International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab
- Conditions
- Plasma Cell Myeloma
- Interventions
- Registration Number
- NCT05669989
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Isatuximab Dexamethasone Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the participant received on the parental protocol Isatuximab Cemiplimab (SAR439684) Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the participant received on the parental protocol Isatuximab Isatuximab subcutaneous (SC) Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the participant received on the parental protocol Isatuximab Isatuximab intravenous (IV) Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the participant received on the parental protocol Isatuximab Lenalidomide Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the participant received on the parental protocol Isatuximab Pomalidomide Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the participant received on the parental protocol Isatuximab Carfilzomib Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the participant received on the parental protocol
- Primary Outcome Measures
Name Time Method Number of participants with treatment-emergent adverse events Baseline to 42 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
Washington University- Site Number : 8400001
🇺🇸Saint 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
🇧🇷Sao 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 : 7240006
🇪🇸Seville, Andalucia, 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, Navarra, Spain
Investigational Site Number : 7240003
🇪🇸Madrid, Spain
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
🇬🇷Patras, Greece
Investigational Site Number : 3800002
🇮🇹Torino, Italy
Investigational Site Number : 3920001
🇯🇵Okayama, Japan
Investigational Site Number : 4100001
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100002
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 5540002
🇳🇿Auckland, New Zealand
Investigational Site Number : 5540001
🇳🇿Wellington, New Zealand
Investigational Site Number : 6430002
🇷🇺Kirov, Russian Federation
Investigational Site Number : 6430001
🇷🇺Moscow, Russian Federation
Investigational Site Number : 7240002
🇪🇸Salamanca, Spain
Investigational Site Number : 7520004
🇸🇪Luleå, Sweden
Investigational Site Number : 1580001
🇨🇳Taichung, Taiwan