PMID- 28860655 OWN - NLM STAT- MEDLINE DCOM- 20190208 LR - 20190614 IS - 1476-5551 (Electronic) IS - 0887-6924 (Linking) VI - 32 IP - 3 DP - 2018 Mar TI - Pomalidomide-dexamethasone in refractory multiple myeloma: long-term follow-up of a multi-cohort phase II clinical trial. PG - 719-728 LID - 10.1038/leu.2017.258 [doi] AB - Despite therapeutic advances, multiple myeloma remains incurable, with limited options for patients with refractory disease. We conducted a large, multi-cohort clinical trial testing various doses and treatment schedules of pomalidomide and dexamethasone (Pom/dex) in patients with refractory multiple myeloma. Overall, 345 patients were enrolled to six cohorts based on number and type of prior lines of therapy, pomalidomide dose and schedule. Median prior lines of therapy were three with near universal prior exposure to proteasome inhibitors and/or immunomodulatory drugs. A confirmed response rate of 35% was noted for all cohorts (range 23-65%) with higher responses in cohorts with fewer prior lines of therapy. Median time to confirmed response was ⩽2 months and the longest progression-free survival and overall survival seen in any cohort were 13.1 and 47.9 months, respectively. Observed adverse reactions were as expected, with myelosuppression and fatigue being the most common hematologic and non-hematologic adverse events (AEs), respectively. Longer durations of treatment and response, higher response rates and fewer AEs were noted with the 2 mg pomalidomide dose. This is the longest follow-up data for Pom/dex in refractory multiple myeloma and will help shape the real-world utilization of this regimen. FAU - Ailawadhi, S AU - Ailawadhi S AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Jacksonville, FL, USA. FAU - Mikhael, J R AU - Mikhael JR AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Rochester, MN, USA. FAU - LaPlant, B R AU - LaPlant BR AD - Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA. FAU - Laumann, K M AU - Laumann KM AD - Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA. FAU - Kumar, S AU - Kumar S AUID- ORCID: 0000-0001-5392-9284 AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Phoenix, AZ, USA. FAU - Roy, V AU - Roy V AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Jacksonville, FL, USA. FAU - Dingli, D AU - Dingli D AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Phoenix, AZ, USA. FAU - Bergsagel, P L AU - Bergsagel PL AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Rochester, MN, USA. FAU - Buadi, F K AU - Buadi FK AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Phoenix, AZ, USA. FAU - Rajkumar, S V AU - Rajkumar SV AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Phoenix, AZ, USA. FAU - Fonseca, R AU - Fonseca R AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Rochester, MN, USA. FAU - Gertz, M A AU - Gertz MA AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Phoenix, AZ, USA. FAU - Kapoor, P AU - Kapoor P AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Phoenix, AZ, USA. FAU - Sher, T AU - Sher T AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Jacksonville, FL, USA. FAU - Hayman, S R AU - Hayman SR AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Phoenix, AZ, USA. FAU - Stewart, A K AU - Stewart AK AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Rochester, MN, USA. FAU - Dispenzieri, A AU - Dispenzieri A AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Phoenix, AZ, USA. FAU - Kyle, R A AU - Kyle RA AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Phoenix, AZ, USA. FAU - Gonsalves, W I AU - Gonsalves WI AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Phoenix, AZ, USA. FAU - Reeder, C B AU - Reeder CB AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Rochester, MN, USA. FAU - Lin, Y AU - Lin Y AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Phoenix, AZ, USA. FAU - Go, R S AU - Go RS AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Phoenix, AZ, USA. FAU - Leung, N AU - Leung N AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Phoenix, AZ, USA. FAU - Kourelis, T AU - Kourelis T AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Phoenix, AZ, USA. FAU - Lust, J A AU - Lust JA AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Phoenix, AZ, USA. FAU - Russell, S J AU - Russell SJ AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Rochester, MN, USA. FAU - Chanan-Khan, A A AU - Chanan-Khan AA AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Jacksonville, FL, USA. FAU - Lacy, M Q AU - Lacy MQ AD - Division of Hematology and Medical Oncology, Department of Medicine, Mayo Clinic, Phoenix, AZ, USA. LA - eng GR - P50 CA186781/CA/NCI NIH HHS/United States PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, N.I.H., Extramural DEP - 20170901 PL - England TA - Leukemia JT - Leukemia JID - 8704895 RN - 0 (Biomarkers, Tumor) 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 - Biomarkers, Tumor MH - Dexamethasone/administration & dosage MH - *Drug Resistance, Neoplasm MH - Female MH - Follow-Up Studies MH - Humans MH - Male MH - Middle Aged MH - Multiple Myeloma/diagnosis/*drug therapy/genetics/mortality MH - Retreatment MH - Survival Analysis MH - Thalidomide/administration & dosage/analogs & derivatives MH - Treatment Outcome EDAT- 2017/09/02 06:00 MHDA- 2019/02/09 06:00 CRDT- 2017/09/02 06:00 PHST- 2017/02/09 00:00 [received] PHST- 2017/06/07 00:00 [revised] PHST- 2017/07/05 00:00 [accepted] PHST- 2017/09/02 06:00 [pubmed] PHST- 2019/02/09 06:00 [medline] PHST- 2017/09/02 06:00 [entrez] AID - leu2017258 [pii] AID - 10.1038/leu.2017.258 [doi] PST - ppublish SO - Leukemia. 2018 Mar;32(3):719-728. doi: 10.1038/leu.2017.258. Epub 2017 Sep 1.