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

Moreau, Philippe; Dimopoulos, Meletios A.; Richardson, Paul G; Siegel, David S.; Cavo, Michele; Corradini, Paolo; Weisel, Katja C.; Delforge, Michel; O'Gorman, Peter and Song, Kevin, et al. (2017) In European Journal of Haematology 99(3). p.199-206
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... (More)

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.

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publication status
published
subject
keywords
dexamethasone, pomalidomide, pooled analysis, relapsed and refractory multiple myeloma, safety
in
European Journal of Haematology
volume
99
issue
3
pages
8 pages
publisher
Wiley-Blackwell
external identifiers
  • scopus:85027834548
  • pmid:28504846
  • wos:000408148200001
ISSN
0902-4441
DOI
10.1111/ejh.12903
language
English
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yes
id
9bfc4f83-7282-4815-9dcd-43e63f2ff4cf
date added to LUP
2017-09-04 10:55:05
date last changed
2017-09-18 11:44:16
@article{9bfc4f83-7282-4815-9dcd-43e63f2ff4cf,
  abstract     = {<p>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 &gt; 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.</p>},
  author       = {Moreau, Philippe and Dimopoulos, Meletios A. and Richardson, Paul G and Siegel, David S. and Cavo, Michele and Corradini, Paolo and Weisel, Katja C. and Delforge, Michel and O'Gorman, Peter and Song, Kevin and Chen, Christine and Bahlis, Nizar and Oriol, Albert and Hansson, Markus and Kaiser, Martin and Anttila, Pekka and Raymakers, Reinier and Joao, Cristina and Cook, Gordon and Sternas, Lars and Biyukov, Tsvetan and Slaughter, Ana and Hong, Kevin and Herring, Jennifer and Yu, Xin and Zaki, Mohamed H. and San Miguel, Jesus},
  issn         = {0902-4441},
  keyword      = {dexamethasone,pomalidomide,pooled analysis,relapsed and refractory multiple myeloma,safety},
  language     = {eng},
  month        = {09},
  number       = {3},
  pages        = {199--206},
  publisher    = {Wiley-Blackwell},
  series       = {European Journal of Haematology},
  title        = {Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone : A pooled analysis},
  url          = {http://dx.doi.org/10.1111/ejh.12903},
  volume       = {99},
  year         = {2017},
}