Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis
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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; Delforge, Michel; O'Gorman, Peter; Song, Kevin; Chen, Christine; Bahlis, Nizar; Oriol, Albert; Hansson, Markus; Kaiser, Martin; Anttila, Pekka; Raymakers, Reinier; Joao, Cristina; Cook, Gordon; Sternas, Lars; Biyukov, Tsvetan; Slaughter, Ana; Hong, Kevin; Herring, Jennifer; Yu, Xin; Zaki, Mohamed; San-Miguel, Jesus.
in: EUR J HAEMATOL, Jahrgang 99, Nr. 3, 09.2017, S. 199-206.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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T1 - Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis
AU - Moreau, Philippe
AU - Dimopoulos, Meletios A
AU - Richardson, Paul G
AU - Siegel, David S
AU - Cavo, Michele
AU - Corradini, Paolo
AU - Weisel, Katja
AU - Delforge, Michel
AU - O'Gorman, Peter
AU - Song, Kevin
AU - Chen, Christine
AU - Bahlis, Nizar
AU - Oriol, Albert
AU - Hansson, Markus
AU - Kaiser, Martin
AU - Anttila, Pekka
AU - Raymakers, Reinier
AU - Joao, Cristina
AU - Cook, Gordon
AU - Sternas, Lars
AU - Biyukov, Tsvetan
AU - Slaughter, Ana
AU - Hong, Kevin
AU - Herring, Jennifer
AU - Yu, Xin
AU - Zaki, Mohamed
AU - San-Miguel, Jesus
N1 - © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
PY - 2017/9
Y1 - 2017/9
N2 - 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.
AB - 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.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Clinical Trials as Topic
KW - Combined Modality Therapy
KW - Dexamethasone
KW - Disease Management
KW - Drug Resistance, Neoplasm
KW - Drug-Related Side Effects and Adverse Reactions
KW - Humans
KW - Middle Aged
KW - Multicenter Studies as Topic
KW - Multiple Myeloma
KW - Neoplasm Recurrence, Local
KW - Thalidomide
KW - Time Factors
KW - Journal Article
U2 - 10.1111/ejh.12903
DO - 10.1111/ejh.12903
M3 - SCORING: Journal article
C2 - 28504846
VL - 99
SP - 199
EP - 206
JO - EUR J HAEMATOL
JF - EUR J HAEMATOL
SN - 0902-4441
IS - 3
ER -