Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis

Research output: Contribution to journalArticle

Abstract

Objectives: Heavily pretreated patients with relapsed and refractory multiple myeloma are susceptible to treatment-related adverse events (AEs). Managing AEs are important to ensure patients continue therapy long enough to receive the best clinical benefit. Data from the MM-002, MM-003, and MM-010 trials were pooled to further characterize the safety profile of pomalidomide plus low-dose dexamethasone and AE management. Methods: This analysis included 1088 patients who received ≥ 2 prior therapies, including lenalidomide and bortezomib, and progressed ≤ 60 days of last therapy. Patients received 28-day cycles of pomalidomide 4 mg/day on days 1-21 and low-dose dexamethasone 40 mg (20 mg if aged > 75 years) weekly until disease progression or unacceptable toxicity. Thromboprophylaxis was required. Results: The most common grade 3/4 AEs were neutropenia (56.2%), anemia (32.3%), and thrombocytopenia (25.8%), which occurred within the first few cycles of treatment. Grade 3/4 infections occurred in 33.7% patients, of whom 13.9% had pneumonia, and 40.3% had neutropenia. Pomalidomide dose reductions or interruptions were reported in 24.2% and 66.0% of patients, respectively. AEs were managed by dose modifications and/or supportive care. Conclusions: Pomalidomide plus low-dose dexamethasone showed an acceptable safety profile, and AEs were well managed according to study protocols and established guidelines.

Details

Authors
  • Philippe Moreau
  • Meletios A. Dimopoulos
  • Paul G Richardson
  • David S. Siegel
  • Michele Cavo
  • Paolo Corradini
  • Katja C. Weisel
  • Michel Delforge
  • Peter O'Gorman
  • Kevin Song
  • Christine Chen
  • Nizar Bahlis
  • Albert Oriol
  • Martin Kaiser
  • Pekka Anttila
  • Reinier Raymakers
  • Cristina Joao
  • Gordon Cook
  • Lars Sternas
  • Tsvetan Biyukov
  • Ana Slaughter
  • Kevin Hong
  • Jennifer Herring
  • Xin Yu
  • Mohamed H. Zaki
  • Jesus San Miguel
Organisations
External organisations
  • Nantes University Hospital
  • National and Kapodistrian University of Athens
  • Dana-Farber Cancer Institute
  • Hackensack University Medical Center
  • St. Orsola-Malpighi University Hospital
  • University of Milan
  • University Hospital of Tubingen
  • University Hospitals Leuven
  • Mater Misericordiae University Hospital
  • Vancouver General Hospital
  • Princess Margaret Hospital University of Toronto
  • University of Calgary
  • Hospital Universitari Germans Trias i Pujol
  • The Royal Marsden Hospital
  • Helsinki University Central Hospital
  • University Medical Center Utrecht
  • New University of Lisbon
  • St James's University Hospital
  • Celgene Corporation
  • Celgene International Sàrl
  • University of Navarra
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cancer and Oncology

Keywords

  • dexamethasone, pomalidomide, pooled analysis, relapsed and refractory multiple myeloma, safety
Original languageEnglish
Pages (from-to)199-206
Number of pages8
JournalEuropean Journal of Haematology
Volume99
Issue number3
Publication statusPublished - 2017 Sep 1
Publication categoryResearch
Peer-reviewedYes