Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

DRUG

Isatuximab

Pharmaceutical form: Concentrated solution for intravenous infusion; Route of administration: Intravenous infusion

DRUG

Dexamethasone

Pharmaceutical form: Tablet; Route of administration: Oral

DRUG

Pomalidomide

Pharmaceutical form: Capsule; Route of administration: Oral

DRUG

Belantamab mafodotin

Pharmaceutical form: Solution for infusion; Route of administration: Intravenous

DRUG

Pegenzileukin

Pharmaceutical form: Solution for infusion; Route of administration: Intravenous

DRUG

SAR439459

Pharmaceutical form: Solution for injection; Route of administration: Intravenous

DRUG

Belumosudil

Pharmaceutical form: tablet; route of administration: oral

DRUG

Evorpacept

Pharmaceutical form: Solution for infusion; Route of administration: Intravenous

Part 1 (dose finding, experimental substudies): Determination of recommended dose of novel agents in combination with isatuximab

Time frame: Through the end of cycle 1 (approximately 6 weeks)

Determination or confirmation of the dose will be based on: safety and tolerability in terms of TEAEs/SAEs, dose-limiting toxicity occurrence, and laboratory parameters available information on PK (if appropriate) and biomarkers.

Part 2 (expansion, controlled experimental substudies): VGPR Rate (Rate of Very Good Partial Response Rate or Better)

Time frame: Up to approximately 28 months after the First patient in or scheduled assessment

VGPR or better rate is defined as the percentage of participants with a VGPR or better as defined by the 2016 IMWG response criteria, assessed by Investigator based on central laboratory values and local imaging.

Part 2 (expansion, independent experimental substudies): Overall Response Rate (ORR) in independent experimental substudies

Time frame: Up to approximately 28 months after the First patient in or scheduled assessment

ORR, defined as the proportion of participants with stringent complete response (sCR), complete response (CR), VGPR, or partial response (PR), according to the 2016 IMWG criteria assessed by Investigator based on central laboratory values and local imaging.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.