RecruitingPhase 1/2

Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

United States, Australia, France258 participantsStarted 2021-01-25

Plain-language summary

The purpose of this umbrella study is to evaluate isatuximab when combined with novel agents with or without dexamethasone in participants with relapsed or refractory myeloma. Substudy 01 is the control Substudy. Substudies 02, 03, and 06 are controlled experimental substudies. Substudies 04 and 05 are independent experimental substudies.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

Malabsorption syndrome or any condition that can significantly impact the absorption of pomalidomide.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

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

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

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

Trial details

NCT IDNCT04643002

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09-13

Contact for this trial

Trial Transparency email recommended (Toll free number for US & Canada)

800-633-1610 contact-us@sanofi.com

View on ClinicalTrials.gov More Plasma Cell Myeloma Refractory trials

Plain-language summary

What they're measuring

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

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

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

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

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

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