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

May 7, 2026 updated by: Sanofi

International, Multi-center, Open-label, Treatment Extension Study in Patients With Multiple Myeloma Who Are Still Benefitting From Isatuximab-based Therapy Following Completion of a Phase 1, 2, or 3 Parental Study

  • 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants can continue the treatment until disease progression, unacceptable adverse events, participant wish to discontinue study treatment, study treatment is commercially available and reimbursed in participant's country, or for any other reason, whichever comes first. The overall study duration will be of approximately 42 months.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Investigational Site Number : 0360006
      • Saint Leonards, New South Wales, Australia, 2065
        • Investigational Site Number : 0360001
      • Wollongong, New South Wales, Australia, 2500
        • Investigational Site Number : 0360003
    • Victoria
      • Melbourne, Victoria, Australia, 3065
        • Investigational Site Number : 0360004
      • Melbourne, Victoria, Australia, 3084
        • Investigational Site Number : 0360005
      • Richmond, Victoria, Australia, 3121
        • Investigational Site Number : 0360002
  • Brazil
      • Rio de Janeiro, Brazil, 22775-001
        • Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760001
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90880-480
        • Hospital Mae de Deus- Site Number : 0760003
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05403-010
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP- Site Number : 0760002
  • Chile
      • Temuco, Chile, 4780000
        • Investigational Site Number : 1520001
  • China
      • Tianjin, China, 300020
        • Investigational Site Number : 1560001
  • Czechia
      • Brno, Czechia, 625 00
        • Investigational Site Number : 2030002
      • Ostrava, Czechia, 708 52
        • Investigational Site Number : 2030003
      • Prague, Czechia, 128 08
        • Investigational Site Number : 2030001
  • Finland
      • Helsinki, Finland, 00029
        • Investigational Site Number : 2460001
  • France
      • Nantes, France, 44093
        • Investigational Site Number : 2500002
  • Greece
      • Athens, Greece, 115 28
        • Investigational Site Number : 3000003
      • Athens, Greece, 106 76
        • Investigational Site Number : 3000004
      • Pátrai, Greece, 265 04
        • Investigational Site Number : 3000001
  • Italy
      • Torino, Italy, 10126
        • Investigational Site Number : 3800002
  • Japan
      • Okayama, Japan, 701-1192
        • Investigational Site Number : 3920001
  • New Zealand
      • Auckland, New Zealand, 2025
        • Investigational Site Number : 5540002
      • Wellington, New Zealand, 6021
        • Investigational Site Number : 5540001
  • Russia
      • Kirov, Russia, 610027
        • Investigational Site Number : 6430002
      • Moscow, Russia, 125284
        • Investigational Site Number : 6430001
  • South Korea
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, South Korea, 03080
        • Investigational Site Number : 4100001
      • Seoul, Seoul-teukbyeolsi, South Korea, 06591
        • Investigational Site Number : 4100002
  • Spain
      • Madrid, Spain, 28041
        • Investigational Site Number : 7240003
      • Salamanca, Spain, 37007
        • Investigational Site Number : 7240002
    • Andalusia
      • Seville, Andalusia, Spain, 41013
        • Investigational Site Number : 7240006
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Investigational Site Number : 7240004
    • Catalunya [Cataluña]
      • Badalona, Catalunya [Cataluña], Spain, 08916
        • Investigational Site Number : 7240005
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28027
        • Investigational Site Number : 7241001
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Investigational Site Number : 7240001
  • Sweden
      • Luleå, Sweden, 971 80
        • Investigational Site Number : 7520004
  • Taiwan
      • Taichung, Taiwan, 404
        • Investigational Site Number : 1580001
  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University- Site Number : 8400001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant must be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the informed consent.
  • Participants of a parental Phase 1, 2, or 3 clinical study assessing isatuximab monotherapy or in a combination regimen with all the study objectives completed.
  • Participants still receiving isatuximab at the time of the parental study closure, who are continuing to benefit from isatuximab as monotherapy or in combination, as determined by the treating physician, and who meet the criteria to initiate a subsequent cycle of therapy as described in the parental study protocol. A participant not receiving isatuximab at the end of the parental study who does not have access locally to the ongoing treatment may also be included.
  • Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants; no sperm donation for male participants.
  • Capable of giving signed informed consent.

Exclusion Criteria:

  • Participant has evidence of progressive disease during or at the time of the parental study closure.
  • Participant has not recovered to ≤Grade 2 from nonhematologic AEs (as per NCI CTCAE v5.0) related to any anticancer therapy received prior to signing informed consent on the extension study.
  • As the latest line of treatment participant received an antimyeloma therapy other than the isatuximab-based therapy in the parental study before the first IMP in this study.
  • Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
  • Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
  • Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.
  • Any country-related specific regulation that would prevent the participant from entering the study.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Isatuximab
Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the participant received on the parental protocol
Drug: Isatuximab intravenous (IV)
Route of administration: IV infusion; Pharmaceutical form: Vial
Other Names:
  • SARCLISA®, SAR650984
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
Other Names:
  • SARCLISA®, SAR650984
Drug: Carfilzomib
Route of administration: IV infusion; Pharmaceutical form: Vial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-emergent adverse events
Time Frame: Baseline to 42 months
Baseline to 42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2023

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

December 20, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Actual)

January 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTS17704
  • U1111-1277-6635 (Registry Identifier: ICTRP)
  • 2022-002253-26 (EudraCT Number)
  • 2023-507180-19 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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