article PubMed NCT01029262
  3. EPOANE3021: Fenaux P, Santini V, Spiriti MAA, Giagounidis A, Schlag R, Radinoff A, Gercheva-Kyuchukova L, Anagnostopoulos A, Oliva EN, Symeonidis A, Berger MH, Götze KS, Potamianou A, Haralampiev H, Wapenaar R, Milionis I, Platzbecker U. A phase 3 randomized, placebo-controlled study assessing the efficacy and safety of epoetin-α in anemic patients with low-risk MDS. Leukemia. 2018 Dec;32(12):2648-2658. Epub 2018 Mar 30. link to original article link to PMC article PubMed NCT01381809
  4. MEDALIST: Fenaux P, Platzbecker U, Mufti GJ, Garcia-Manero G, Buckstein R, Santini V, Díez-Campelo M, Finelli C, Cazzola M, Ilhan O, Sekeres MA, Falantes JF, Arrizabalaga B, Salvi F, Giai V, Vyas P, Bowen D, Selleslag D, DeZern AE, Jurcic JG, Germing U, Götze KS, Quesnel B, Beyne-Rauzy O, Cluzeau T, Voso MT, Mazure D, Vellenga E, Greenberg PL, Hellström-Lindberg E, Zeidan AM, Adès L, Verma A, Savona MR, Laadem A, Benzohra A, Zhang J, Rampersad A, Dunshee DR, Linde PG, Sherman ML, Komrokji RS, List AF. Luspatercept in Patients with Lower-Risk Myelodysplastic Syndromes. N Engl J Med. 2020 Jan 9;382(2):140-151. link to original article contains dosing details in manuscript PubMed NCT02631070
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