Pomalidomide plus low-dose dexamethasone in myeloma refractory to both bortezomib and lenalidomide: Comparison of 2 dosing strategies in dual-refractory disease

Martha Lacy, Jacob B. Allred, Morie Gertz, Suzanne R. Hayman, Kristen Detweiler Short, Francis Buadi, Angela Dispenzieri, Shaji K Kumar, Philip R. Greipp, John A. Lust, Stephen J Russell, David M Dingli, Steven Zeldenrust, Rafael Fonseca, Peter Leif Bergsagel, Vivek Roy, Alexander Keith Stewart, Kristina Laumann, Sumithra J Mandrekar, Craig ReederS Vincent Rajkumar, Joseph R Mikhael

Research output: Contribution to journalArticle

173 Citations (Scopus)

Abstract

Pomalidomide at doses of 2 or 4 mg/d has demonstrated excellent activity in patients with multiple myeloma (MM). We opened 2 sequential phase 2 trials using the pomalidomide with weekly dexamethasone (Pom/dex) regimen at differing doses to study the efficacy of this regimen in patients who have failed both lenalidomide and bortezomib. Pomalidomide was given orally 2 or 4 mg daily with dexamethasone 40 mgweekly. Thirty-five patients were enrolled in each cohort. Confirmed responses in the 2-mg cohort consisted of very good partial response (VGPR) in 5 (14%), partial response (PR) in 4 (11%), minor response (MR) in 8 (23%) for an overall response rate of 49%. In the 4-mg cohort, confirmed responses consisted of complete response (CR) in 1 (3%), VGPR in 3 (9%), PR in 6 (17%), MR in 5 (14%) for an overall response rate of 43%. Overall survival at 6 months is 78% and 67% in the 2- and 4-mg cohort, respectively. Myelosuppression was the most common toxicity. This nonrandomized data suggests no advantage for 4 mg over the 2 mg daily. Pomalidomide overcomes resistance in myeloma refractory to both lenalidomide and bortezomib. This trial is registered at http://ClinicalTrials.gov, number NCT00558896.

Original languageEnglish (US)
Pages (from-to)2970-2975
Number of pages6
JournalBlood
Volume118
Issue number11
DOIs
StatePublished - Sep 15 2011

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Refractory materials
Dexamethasone
Multiple Myeloma
Toxicity
Survival
lenalidomide
Bortezomib
pomalidomide

ASJC Scopus subject areas

  • Hematology
  • Biochemistry
  • Cell Biology
  • Immunology

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Pomalidomide plus low-dose dexamethasone in myeloma refractory to both bortezomib and lenalidomide : Comparison of 2 dosing strategies in dual-refractory disease. / Lacy, Martha; Allred, Jacob B.; Gertz, Morie; Hayman, Suzanne R.; Short, Kristen Detweiler; Buadi, Francis; Dispenzieri, Angela; Kumar, Shaji K; Greipp, Philip R.; Lust, John A.; Russell, Stephen J; Dingli, David M; Zeldenrust, Steven; Fonseca, Rafael; Bergsagel, Peter Leif; Roy, Vivek; Stewart, Alexander Keith; Laumann, Kristina; Mandrekar, Sumithra J; Reeder, Craig; Rajkumar, S Vincent; Mikhael, Joseph R.

In: Blood, Vol. 118, No. 11, 15.09.2011, p. 2970-2975.

Research output: Contribution to journalArticle

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title = "Pomalidomide plus low-dose dexamethasone in myeloma refractory to both bortezomib and lenalidomide: Comparison of 2 dosing strategies in dual-refractory disease",
abstract = "Pomalidomide at doses of 2 or 4 mg/d has demonstrated excellent activity in patients with multiple myeloma (MM). We opened 2 sequential phase 2 trials using the pomalidomide with weekly dexamethasone (Pom/dex) regimen at differing doses to study the efficacy of this regimen in patients who have failed both lenalidomide and bortezomib. Pomalidomide was given orally 2 or 4 mg daily with dexamethasone 40 mgweekly. Thirty-five patients were enrolled in each cohort. Confirmed responses in the 2-mg cohort consisted of very good partial response (VGPR) in 5 (14{\%}), partial response (PR) in 4 (11{\%}), minor response (MR) in 8 (23{\%}) for an overall response rate of 49{\%}. In the 4-mg cohort, confirmed responses consisted of complete response (CR) in 1 (3{\%}), VGPR in 3 (9{\%}), PR in 6 (17{\%}), MR in 5 (14{\%}) for an overall response rate of 43{\%}. Overall survival at 6 months is 78{\%} and 67{\%} in the 2- and 4-mg cohort, respectively. Myelosuppression was the most common toxicity. This nonrandomized data suggests no advantage for 4 mg over the 2 mg daily. Pomalidomide overcomes resistance in myeloma refractory to both lenalidomide and bortezomib. This trial is registered at http://ClinicalTrials.gov, number NCT00558896.",
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AU - Lacy, Martha

AU - Allred, Jacob B.

AU - Gertz, Morie

AU - Hayman, Suzanne R.

AU - Short, Kristen Detweiler

AU - Buadi, Francis

AU - Dispenzieri, Angela

AU - Kumar, Shaji K

AU - Greipp, Philip R.

AU - Lust, John A.

AU - Russell, Stephen J

AU - Dingli, David M

AU - Zeldenrust, Steven

AU - Fonseca, Rafael

AU - Bergsagel, Peter Leif

AU - Roy, Vivek

AU - Stewart, Alexander Keith

AU - Laumann, Kristina

AU - Mandrekar, Sumithra J

AU - Reeder, Craig

AU - Rajkumar, S Vincent

AU - Mikhael, Joseph R

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N2 - Pomalidomide at doses of 2 or 4 mg/d has demonstrated excellent activity in patients with multiple myeloma (MM). We opened 2 sequential phase 2 trials using the pomalidomide with weekly dexamethasone (Pom/dex) regimen at differing doses to study the efficacy of this regimen in patients who have failed both lenalidomide and bortezomib. Pomalidomide was given orally 2 or 4 mg daily with dexamethasone 40 mgweekly. Thirty-five patients were enrolled in each cohort. Confirmed responses in the 2-mg cohort consisted of very good partial response (VGPR) in 5 (14%), partial response (PR) in 4 (11%), minor response (MR) in 8 (23%) for an overall response rate of 49%. In the 4-mg cohort, confirmed responses consisted of complete response (CR) in 1 (3%), VGPR in 3 (9%), PR in 6 (17%), MR in 5 (14%) for an overall response rate of 43%. Overall survival at 6 months is 78% and 67% in the 2- and 4-mg cohort, respectively. Myelosuppression was the most common toxicity. This nonrandomized data suggests no advantage for 4 mg over the 2 mg daily. Pomalidomide overcomes resistance in myeloma refractory to both lenalidomide and bortezomib. This trial is registered at http://ClinicalTrials.gov, number NCT00558896.

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