SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients

Summary

Primary Objectives: * To determine the maximum tolerated dose of SAR650984 (isatuximab) with lenalidomide and dexamethasone (LD) in patients with relapsed or refractory multiple myeloma. * Expansion Phase Only: To further evaluate preliminary evidence of antitumor activity (objective response rate \[ORR\]) of SAR650984 (isatuximab) in combination with LD using International Myeloma Working Group (IMWG) criteria. Secondary Objectives: * To evaluate the safety, including immunogenicity, of SAR650984 (isatuximab) in combination with LD in relapsed or refractory multiple myeloma. The severity, frequency and incidence of all toxicities will be assessed. * To evaluate the pharmacokinetics (PK) of SAR650984 (isatuximab) when administered in combination with LD and the PK of lenalidomide in combination with SAR650984 and dexamethasone. * To assess the relationship between clinical (adverse event \[AE\] and/or tumor response) effects and pharmacologic parameters (PK/pharmacodynamics), and/or biologic (correlative laboratory) results. * For the dose expansion phase, estimate the activity (ORR) using IMWG defined response criteria of SAR650984 (isatuximab) plus LD. * To describe progression-free survival (PFS) in patients treated with this combination.

Timeline

Start

2013-02-06

Primary completion

2023-06-20

Completion

2023-06-20

Publications

• Sun H, Martin TG, Marra J, Kong D, Keats J, Mace S, Chiron M, Wolf JL, Venstrom JM, Rajalingam R. Individualized genetic makeup that controls natural killer cell function influences the efficacy of isatuximab immunotherapy in patients with multiple myeloma. J Immunother Cancer. 2021 Jul;9(7):e002958. doi: 10.1136/jitc-2021-002958.
• Martin T, Baz R, Benson DM, Lendvai N, Wolf J, Munster P, Lesokhin AM, Wack C, Charpentier E, Campana F, Vij R. A phase 1b study of isatuximab plus lenalidomide and dexamethasone for relapsed/refractory multiple myeloma. Blood. 2017 Jun 22;129(25):3294-3303. doi: 10.1182/blood-2016-09-740787. Epub 2017 May 8.

Drugs

Indications