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

NCT05669989 | Active Not Recruiting Phase 2 FDA Drug

• 4 other identifiers: LTS17704U1111-1277-66352023-507180-192022-002253-26
• Study Type: interventional
• Target: 70
• Locations: 17 countries
• Sites: 37

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-emergent adverse events

  Baseline to 42 months

Study Arms (1)

Isatuximab

EXPERIMENTAL

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); Drug: Cemiplimab (SAR439684); Drug: Dexamethasone; Drug: Lenalidomide; Drug: Pomalidomide; Drug: Isatuximab subcutaneous (SC); Drug: Carfilzomib

Interventions

Cemiplimab (SAR439684) DRUG

Route of administration: IV infusion; Pharmaceutical form: Vial

Isatuximab

Dexamethasone DRUG

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

Isatuximab

Carfilzomib DRUG

Route of administration: IV infusion; Pharmaceutical form: Vial

Isatuximab

Isatuximab intravenous (IV) DRUG

Route of administration: IV infusion; Pharmaceutical form: Vial

Also known as: SARCLISA®, SAR650984

Isatuximab

Lenalidomide DRUG

Route of administration: Oral; Pharmaceutical form: Capsules

Isatuximab

Pomalidomide DRUG

Route of administration: Oral; Pharmaceutical form: Hard capsules

Isatuximab

Isatuximab subcutaneous (SC) DRUG

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

Also known as: SARCLISA®, SAR650984

Isatuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (37)

Washington University- Site Number : 8400001

St Louis, Missouri, 63110, United States

Location

Investigational Site Number : 0360006

Blacktown, New South Wales, 2148, Australia

Location

Investigational Site Number : 0360001

Saint Leonards, New South Wales, 2065, Australia

Location

Investigational Site Number : 0360003

Wollongong, New South Wales, 2500, Australia

Location

Investigational Site Number : 0360004

Melbourne, Victoria, 3065, Australia

Location

Investigational Site Number : 0360005

Melbourne, Victoria, 3084, Australia

Location

Investigational Site Number : 0360002

Richmond, Victoria, 3121, Australia

Location

Hospital Mae de Deus- Site Number : 0760003

Porto Alegre, Rio Grande do Sul, 90880-480, Brazil

Location

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP- Site Number : 0760002

São Paulo, São Paulo, 05403-010, Brazil

Location

Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760001

Rio de Janeiro, 22775-001, Brazil

Location

Investigational Site Number : 1520001

Temuco, 4780000, Chile

Location

Investigational Site Number : 1560001

Tianjin, 300020, China

Location

Investigational Site Number : 2030002

Brno, 625 00, Czechia

Location

Investigational Site Number : 2030003

Ostrava, 708 52, Czechia

Location

Investigational Site Number : 2030001

Prague, 128 08, Czechia

Location

Investigational Site Number : 2460001

Helsinki, 00029, Finland

Location

Investigational Site Number : 2500002

Nantes, 44093, France

Location

Investigational Site Number : 3000004

Athens, 106 76, Greece

Location

Investigational Site Number : 3000003

Athens, 115 28, Greece

Location

Investigational Site Number : 3000001

Pátrai, 265 04, Greece

Location

Investigational Site Number : 3800002

Torino, 10126, Italy

Location

Investigational Site Number : 3920001

Okayama, 701-1192, Japan

Location

Investigational Site Number : 5540002

Auckland, 2025, New Zealand

Location

Investigational Site Number : 5540001

Wellington, 6021, New Zealand

Location

Investigational Site Number : 6430002

Kirov, 610027, Russia

Location

Investigational Site Number : 6430001

Moscow, 125284, Russia

Location

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 03080, South Korea

Location

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, 06591, South Korea

Location

Investigational Site Number : 7240006

Seville, Andalusia, 41013, Spain

Location

Investigational Site Number : 7240004

Santander, Cantabria, 39008, Spain

Location

Investigational Site Number : 7240005

Badalona, Catalunya [Cataluña], 08916, Spain

Location

Investigational Site Number : 7241001

Madrid, Madrid, Comunidad de, 28027, Spain

Location

Investigational Site Number : 7240001

Pamplona, Navarre, 31008, Spain

Location

Investigational Site Number : 7240003

Madrid, 28041, Spain

Location

Investigational Site Number : 7240002

Salamanca, 37007, Spain

Location

Investigational Site Number : 7520004

Luleå, 971 80, Sweden

Location

Investigational Site Number : 1580001

Taichung, 404, Taiwan

Location

Related Links

• LTS17704 Plain Language Results Summary

MeSH Terms

Conditions

Multiple Myeloma

Interventions

isatuximab; cemiplimab; Dexamethasone; Lenalidomide; pomalidomide; carfilzomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 3, 2023
• Study Start: April 5, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

NZ (2); CN (1); TW (1); FI (1); US (1); CL (1); GR (3); CZ (3); FR (1); IT (1); AU (6); ES (7); JP (1); RU (2); KR (2); SE (1); BR (3)