CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 307 enrolled
Drug / intervention
Isatuximab +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02990338
NCT02990338Phase 3Completed
CompareCT.gov

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

Sanofi·interventional·Posted Dec 13, 2016·Updated Jan 17, 2025

In Brief

A Phase 3 clinical trial evaluating Isatuximab, Pomalidomide, and 1 other intervention for Plasma Cell Myeloma. Completed, enrolled 307 participants across 111 sites in 24 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlasma Cell Myeloma
CountriesAustralia, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 13, 2016
Enrollment StartDec 22, 2016
Primary CompletionNov 22, 2018
Study CompletionNov 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.6 years ago

Interventions

Isatuximabdrug

Pharmaceutical form: solution for infusion Route of administration: intravenous

Pomalidomidedrug

Pharmaceutical form: capsule Route of administration: oral

Dexamethasonedrug

Pharmaceutical form: tablets or solution for infusion Route of administration: oral or intravenous