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International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

NCT05669989 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-05-11

No results posted yet for this study

Summary

* This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study.
* This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study.
* The primary objective of the study is to assess long-term safety of isatuximab as study treatment.

Conditions

  • Plasma Cell Myeloma

Interventions

DRUG

Isatuximab intravenous (IV)

Route of administration: IV infusion; Pharmaceutical form: Vial

DRUG

Cemiplimab (SAR439684)

Route of administration: IV infusion; Pharmaceutical form: Vial

DRUG

Dexamethasone

Route of administration: Oral or IV infusion; Pharmaceutical form: Tablets/single use vial

DRUG

Lenalidomide

Route of administration: Oral; Pharmaceutical form: Capsules

DRUG

Pomalidomide

Route of administration: Oral; Pharmaceutical form: Hard capsules

DRUG

Isatuximab subcutaneous (SC)

Route of administration: SC injection with the investigational isatuximab injector device; Pharmaceutical form: Vial

DRUG

Carfilzomib

Route of administration: IV infusion; Pharmaceutical form: Vial

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-05
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Chile
  • China
  • Czechia
  • Finland
  • France
  • Greece
  • Italy
  • Japan
  • New Zealand
  • Russia
  • South Korea
  • Spain
  • Sweden
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05669989 on ClinicalTrials.gov