A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination With Pomalidomide and Low-Dose Dexamethasone Versus Pomalidomide and Low-Dose Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

Primary Objective:

To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose
dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to
pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and
refractory multiple myeloma (MM).

Secondary Objectives:

- To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group
(IMWG) criteria in each arm.

- To compare the Overall Survival (OS) between the two arms.

- To evaluate the Time To Progression (TTP) in each arm.

- To evaluate the PFS in high risk cytogenetic population in each arm.

- To evaluate the Duration of Response (DOR) in each arm.

- To evaluate the safety in both treatment arms.

- To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide.

- To evaluate the immunogenicity of isatuximab.

- To assess disease-specific and generic health-related quality of life (HRQL), disease
and treatment-related symptoms, health state utility, and health status.

主要研究目的：
相较于单用泊马度胺联合低剂量地塞米松方案，评估艾沙妥昔单抗（isatuximab）联合泊马度胺（pomalidomide）与低剂量地塞米松方案，在难治性或复发难治性多发性骨髓瘤（MM）受试者中延长无进展生存期（PFS）的获益。

次要研究目的：
- 依据国际骨髓瘤工作组（IMWG）标准，评估两组受试者的总缓解率（ORR）。
- 对比两组受试者的总生存期（OS）。
- 评估两组受试者的疾病进展时间（TTP）。
- 评估两组中高危细胞遗传学人群的无进展生存期（PFS）。
- 评估两组受试者的缓解持续时间（DOR）。
- 评估两种治疗方案的安全性。
- 明确艾沙妥昔单抗联合泊马度胺的药代动力学特征。
- 评估艾沙妥昔单抗的免疫原性。
- 评估疾病特异性与普适性健康相关生活质量（HRQL）、疾病及治疗相关症状、健康状态效用值及健康状况。