Difference between revisions of "Waldenström macroglobulinemia - historical"

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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the [http://www.nccn.org/professionals/physician_gls/f_guidelines.asp NCCN Guidelines]. Is there a regimen missing from this list? Please go to the [[Waldenström macroglobulinemia|main WM regimen page]] to find other regimens.
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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? Please go to the [[Waldenström macroglobulinemia|main WM regimen page]] to find other regimens.
  
 
{| class="wikitable" style="float:right; margin-right: 5px;"
 
{| class="wikitable" style="float:right; margin-right: 5px;"
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=First-line therapy=
 
=First-line therapy=
 
==Ofatumumab monotherapy {{#subobject:ed42ea|Regimen=1}}==
 
==Ofatumumab monotherapy {{#subobject:ed42ea|Regimen=1}}==
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<div class="toccolours" style="background-color:#ee6b6e">
−
 
 
 
===Regimen variant #1 {{#subobject:82d5c8|Variant=1}}===
 
===Regimen variant #1 {{#subobject:82d5c8|Variant=1}}===
−
{| class="wikitable" style="width: 40%; text-align:center;"  
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{| class="wikitable sortable" style="width: 60%; text-align:center;"  
−
!style="width: 25%"|Study
+
!style="width: 33%"|Study
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
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!style="width: 33%"|Dates of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
−
|[https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(16)30166-1/fulltext Furman et al. 2016 (GSK 110921)]
+
|[https://doi.org/10.1016/S2352-3026(16)30166-1 Furman et al. 2016 (GSK 110921)]
 +
|2009-03-17 to 2011-02-24
 
|style="background-color:#91cf61"|Phase 2
 
|style="background-color:#91cf61"|Phase 2
 
|-
 
|-
 
|}
 
|}
 
''Note: This study used two dosing schemas, based on a mid-study amendment. See paper for details about redosing based on response. It is not clear from the abstract how many patients were untreated versus relapsed. As of 10/15/2020, ofatumumab is no longer available for commercial purchase and is not being made available for this indication.''
 
''Note: This study used two dosing schemas, based on a mid-study amendment. See paper for details about redosing based on response. It is not clear from the abstract how many patients were untreated versus relapsed. As of 10/15/2020, ofatumumab is no longer available for commercial purchase and is not being made available for this indication.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Ofatumumab (Arzerra)]] 300 mg IV once on day 1, then 1000 mg IV once per day on days 8, 15, 22
 
*[[Ofatumumab (Arzerra)]] 300 mg IV once on day 1, then 1000 mg IV once per day on days 8, 15, 22
  
 
'''4-week course'''
 
'''4-week course'''
−
 
+
</div></div><br>
 +
<div class="toccolours" style="background-color:#ee6b6e">
 
===Regimen variant #2 {{#subobject:839bc8|Variant=1}}===
 
===Regimen variant #2 {{#subobject:839bc8|Variant=1}}===
−
{| class="wikitable" style="width: 40%; text-align:center;"  
+
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
−
!style="width: 25%"|Study
+
!style="width: 33%"|Study
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 33%"|Dates of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
−
|[https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(16)30166-1/fulltext Furman et al. 2016 (GSK 110921)]
+
|[https://doi.org/10.1016/S2352-3026(16)30166-1 Furman et al. 2016 (GSK 110921)]
 +
|2009-03-17 to 2011-02-24
 
|style="background-color:#91cf61"|Phase 2
 
|style="background-color:#91cf61"|Phase 2
 
|-
 
|-
 
|}
 
|}
 
''Note: This study used two dosing schemas, based on a mid-study amendment. See paper for details about redosing based on response. It is not clear from the abstract how many patients were untreated versus relapsed. As of 10/15/2020, ofatumumab is no longer available for commercial purchase and is not being made available for this indication.''
 
