International Journal of Hematology

DOI: 10.1007/s12185-019-02757-0 Pages: 65-74

Elotuzumab plus lenalidomide and dexamethasone for newly diagnosed multiple myeloma: a randomized, open-label, phase 2 study in Japan

1. Aomori Prefectural Central Hospital, Department of Hematology

2. Ibaraki Prefectural Central Hospital, Department of Hematology

3. Osaka Saiseikai Nakatsu Hospital, Department of Hematology

4. Hematology Ohta Clinic

5. Gunma University Hospital, Department of Hematology

6. Mita Hospital, International University of Health and Welfare, Department of Lymphoma/Hematologic Malignancy Center

7. National Hospital Organization Shibukawa Medical Center, Department of Hematology

8. National Center for Global Health and Medicine Hospital, Division of Hematology, Internal Medicine

9. Tokyo Women’s Medical University, Department of Hematology

10. Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Hematology Division

11. Chiba University Hospital, Department of Hematology

12. International University of Health and Welfare, Department of Hematology, School of Medicine

13. Japanese Red Cross Medical Center, Department of Hematology

14. Iwate Medical University Hospital, Department of Clinical Oncology

15. Bristol-Myers Squibb K.K.

16. Bristol-Myers Squibb

17. National Hospital Organization Disaster Medical Center, Department of Hematology

Correspondence to:
Kohmei Kubo
Email: komei.kubo@nifty.com

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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.

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