Multiple Myeloma Clinical Trial

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

Summary

This is a multi-center, open-label, Phase 2 treatment extension study in patients with multiple myeloma who are still benefitting from relapsed-multiple-myeloma/" >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.

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Full 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.

View Eligibility Criteria

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 patient 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 is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT05669989

Recruitment Status:

Recruiting

Sponsor:

Sanofi

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There are 23 Locations for this study

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Washington University School of Medicine Site Number : 8400001
Saint Louis Missouri, 63110, United States
Investigational Site Number : 0360001
St Leonards New South Wales, 2065, Australia
Investigational Site Number : 0360003
Wollongong New South Wales, 2500, Australia
Investigational Site Number : 0360004
Fitzroy Victoria, 3065, Australia
Investigational Site Number : 0360002
Richmond Victoria, 3121, Australia
Instituto COI de Educacao e Pesquisa Site Number : 0760001
Rio De Janeiro , 22775, Brazil
Investigational Site Number : 1520001
Temuco , 48008, Chile
Investigational Site Number : 1560001
Tianjin , 30002, China
Investigational Site Number : 2030001
Praha 2 , 12808, Czechia
Investigational Site Number : 2460001
Helsinki , 00029, Finland
Investigational Site Number : 2500002
Nantes , 44093, France
Investigational Site Number : 3000001
Patra , 26504, Greece
Investigational Site Number : 3800002
Torino , 10126, Italy
Investigational Site Number : 3920001
Okayama-shi Okayama, 701-1, Japan
Investigational Site Number : 4100001
Seoul Seoul-teukbyeolsi, 03080, Korea, Republic of
Investigational Site Number : 6430001
Moscow , 12528, Russian Federation
Investigational Site Number : 7240004
Santander Cantabria, 39008, Spain
Investigational Site Number : 7241001
Madrid Madrid, Comunidad De, 28027, Spain
Investigational Site Number : 7240001
Pamplona Navarra, 31008, Spain
Investigational Site Number : 7240003
Madrid , 28041, Spain
Investigational Site Number : 7240002
Salamanca , 37007, Spain
Investigational Site Number : 7520004
Luleå , 97180, Sweden
Investigational Site Number : 1580001
Taichung , 40447, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT05669989

Recruitment Status:

Recruiting

Sponsor:


Sanofi

How clear is this clinincal trial information?

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