- 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.
- 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
- To assess the relationship between clinical (adverse event [AE] and/or tumor response)
effects and pharmacologic parameters (PK/pharmacodynamics), and/or biologic (correlative
- 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.