''Note: This study used two dosing schemas, based on a mid-study amendment. See paper for details about redosing based on response. It is not clear from the abstract how many patients were untreated versus relapsed. As of 10/15/2020, ofatumumab is no longer available for commercial purchase and is not being made available for this indication.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Ofatumumab (Arzerra)]] 300 mg IV once on day 1, then 2000 mg IV once per day on days 8, 15, 22, 29
 
*[[Ofatumumab (Arzerra)]] 300 mg IV once on day 1, then 2000 mg IV once per day on days 8, 15, 22, 29
  
 
'''5-week course'''
 
'''5-week course'''
−
 
+
</div></div>
 
===References===
 
===References===
−
<!-- # '''Abstract:''' Furman, Richard R., Eradat, Herbert, DiRienzo, Christine Gabriella, Hayman, Suzanne R, Hofmeister, Craig C., Avignon, Nathalie A., Leonard, John P., Coleman, Morton, Advani, Ranjana, Switzky, Julie C., Liao, Qiming, Shah, Damini N., Lisby, Steen, Lin, Thomas S. A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia. Blood 2011 118:3701 [http://www.bloodjournal.org/content/118/21/3701.abstract link to abstract] -->
+
<!-- # '''Abstract:''' Furman, Richard R., Eradat, Herbert, DiRienzo, Christine Gabriella, Hayman, Suzanne R, Hofmeister, Craig C., Avignon, Nathalie A., Leonard, John P., Coleman, Morton, Advani, Ranjana, Switzky, Julie C., Liao, Qiming, Shah, Damini N., Lisby, Steen, Lin, Thomas S. A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia. Blood 2011 118:3701-->
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# '''GSK 110921:''' Furman RR, Eradat HA, DiRienzo CG, Hofmeister CC, Hayman SR, Leonard JP, Coleman M, Advani R, Chanan-Khan A, Switzky J, Liao QM, Shah D, Jewell RC, Lisby S, Lin TS. Once-weekly ofatumumab in untreated or relapsed Waldenström's macroglobulinaemia: an open-label, single-arm, phase 2 study. Lancet Haematol. 2017 Jan;4(1):e24-e34. Epub 2016 Nov 30. [https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(16)30166-1/fulltext link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5484580/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27914971 PubMed] NCT00811733
+
# '''GSK 110921:''' Furman RR, Eradat HA, DiRienzo CG, Hofmeister CC, Hayman SR, Leonard JP, Coleman M, Advani R, Chanan-Khan A, Switzky J, Liao QM, Shah D, Jewell RC, Lisby S, Lin TS. Once-weekly ofatumumab in untreated or relapsed Waldenström's macroglobulinaemia: an open-label, single-arm, phase 2 study. Lancet Haematol. 2017 Jan;4(1):e24-e34. Epub 2016 Nov 30. [https://doi.org/10.1016/S2352-3026(16)30166-1 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5484580/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27914971/ PubMed] [https://clinicaltrials.gov/study/NCT00811733 NCT00811733]
  
 
=Relapsed or refractory=
 
=Relapsed or refractory=
 
==Ofatumumab monotherapy {{#subobject:940cf5|Regimen=1}}==
 
==Ofatumumab monotherapy {{#subobject:940cf5|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#ee6b6e">
 
===Regimen variant #1 {{#subobject:81ncy8|Variant=1}}===
 
===Regimen variant #1 {{#subobject:81ncy8|Variant=1}}===
−
{| class="wikitable" style="width: 40%; text-align:center;"  
+
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
−
!style="width: 25%"|Study
+
!style="width: 33%"|Study
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 33%"|Dates of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
−
|[https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(16)30166-1/fulltext Furman et al. 2016 (GSK 110921)]
+
|[https://doi.org/10.1016/S2352-3026(16)30166-1 Furman et al. 2016 (GSK 110921)]
 +
|2009-03-17 to 2011-02-24
 
|style="background-color:#91cf61"|Phase 2
 
|style="background-color:#91cf61"|Phase 2
 
|-
 
|-
 
|}
 
|}
 
''Note: This study used two dosing schemas, based on a mid-study amendment. See paper for details about redosing based on response. It is not clear from the abstract how many patients were untreated versus relapsed. As of 10/15/2020, ofatumumab is no longer available for commercial purchase and is not being made available for this indication.''
 
