Published in:
01-01-2020 | Multiple Myeloma | Original Article
Elotuzumab plus lenalidomide and dexamethasone for newly diagnosed multiple myeloma: a randomized, open-label, phase 2 study in Japan
Authors:
Kohmei Kubo, Mitsuo Hori, Kensuke Ohta, Hiroshi Handa, Kiyohiko Hatake, Morio Matsumoto, Shotaro Hagiwara, Kazuteru Ohashi, Chiaki Nakaseko, Kenshi Suzuki, Shigeki Ito, Gen Kinoshita, Suresh G. Shelat, Masafumi Miyoshi, Naoki Takezako
Published in:
International Journal of Hematology
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Issue 1/2020
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Abstract
Novel therapies are needed for patients with newly diagnosed multiple myeloma (NDMM). Elotuzumab plus lenalidomide and dexamethasone (ELd) is approved for the treatment of relapsed/refractory multiple myeloma (RRMM). This phase 2 study in Japan evaluated ELd vs lenalidomide and dexamethasone (Ld) in patients with NDMM who were ineligible for stem cell transplantation. Elotuzumab infusion was accelerated to 5 mL/min by dose 3, cycle 1, allowing most subsequent infusions to be completed within 1 h. The primary endpoint was overall response rate (ORR) in the ELd arm. Secondary endpoints were the difference in ORR between treatments, and progression-free survival (PFS). Patients were randomized to ELd (n = 40) or Ld (n = 42); median number of treatment cycles was 13 (ELd) and 12 (Ld). In the ELd arm, ORR was 88% [70% confidence interval (CI) 80–93]. The estimated difference in ORR between treatments was 13% (95% CI − 4, 30) in favor of ELd. Progression-free survival data were immature. Safety was consistent with previous findings of ELd in Japanese patients with RRMM. No infusion reactions occurred at the maximum rate of 5 mL/min, which was used in 89% of elotuzumab infusions. ELd may be an effective, well-tolerated frontline treatment for patients with NDMM ineligible for stem cell transplantation.