NCT02990338

Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The duration of the study for the participants included a period for screening of up to 21 days (or up to 28 days for women who can become pregnant). Participants continued study treatment until disease progression, unacceptable adverse reaction, participants' wish or other reason of discontinuation. During follow-up, participants who discontinued the study treatment due to progression of the disease were followed every 3 months (12 weeks) for survival (or until cut-off date), and participants who discontinued the study treatment prior to documentation of disease progression were followed-up every 4 weeks until disease progression, and then every 3 months (12 weeks) for survival (or until cut-off date).

Conditions

• Plasma Cell Myeloma

Interventions

Type	Name	Description
DRUG	Isatuximab	Pharmaceutical form: solution for infusion Route of administration: intravenous
DRUG	Pomalidomide	Pharmaceutical form: capsule Route of administration: oral
DRUG	Dexamethasone	Pharmaceutical form: tablets or solution for infusion Route of administration: oral or intravenous

Timeline

• Start date: 2016-12-22
• Primary completion: 2018-11-22
• Completion: 2023-11-01
• First posted: 2016-12-13
• Last updated: 2025-01-17
• Results posted: 2019-12-06

Locations

111 sites across 24 countries: United States, Australia, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Japan, New Zealand, Norway, Poland, Portugal, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study