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 mg weekly. 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.

• Authors: Martha Q Lacy, Jacob B Allred, Morie A Gertz, Suzanne R Hayman, Kristen Detweiler Short, Francis Buadi, Angela Dispenzieri, Shaji Kumar, Philip R Greipp, John A Lust, Stephen J Russell, David Dingli, Steven Zeldenrust, Rafael Fonseca, P Leif Bergsagel, Vivek Roy, A Keith Stewart, Kristina Laumann, Sumithra J Mandrekar, Craig Reeder, S Vincent Rajkumar, Joseph R Mikhael
• Journal: Blood (Blood) Vol. 118 Issue 11 Pg. 2970-5 (Sep 15 2011) ISSN: 1528-0020 [Electronic] United States
• PMID: 21690557 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Boronic Acids
• Pyrazines
• Thalidomide
• Bortezomib
• Dexamethasone
• pomalidomide
• Lenalidomide

Topics

• Administration, Oral
• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Boronic Acids (therapeutic use)
• Bortezomib
• Dexamethasone (administration & dosage, adverse effects)
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Drug Resistance, Neoplasm (drug effects)
• Female
• Humans
• Lenalidomide
• Male
• Middle Aged
• Multiple Myeloma (drug therapy, mortality)
• Pyrazines (therapeutic use)
• Survival Analysis
• Thalidomide (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Treatment Failure
• Treatment Outcome