''Note: This study used two dosing schemas, based on a mid-study amendment. See paper for details about redosing based on response. It is not clear from the abstract how many patients were untreated versus relapsed. As of 10/15/2020, ofatumumab is no longer available for commercial purchase and is not being made available for this indication.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Ofatumumab (Arzerra)]] 300 mg IV once on day 1, then 1000 mg IV once per day on days 8, 15, 22
 
*[[Ofatumumab (Arzerra)]] 300 mg IV once on day 1, then 1000 mg IV once per day on days 8, 15, 22
  
 
'''4-week course'''
 
'''4-week course'''
−
 
+
</div></div><br>
 +
<div class="toccolours" style="background-color:#ee6b6e">
 
===Regimen variant #2 {{#subobject:8a0bj8|Variant=1}}===
 
===Regimen variant #2 {{#subobject:8a0bj8|Variant=1}}===
−
{| class="wikitable" style="width: 40%; text-align:center;"  
+
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
−
!style="width: 25%"|Study
+
!style="width: 33%"|Study
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 33%"|Dates of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
−
|[https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(16)30166-1/fulltext Furman et al. 2016 (GSK 110921)]
+
|[https://doi.org/10.1016/S2352-3026(16)30166-1 Furman et al. 2016 (GSK 110921)]
 +
|2009-03-17 to 2011-02-24
 
|style="background-color:#91cf61"|Phase 2
 
|style="background-color:#91cf61"|Phase 2
 
|-
 
|-
 
|}
 
|}
 
''Note: This study used two dosing schemas, based on a mid-study amendment. See paper for details about redosing based on response. It is not clear from the abstract how many patients were untreated versus relapsed. As of 10/15/2020, ofatumumab is no longer available for commercial purchase and is not being made available for this indication.''
 
''Note: This study used two dosing schemas, based on a mid-study amendment. See paper for details about redosing based on response. It is not clear from the abstract how many patients were untreated versus relapsed. As of 10/15/2020, ofatumumab is no longer available for commercial purchase and is not being made available for this indication.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Ofatumumab (Arzerra)]] 300 mg IV once on day 1, then 2000 mg IV once per day on days 8, 15, 22, 29
 
*[[Ofatumumab (Arzerra)]] 300 mg IV once on day 1, then 2000 mg IV once per day on days 8, 15, 22, 29
  
 
'''5-week course'''
 
'''5-week course'''
−
 
+
</div></div>
 
===References===
 
===References===
−
<!-- # '''Abstract:''' Furman, Richard R., Eradat, Herbert, DiRienzo, Christine Gabriella, Hayman, Suzanne R, Hofmeister, Craig C., Avignon, Nathalie A., Leonard, John P., Coleman, Morton, Advani, Ranjana, Switzky, Julie C., Liao, Qiming, Shah, Damini N., Lisby, Steen, Lin, Thomas S. A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia. Blood 2011 118:3701 [http://www.bloodjournal.org/content/118/21/3701.abstract link to abstract] -->
+
<!-- # '''Abstract:''' Furman, Richard R., Eradat, Herbert, DiRienzo, Christine Gabriella, Hayman, Suzanne R, Hofmeister, Craig C., Avignon, Nathalie A., Leonard, John P., Coleman, Morton, Advani, Ranjana, Switzky, Julie C., Liao, Qiming, Shah, Damini N., Lisby, Steen, Lin, Thomas S. A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia. Blood 2011 118:3701 -->
−
# '''GSK 110921:''' Furman RR, Eradat HA, DiRienzo CG, Hofmeister CC, Hayman SR, Leonard JP, Coleman M, Advani R, Chanan-Khan A, Switzky J, Liao QM, Shah D, Jewell RC, Lisby S, Lin TS. Once-weekly ofatumumab in untreated or relapsed Waldenström's macroglobulinaemia: an open-label, single-arm, phase 2 study. Lancet Haematol. 2017 Jan;4(1):e24-e34. Epub 2016 Nov 30. [https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(16)30166-1/fulltext link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5484580/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27914971 PubMed] NCT00811733
+
# '''GSK 110921:''' Furman RR, Eradat HA, DiRienzo CG, Hofmeister CC, Hayman SR, Leonard JP, Coleman M, Advani R, Chanan-Khan A, Switzky J, Liao QM, Shah D, Jewell RC, Lisby S, Lin TS. Once-weekly ofatumumab in untreated or relapsed Waldenström's macroglobulinaemia: an open-label, single-arm, phase 2 study. Lancet Haematol. 2017 Jan;4(1):e24-e34. Epub 2016 Nov 30. [https://doi.org/10.1016/S2352-3026(16)30166-1 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5484580/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27914971/ PubMed] [https://clinicaltrials.gov/study/NCT00811733 NCT00811733]
  
