TerminatedPhase 1

A Study to Investigate Safety and Efficacy With SAR445514 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and Relapsed/Refractory Light-chain Amyloidosis (RRLCA)

Stopped: Early discontinuation based on sponsor decision not driven by any safety concerns; phase 2 was not initiated.

Australia, Belgium, Czechia32 participantsStarted 2023-05-15

Plain-language summary

This is a first-in-human (FIH) Phase 1/Phase 2 study for evaluating SAR445514 in monotherapy in participants with relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory light chain amyloidosis (RRLCA). The study will comprise 3 parts: A dose escalation phase (Part 1) in RRMM participants (Part 1a) that will evaluate several doses administered to determine 2 doses that will be tested in the dose optimization part. A dose escalation will also be done in RRLCA participants (Part 1b) but started sequentially after the end of the dose escalation in RRMM participants. This dose escalation will evaluate the 2 doses planned to be used in dose optimization in RRMM, to ensure those doses are safe also for RRLCA participants. A dose optimization phase (Part 2) that will be evaluating 2 doses determined from Part 1 to determine the preliminary recommended Phase 2 dose (pRP2D) and schedule for SAR445514 in RRMM. A dose expansion phase (Part 3) that will evaluate the preliminary efficacy of pRP2D and schedule for SAR445514 in RRMM (Part 3a) and RRLCA (Part 3b). Approximately 111 participants will be enrolled and treated by study intervention and separated as such: Part 1a: Approximately 30 to 40 participants Part 1b: Approximately 6 to 12 participants Part 2: Approximately 30 participants Part 3a: Approximately 15 participants Part 3b: Approximately 14 participants

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

. N-terminal prohormone of brain natriuretic peptide (NT-proBNP) \>8500 ng/mL
. New York Heart Association (NYHA) classification III or IV heart failure
. Heart failure that, in the opinion of the Investigator, is not primarily related to LCA cardiomyopathy (including, but not limited to, ischemic heart disease, uncorrected valvular disease, infections)
. Prior event (history) in the last 6 months of acute coronary syndrome, myocardial infarction or unstable angina as well as participants who during the last 6 months experienced a percutaneous cardiac intervention with stent and/or a coronary artery bypass
. Hospitalization in the last 4 weeks prior to treatment related to a cardiovascular event
. Participants with prior history of arrhythmia and/or cardiac conduction disorders for which a pacemaker or an implantable cardioverter defibrillator (ICD) is required but has not been placed. This includes, but may not be limited to, sustained ventricular tachycardia, association of an atrioventricular, or sinoatrial nodal dysfunction

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

Dose escalation (part 1a - RRMM) Presence of dose limiting toxicities (DLT)

Timeframe: Cycle 1 - 4 weeks per cycle

Dose escalation (part 1a - RRMM) Percentage of participants experiencing treatment-emergent adverse events (TEAEs)

Timeframe: From Baseline to end of follow-up (approx. 15 months)

Dose optimization (part 2 - RRMM) Overall response rate (ORR)

Timeframe: Cycles 1 to 4 - 4 weeks per cycle

Dose escalation (part 1b - RRLCA) Presence of dose limiting toxicities (DLT) at cycle 1

Timeframe: Cycle 1 - 4 weeks per cycle

Dose escalation (part 1b - RRLCA) Percentage of participants experiencing treatment-emergent adverse events (TEAEs)

Timeframe: From baseline to end of follow-up (approx. 15 months)

Dose expansion (part 3 - RRMM) Overall response rate (ORR)

Timeframe: Cycles 1 to 4 - 4 weeks per cycle

Trial details

NCT IDNCT05839626

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-26

View on ClinicalTrials.gov More Relapsed/Refractory Multiple Myeloma trials

Plain-language summary

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

. N-terminal prohormone of brain natriuretic peptide (NT-proBNP) \>8500 ng/mL
. New York Heart Association (NYHA) classification III or IV heart failure
. Heart failure that, in the opinion of the Investigator, is not primarily related to LCA cardiomyopathy (including, but not limited to, ischemic heart disease, uncorrected valvular disease, infections)
. Prior event (history) in the last 6 months of acute coronary syndrome, myocardial infarction or unstable angina as well as participants who during the last 6 months experienced a percutaneous cardiac intervention with stent and/or a coronary artery bypass
. Hospitalization in the last 4 weeks prior to treatment related to a cardiovascular event
. Participants with prior history of arrhythmia and/or cardiac conduction disorders for which a pacemaker or an implantable cardioverter defibrillator (ICD) is required but has not been placed. This includes, but may not be limited to, sustained ventricular tachycardia, association of an atrioventricular, or sinoatrial nodal dysfunction

What they're measuring

Dose escalation (part 1a - RRMM) Presence of dose limiting toxicities (DLT)

Timeframe: Cycle 1 - 4 weeks per cycle

Dose escalation (part 1a - RRMM) Percentage of participants experiencing treatment-emergent adverse events (TEAEs)

Timeframe: From Baseline to end of follow-up (approx. 15 months)

Dose optimization (part 2 - RRMM) Overall response rate (ORR)

Timeframe: Cycles 1 to 4 - 4 weeks per cycle

Dose escalation (part 1b - RRLCA) Presence of dose limiting toxicities (DLT) at cycle 1

Timeframe: Cycle 1 - 4 weeks per cycle

Dose escalation (part 1b - RRLCA) Percentage of participants experiencing treatment-emergent adverse events (TEAEs)

Timeframe: From baseline to end of follow-up (approx. 15 months)

Dose expansion (part 3 - RRMM) Overall response rate (ORR)

Timeframe: Cycles 1 to 4 - 4 weeks per cycle