Scientific publications

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

May 15, 2017 | Magazine: European Journal of Haematology

Moreau P (1), Dimopoulos MA (2), Richardson PG (3), Siegel DS (4), Cavo M (5), Corradini P (6), Weisel K (7), Delforge M (8), O'Gorman P (9), Song K (10), Chen C (11), Bahlis N (12), Oriol A (13), Hansson M (14), Kaiser M (15), Anttila P (16), Raymakers R (17), Joao C (18), Cook G (19), Sternas L (20), Biyukov T (21), Slaughter A (21), Hong K (20), Herring J (20), Yu X (20), Zaki M (20), San-Miguel J (22).

Heavily pretreated patients with relapsed and refractory multiple myeloma are susceptible to treatment-related adverse events (AEs). Managing AEs is 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.

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.

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.

Pomalidomide plus low-dose dexamethasone showed an acceptable safety profile and AEs were well managed according to study protocols and established guidelines. This article is protected by copyright. All rights reserved.

CITATION  Eur J Haematol. 2017 Sep;99(3):199-206.
doi: 10.1111/ejh.12903. Epub 2017 Jun 14

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