 
==Panobinostat monotherapy {{#subobject:f079ae|Regimen=1}}==
 
==Panobinostat monotherapy {{#subobject:f079ae|Regimen=1}}==
−
 
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<div class="toccolours" style="background-color:#ee6b6e">
 
===Regimen {{#subobject:2221fe|Variant=1}}===
 
===Regimen {{#subobject:2221fe|Variant=1}}===
−
{| class="wikitable" style="width: 40%; text-align:center;"  
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{| class="wikitable sortable" style="width: 60%; text-align:center;"  
−
!style="width: 25%"|Study
+
!style="width: 33%"|Study
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
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!style="width: 33%"|Dates of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3578951/ Ghobrial et al. 2013 (DFCI 09-071)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3578951/ Ghobrial et al. 2013 (DFCI 09-071)]
 +
|2009-07 to 2011-03
 
|style="background-color:#91cf61"|Phase 2
 
|style="background-color:#91cf61"|Phase 2
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Panobinostat (Farydak)]] 30 mg PO 3 days per week (Mondays, Wednesdays, and Fridays)
 
*[[Panobinostat (Farydak)]] 30 mg PO 3 days per week (Mondays, Wednesdays, and Fridays)
  
 
'''28-day cycles'''
 
'''28-day cycles'''
−
+
</div></div>
 
===References===
 
===References===
−
# '''DFCI 09-071:''' Ghobrial IM, Campigotto F, Murphy TJ, Boswell EN, Banwait R, Azab F, Chuma S, Kunsman J, Donovan A, Masood F, Warren D, Rodig S, Anderson KC, Richardson PG, Weller E, Matous J. Results of a phase 2 trial of the single-agent histone deacetylase inhibitor panobinostat in patients with relapsed/refractory Waldenstrom macroglobulinemia. Blood. 2013 Feb 21;121(8):1296-303. Epub 2013 Jan 3. [http://www.bloodjournal.org/content/121/8/1296.long link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3578951/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23287861 PubMed] NCT00936611
+
# '''DFCI 09-071:''' Ghobrial IM, Campigotto F, Murphy TJ, Boswell EN, Banwait R, Azab F, Chuma S, Kunsman J, Donovan A, Masood F, Warren D, Rodig S, Anderson KC, Richardson PG, Weller E, Matous J. Results of a phase 2 trial of the single-agent histone deacetylase inhibitor panobinostat in patients with relapsed/refractory Waldenstrom macroglobulinemia. Blood. 2013 Feb 21;121(8):1296-303. Epub 2013 Jan 3. [https://doi.org/10.1182/blood-2012-06-439307 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3578951/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23287861/ PubMed] [https://clinicaltrials.gov/study/NCT00936611 NCT00936611]
  
 
[[Category:Waldenström macroglobulinemia regimens]]
 
[[Category:Waldenström macroglobulinemia regimens]]

Latest revision as of 18:30, 27 June 2024

Back to Top

The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? Please go to the main WM regimen page to find other regimens.

