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

PHASE2RECRUITING

* 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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-04-05

Primary completion: 2026-11-30

Study completion finish: 2026-11-30

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT05669989

Intervention or treatment

DRUG: Isatuximab intravenous (IV)

DRUG: Cemiplimab (SAR439684)

DRUG: Dexamethasone

DRUG: Lenalidomide

DRUG: Pomalidomide

DRUG: Isatuximab subcutaneous (SC)

DRUG: Carfilzomib

Conditions

• Plasma Cell Myeloma

Condition: Plasma Cell Myeloma
DRUG: Isatuximab intravenous (IV) and other drugs
Richmond, Victoria, Australia and more
Sponsor: Sanofi

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Investigational Site Number : 0360002

Research sites nearby

Select from list below to view details:

Investigational Site Number : 0360002
Richmond, Victoria, Australia
Investigational Site Number : 0360001
St Leonards, New South Wales, Australia
Investigational Site Number : 0360003
Wollongong, New South Wales, Australia
Investigational Site Number : 0360004
Fitzroy, Victoria, Australia

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?

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

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Number of participants with treatment-emergent adverse events	Not Specified	Baseline to 42 months

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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