Overall survival of relapsed and refractory multiple myeloma patients after adjusting for crossover in the MM-003 trial for pomalidomide plus low-dose dexamethasone.

Abstract

In the phase III MM-003 trial, pomalidomide plus low-dose dexamethasone (POM+LoDEX) improved overall survival (OS) versus high-dose dexamethasone (HiDEX) in 455 patients with relapsed and refractory multiple myeloma (RRMM) after treatment with bortezomib and lenalidomide. Here, a two-stage Weibull method was used to adjust for the crossover of patients in the HiDEX arm to pomalidomide-based therapy. The adjusted difference in median OS between patients in the POM+LoDEX and HiDEX arms was 7·0 months (12·7 vs. 5·7 months, respectively). These findings provide important evidence for understanding the clinical efficacy of pomalidomide on OS benefits seen in RRMM patients.

• Authors: Gareth Morgan, Antonio Palumbo, Sujith Dhanasiri, Dawn Lee, Katja Weisel, Thierry Facon, Michel Delforge, Albert Oriol, Mohamed Zaki, Xin Yu, Lars Sternas, Christian Jacques, Ron Akehurst, Fritz Offner, Meletios A Dimopoulos
• Journal: British journal of haematology (Br J Haematol) Vol. 168 Issue 6 Pg. 820-3 (Mar 2015) ISSN: 1365-2141 [Electronic] England
• PMID: 25403264 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 John Wiley & Sons Ltd.

Chemical References

• Thalidomide
• Dexamethasone
• pomalidomide

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Bias
• Cross-Over Studies
• Dexamethasone (administration & dosage)
• Dose-Response Relationship, Drug
• Drug Resistance, Neoplasm
• Female
• Humans
• Kaplan-Meier Estimate
• Male
• Multiple Myeloma (drug therapy)
• Recurrence
• Retrospective Studies
• Salvage Therapy (methods)
• Thalidomide (administration & dosage, analogs & derivatives)