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

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Publication Date
2017-09Author
Moreau, P
Dimopoulos, MA
Richardson, PG
Siegel, DS
Cavo, M
Corradini, P
Weisel, K
Delforge, M
O'Gorman, P
Song, K
Chen, C
Bahlis, N
Oriol, A
Hansson, M
Kaiser, M
Anttila, P
Raymakers, R
Joao, C
Cook, G
Sternas, L
Biyukov, T
Slaughter, A
Hong, K
Herring, J
Yu, X
Zaki, M
San-Miguel, J
Type
Journal Article
Metadata
Show full item recordAbstract
<h4>Objectives</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>Pomalidomide plus low-dose dexamethasone showed an acceptable safety profile, and AEs were well managed according to study protocols and established guidelines.
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Subject
Humans
Multiple Myeloma
Neoplasm Recurrence, Local
Thalidomide
Dexamethasone
Antineoplastic Combined Chemotherapy Protocols
Combined Modality Therapy
Drug Resistance, Neoplasm
Time Factors
Adult
Aged
Aged, 80 and over
Middle Aged
Disease Management
Clinical Trials as Topic
Multicenter Studies as Topic
Drug-Related Side Effects and Adverse Reactions
Research team
Myeloma Group
Language
eng
Date accepted
2015-05-09
License start date
2017-09
Citation
European journal of haematology, 2017, 99 (3), pp. 199 - 206