3 regimens on this page
5 variants on this page


First-line therapy

Ofatumumab monotherapy

Regimen variant #1

Study Dates of enrollment Evidence
Furman et al. 2016 (GSK 110921) 2009-03-17 to 2011-02-24 Phase 2

Note: This study used two dosing schemas, based on a mid-study amendment. See paper for details about redosing based on response. It is not clear from the abstract how many patients were untreated versus relapsed. As of 10/15/2020, ofatumumab is no longer available for commercial purchase and is not being made available for this indication.

Targeted therapy

4-week course


Regimen variant #2

Study Dates of enrollment Evidence
Furman et al. 2016 (GSK 110921) 2009-03-17 to 2011-02-24 Phase 2

Note: This study used two dosing schemas, based on a mid-study amendment. See paper for details about redosing based on response. It is not clear from the abstract how many patients were untreated versus relapsed. As of 10/15/2020, ofatumumab is no longer available for commercial purchase and is not being made available for this indication.

Targeted therapy

5-week course

References

  1. GSK 110921: Furman RR, Eradat HA, DiRienzo CG, Hofmeister CC, Hayman SR, Leonard JP, Coleman M, Advani R, Chanan-Khan A, Switzky J, Liao QM, Shah D, Jewell RC, Lisby S, Lin TS. Once-weekly ofatumumab in untreated or relapsed Waldenström's macroglobulinaemia: an open-label, single-arm, phase 2 study. Lancet Haematol. 2017 Jan;4(1):e24-e34. Epub 2016 Nov 30. link to original article contains dosing details in abstract link to PMC article PubMed NCT00811733

Relapsed or refractory

Ofatumumab monotherapy

Regimen variant #1

Study Dates of enrollment Evidence
Furman et al. 2016 (GSK 110921) 2009-03-17 to 2011-02-24 Phase 2

Note: This study used two dosing schemas, based on a mid-study amendment. See paper for details about redosing based on response. It is not clear from the abstract how many patients were untreated versus relapsed. As of 10/15/2020, ofatumumab is no longer available for commercial purchase and is not being made available for this indication.

Targeted therapy

4-week course


Regimen variant #2

Study Dates of enrollment Evidence
Furman et al. 2016 (GSK 110921) 2009-03-17 to 2011-02-24 Phase 2

Note: This study used two dosing schemas, based on a mid-study amendment. See paper for details about redosing based on response. It is not clear from the abstract how many patients were untreated versus relapsed. As of 10/15/2020, ofatumumab is no longer available for commercial purchase and is not being made available for this indication.

Targeted therapy

5-week course

References

  1. GSK 110921: Furman RR, Eradat HA, DiRienzo CG, Hofmeister CC, Hayman SR, Leonard JP, Coleman M, Advani R, Chanan-Khan A, Switzky J, Liao QM, Shah D, Jewell RC, Lisby S, Lin TS. Once-weekly ofatumumab in untreated or relapsed Waldenström's macroglobulinaemia: an open-label, single-arm, phase 2 study. Lancet Haematol. 2017 Jan;4(1):e24-e34. Epub 2016 Nov 30. link to original article contains dosing details in abstract link to PMC article PubMed NCT00811733

Panobinostat monotherapy

Regimen

Study Dates of enrollment Evidence
Ghobrial et al. 2013 (DFCI 09-071) 2009-07 to 2011-03 Phase 2

Targeted therapy

28-day cycles

References

  1. DFCI 09-071: Ghobrial IM, Campigotto F, Murphy TJ, Boswell EN, Banwait R, Azab F, Chuma S, Kunsman J, Donovan A, Masood F, Warren D, Rodig S, Anderson KC, Richardson PG, Weller E, Matous J. Results of a phase 2 trial of the single-agent histone deacetylase inhibitor panobinostat in patients with relapsed/refractory Waldenstrom macroglobulinemia. Blood. 2013 Feb 21;121(8):1296-303. Epub 2013 Jan 3. link to original article contains dosing details in manuscript link to PMC article PubMed NCT00936611
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