PMID- 28504846 OWN - NLM STAT- MEDLINE DCOM- 20180502 LR - 20180502 IS - 1600-0609 (Electronic) IS - 0902-4441 (Linking) VI - 99 IP - 3 DP - 2017 Sep TI - Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis. PG - 199-206 LID - 10.1111/ejh.12903 [doi] 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 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. CI - (c) 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. FAU - Moreau, Philippe AU - Moreau P AUID- ORCID: 0000-0003-1780-8746 AD - University Hospital Hotel-Dieu, Nantes, France. FAU - Dimopoulos, Meletios A AU - Dimopoulos MA AD - National and Kapodistrian University of Athens, Athens, Greece. FAU - Richardson, Paul G AU - Richardson PG AD - Dana-Farber Cancer Institute, Boston, MA, USA. FAU - Siegel, David S AU - Siegel DS AD - John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA. FAU - Cavo, Michele AU - Cavo M AD - Bologna University School of Medicine, Bologna, Italy. FAU - Corradini, Paolo AU - Corradini P AD - University of Milano, Fondazione IRCCS Istituto Nazionale de Tumori, Milano, Italy. FAU - Weisel, Katja AU - Weisel K AD - University Hospital of Tuebingen, Tuebingen, Germany. FAU - Delforge, Michel AU - Delforge M AD - University Hospital Leuven, Leuven, Belgium. FAU - O'Gorman, Peter AU - O'Gorman P AD - Mater Misericordiae University Hospital, University College Dublin, Dublin, Ireland. FAU - Song, Kevin AU - Song K AD - Vancouver General Hospital, Vancouver, British Columbia, Canada. FAU - Chen, Christine AU - Chen C AD - Princess Margaret Hospital, Toronto, Ontario, Canada. FAU - Bahlis, Nizar AU - Bahlis N AD - Tom Baker Cancer Center, University of Calgary, Calgary, Canada. FAU - Oriol, Albert AU - Oriol A AD - Institut Catala d'Oncologia, Institut Josep Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain. FAU - Hansson, Markus AU - Hansson M AD - Skane University Hospital, Lund University, Lund, Sweden. FAU - Kaiser, Martin AU - Kaiser M AD - The Royal Marsden Hospital, Surrey, UK. FAU - Anttila, Pekka AU - Anttila P AD - Helsinki University and Helsinki University Hospital Comprehensive Cancer, Helsinki, Finland. FAU - Raymakers, Reinier AU - Raymakers R AD - University Medical Center Utrecht, Utrecht, The Netherlands. FAU - Joao, Cristina AU - Joao C AD - Hemato-Oncology Department, Champalimaud Foundation for the Unknown and Faculdade de Ciencias Medicas-NOVA University, Lisbon, Portugal. FAU - Cook, Gordon AU - Cook G AD - St James's Institute of Oncology, St James's University Hospital, Leeds, UK. FAU - Sternas, Lars AU - Sternas L AD - Celgene Corporation, Summit, NJ, USA. FAU - Biyukov, Tsvetan AU - Biyukov T AD - Celgene International Sarl, Boudry, Switzerland. FAU - Slaughter, Ana AU - Slaughter A AD - Celgene International Sarl, Boudry, Switzerland. FAU - Hong, Kevin AU - Hong K AD - Celgene Corporation, Summit, NJ, USA. FAU - Herring, Jennifer AU - Herring J AD - Celgene Corporation, Summit, NJ, USA. FAU - Yu, Xin AU - Yu X AD - Celgene Corporation, Summit, NJ, USA. FAU - Zaki, Mohamed AU - Zaki M AD - Celgene Corporation, Summit, NJ, USA. FAU - San-Miguel, Jesus AU - San-Miguel J AD - Clinica Universidad de Navarra, CIMA, IDISNA, Pamplona, Spain. LA - eng PT - Journal Article DEP - 20170614 PL - England TA - Eur J Haematol JT - European journal of haematology JID - 8703985 RN - 4Z8R6ORS6L (Thalidomide) RN - 7S5I7G3JQL (Dexamethasone) RN - D2UX06XLB5 (pomalidomide) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols/*adverse effects/therapeutic use MH - Clinical Trials as Topic MH - Combined Modality Therapy MH - Dexamethasone/administration & dosage MH - Disease Management MH - Drug Resistance, Neoplasm MH - Drug-Related Side Effects and Adverse Reactions/*diagnosis/*therapy MH - Humans MH - Middle Aged MH - Multicenter Studies as Topic MH - Multiple Myeloma/*drug therapy/*pathology MH - Neoplasm Recurrence, Local MH - Thalidomide/administration & dosage/analogs & derivatives MH - Time Factors OTO - NOTNLM OT - dexamethasone OT - pomalidomide OT - pooled analysis OT - relapsed and refractory multiple myeloma OT - safety EDAT- 2017/05/16 06:00 MHDA- 2018/05/03 06:00 CRDT- 2017/05/16 06:00 PHST- 2015/05/09 00:00 [accepted] PHST- 2017/05/16 06:00 [pubmed] PHST- 2018/05/03 06:00 [medline] PHST- 2017/05/16 06:00 [entrez] AID - 10.1111/ejh.12903 [doi] PST - ppublish SO - Eur J Haematol. 2017 Sep;99(3):199-206. doi: 10.1111/ejh.12903. Epub 2017 Jun 14.