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

NCT ID: NCT05669989

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-05
• Study Completion Date: 2026-11-30

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.

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.

Conditions

Plasma Cell Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Isatuximab

Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the participant received on the parental protocol

Group Type: EXPERIMENTAL

Isatuximab intravenous (IV)

Intervention Type: DRUG

Route of administration: IV infusion; Pharmaceutical form: Vial

Cemiplimab (SAR439684)

Intervention Type: DRUG

Route of administration: IV infusion; Pharmaceutical form: Vial

Dexamethasone

Intervention Type: DRUG

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

Lenalidomide

Intervention Type: DRUG

Route of administration: Oral; Pharmaceutical form: Capsules

Pomalidomide

Intervention Type: DRUG

Route of administration: Oral; Pharmaceutical form: Hard capsules

Isatuximab subcutaneous (SC)

Intervention Type: DRUG

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

Carfilzomib

Intervention Type: DRUG

Route of administration: IV infusion; Pharmaceutical form: Vial

Interventions

Isatuximab intravenous (IV)

Route of administration: IV infusion; Pharmaceutical form: Vial

Intervention Type: DRUG

Cemiplimab (SAR439684)

Route of administration: IV infusion; Pharmaceutical form: Vial

Intervention Type: DRUG

Dexamethasone

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

Intervention Type: DRUG

Lenalidomide

Route of administration: Oral; Pharmaceutical form: Capsules

Intervention Type: DRUG

Pomalidomide

Route of administration: Oral; Pharmaceutical form: Hard capsules

Intervention Type: DRUG

Isatuximab subcutaneous (SC)

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

Intervention Type: DRUG

Carfilzomib

Route of administration: IV infusion; Pharmaceutical form: Vial

Intervention Type: DRUG

Other Intervention Names

SARCLISA®, SAR650984; SARCLISA®, SAR650984

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Washington University- Site Number : 8400001

St Louis, Missouri, United States

Investigational Site Number : 0360006

Blacktown, New South Wales, Australia

Investigational Site Number : 0360001

Saint Leonards, New South Wales, Australia

Investigational Site Number : 0360003

Wollongong, New South Wales, Australia

Investigational Site Number : 0360004

Melbourne, Victoria, Australia

Investigational Site Number : 0360005

Melbourne, Victoria, Australia

Investigational Site Number : 0360002

Richmond, Victoria, Australia

Hospital Mae de Deus- Site Number : 0760003

Porto Alegre, Rio Grande do Sul, Brazil

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

São Paulo, São Paulo, Brazil

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

Rio de Janeiro, , Brazil

Investigational Site Number : 1520001

Temuco, , Chile

Investigational Site Number : 1560001

Tianjin, , China

Investigational Site Number : 2030002

Brno, , Czechia

Investigational Site Number : 2030003

Ostrava, , Czechia

Investigational Site Number : 2030001

Prague, , Czechia

Investigational Site Number : 2460001

Helsinki, , Finland

Investigational Site Number : 2500002

Nantes, , France

Investigational Site Number : 3000004

Athens, , Greece

Investigational Site Number : 3000003

Athens, , Greece

Investigational Site Number : 3000001

Pátrai, , Greece

Investigational Site Number : 3800002

Torino, , Italy

Investigational Site Number : 3920001

Okayama, , Japan

Investigational Site Number : 5540002

Auckland, , New Zealand

Investigational Site Number : 5540001

Wellington, , New Zealand

Investigational Site Number : 6430002

Kirov, , Russia

Investigational Site Number : 6430001

Moscow, , Russia

Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 7240006

Seville, Andalusia, Spain

Investigational Site Number : 7240004

Santander, Cantabria, Spain

Investigational Site Number : 7240005

Badalona, Catalunya [Cataluña], Spain

Investigational Site Number : 7241001

Madrid, Madrid, Comunidad de, Spain

Investigational Site Number : 7240001

Pamplona, Navarre, Spain

Investigational Site Number : 7240003

Madrid, , Spain

Investigational Site Number : 7240002

Salamanca, , Spain

Investigational Site Number : 7520004

Luleå, , Sweden

Investigational Site Number : 1580001

Taichung, , Taiwan

Countries

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

Other Identifiers

U1111-1277-6635

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-507180-19

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022-002253-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LTS17704

Identifier Type: -

Identifier Source: org_study_id