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Phase 2 dose-expansion study (PX-171-006) of carfilzomib, lenalidomide, and low-dose dexamethasone in relapsed or progressive multiple myeloma.

Abstract
We previously reported a phase 1b dose-escalation study of carfilzomib, lenalidomide, and low-dose dexamethasone (CRd) in relapsed or progressive multiple myeloma where the maximum planned dose (MPD) was carfilzomib 20 mg/m2 days 1 and 2 of cycle 1 and 27 mg/m2 days 8, 9, 15, 16, and thereafter; lenalidomide 25 mg days 1 to 21; and dexamethasone 40 mg once weekly on 28-day cycles. Herein, we present results from the phase 2 dose expansion at the MPD, focusing on the 52 patients enrolled in the MPD cohort. Median follow-up was 24.4 months. In the MPD cohort, overall response rate (ORR) was 76.9% with median time to response of 0.95 month (range, 0.5-4.6) and duration of response (DOR) of 22.1 months. Median progression-free survival was 15.4 months. ORR was 69.2% in bortezomib-refractory patients and 69.6% in lenalidomide-refractory patients with median DOR of 22.1 and 10.8 months, respectively. A median of 9.5 (range, 1-45) carfilzomib cycles were started with 7.7% of patients requiring carfilzomib dose reductions and 19.2% discontinuing CRd due to adverse events (AEs). Grade 3/4 AEs included lymphopenia (48.1%), neutropenia (32.7%), thrombocytopenia (19.2%), and anemia (19.2%). CRd at the MPD was well tolerated with robust, rapid, and durable responses.
AuthorsMichael Wang, Tom Martin, William Bensinger, Melissa Alsina, David S Siegel, Edward Kavalerchik, Mei Huang, Robert Z Orlowski, Ruben Niesvizky
JournalBlood (Blood) Vol. 122 Issue 18 Pg. 3122-8 (Oct 31 2013) ISSN: 1528-0020 [Electronic] United States
PMID24014245 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
Chemical References
  • Oligopeptides
  • Thalidomide
  • carfilzomib
  • Dexamethasone
  • lenalidomide
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
  • Dexamethasone (administration & dosage, adverse effects)
  • Diarrhea (chemically induced)
  • Disease Progression
  • Disease-Free Survival
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Fatigue (chemically induced)
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Lymphopenia (chemically induced)
  • Male
  • Middle Aged
  • Multiple Myeloma (drug therapy, pathology)
  • Neoplasm Recurrence, Local
  • Neutropenia (chemically induced)
  • Oligopeptides (administration & dosage, adverse effects)
  • Remission Induction
  • Thalidomide (administration & dosage, adverse effects, analogs & derivatives)
  • Treatment Outcome

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