Patients non-eligible for transplant

Japanese study of elotuzumab plus lenalidomide/dexamethasone in NDMM patients

The MM Hub is delighted to report on the 59th American Society of Hematology (ASH) Annual Meeting in Atlanta, GA.  On Sunday 10 December 2017 an oral abstract session took place entitled: Session: 653. Myeloma: Therapy, excluding Transplantation: Upfront Therapy for Multiple Myeloma: Induction and Maintenance. In this session, Di. Mitsuo Hori from the Ibaraki Prefectural Central Hospital, Ibaraki, Japan, presented the findings of a phase II study. The title of the talk (Abstract 434) was: Elotuzumab Plus Lenalidomide/Dexamethasone (ELd) Vs Ld in Patients with Newly Diagnosed Multiple Myeloma: Phase 2, Randomized, Open-Label Study in Japan. This article is based on the pre-published abstract.

The study was designed to test the effects of elotuzumab with lenalidomide plus dexamethasone in comparison with lenalidomide and dexamethasone alone, in patients with Newly Diagnosed Multiple Myeloma (NDMM).  Elotuzumab has shown efficacy in Relapsed Refractory MM (RRMM), but this is the first trial testing efficacy in NDMM.

Key Findings:
  • Patients (pts), n = 82 total
    • Elotuzumab, lenalidomide, dexamethasone (ELd) = 40 pts
    • Lenalidomide, dexamethasone (Ld) = 42 pts
  • Median Age = 72 years (ELd) and 73 years (Ld)
  • Clinical Response Results
    • CR: 3% ELd vs 5% Ld
    • VGPR: 38% ELd vs 21% Ld
    • PR: 43% ELd vs 45% Ld
    • Progressive Disease: 0% ELd vs 2% Ld
    • ORR: 88% ELd vs 74% Ld
  • Most common adverse events (AEs) (ELd vs Ld): constipation (43% vs 31%), pyrexia (35% vs 7%), rash (28% vs 36%), diarrhea (28% vs 21%), nasopharyngitis (25% vs 26%), dysgeusia (23% vs 19%), malaise (23% vs 2%), peripheral edema (20% vs 14%), neutropenia (20% vs 14%), leukopenia (20% vs 7%), and back pain (18% vs 21%)
  • Most common grade 3-4 AEs (ELd vs Ld): neutropenia (10% vs 7%) and leukopenia (15% vs 0%)

While data for PFS and OS are not yet available, ELd did show improved ORR when compared to Ld therapy.  ELd had a comparable safety profile, which makes this therapeutic option attractive for further study in patients with NDMM. 

References
  1. N. Takezako et al. Elotuzumab Plus Lenalidomide/Dexamethasone (ELd) Vs Ld in Patients with Newly Diagnosed Multiple Myeloma: Phase 2, Randomized, Open-Label Study in Japan. #Abstract 434. 59th ASH Annual Meeting and Exposition, Atlanta, GA.
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