Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone : A pooled analysis
(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.
(Less)
- author
- Moreau, Philippe
; Dimopoulos, Meletios A.
; Richardson, Paul G
; Siegel, David S.
; Cavo, Michele
; Corradini, Paolo
; Weisel, Katja C.
; Delforge, Michel
; O'Gorman, Peter
; Song, Kevin
; Chen, Christine
; Bahlis, Nizar
; Oriol, Albert
; Hansson, Markus
LU
; Kaiser, Martin
; Anttila, Pekka
; Raymakers, Reinier
; Joao, Cristina
; Cook, Gordon
; Sternas, Lars
; Biyukov, Tsvetan
; Slaughter, Ana
; Hong, Kevin
; Herring, Jennifer
; Yu, Xin
; Zaki, Mohamed H.
and San Miguel, Jesus
(Less) - organization
- publishing date
- 2017-09-01
- type
- Contribution to journal
- 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
- pmid:28504846
- wos:000408148200001
- ISSN
- 0902-4441
- DOI
- 10.1111/ejh.12903
- language
- English
- LU publication?
- yes
- id
- 9bfc4f83-7282-4815-9dcd-43e63f2ff4cf
- date added to LUP
- 2017-09-04 10:55:05
- date last changed
- 2025-02-17 22:57:04
@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 > 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}},
keywords = {{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}},
doi = {{10.1111/ejh.12903}},
volume = {{99}},
year = {{2017}},
}