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Relapsed/Refractory Multiple MyelomaPhase 1NCT05839626

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

A Phase 1 study testing SAR445514 in people with Relapsed/Refractory Multiple Myeloma and Amyloid Light-chain Amyloidosis, run by Sanofi at 16 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SAR445514
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
16 sitesin 7 countries
Study dates
15 May 2023to 26 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have a documented diagnosis of multiple myeloma (Part 1a, 2, and 3a) or light chain amyloidosis (Part 1b and 3b).
  • Participants with RRMM (Part 1, 2, and 3a)
  • Participants with measurable disease for RRMM
  • Participants with MM must have received at least 2 prior lines of therapy which must include at least 2 consecutive cycles of a second or third generation immunomodulator, steroid, proteasome inhibitor and anti-CD38 monoclonal antibody (MoAb).
  • Participants must have documented evidence of progressive disease (PD), as per IMWG 2016 criteria.
  • Participants with RR LCA (Part 1b and 3b) must have received at least 1 prior line of treatment comprising at least 1 proteasome inhibitor.
Show all 11Show fewer
  • Participants with measurable disease according to ISA 2012.
  • Participants must have documented evidence of progressive disease (PD), as per ISA 2012 criteria.
  • One or more organ impacted by amyloidosis as per National comprehensive cancer network (NCCN) guidelines.
  • For dose escalation, body weight within 40 to 120 kg
  • Capable of giving signed informed consent

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • Medical conditions
  • Primary refractory MM defined as participants who never achieved at least a minimal response with any treatment during the disease course
  • Second primary malignancy
  • Participants with RRMM (Part 1a, 2, and 3a)
  • For MM participants, primary systemic LCA and plasma cell leukemia
Show all 44Show fewer
  • For MM participants, congestive heart failure (New York Heart Association [NYHA]) Grade ≥II; cardiomyopathy, active ischemia, or any other uncontrolled cardiac condition
  • Participants with RR LCA (Part 1b and 3b)
  • For LCA participants, evidence of clinically significant cardiovascular condition, defined as one or more of the following:
  • 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
  • For LCA participants, a systolic blood pressure <100 mmHg or a diastolic blood pressure <55 mmHg.
  • For LCA participants: previous or current diagnosis of symptomatic MM, including the presence of lytic bone disease, plasmacytomas, ≥60% plasma cells in the BM, or hypercalcemia.
  • All participants
  • Uncontrolled infection within 14 days prior to study treatment.
  • Known acquired immunodeficiency syndrome-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment or active hepatitis A (defined as positive hepatitis A antigen or positive IgM); HIV serology at screening will be tested for participants in countries where it is required by local regulations.
  • Uncontrolled or active hepatitis B virus (HBV) infection: participants with positive B surface antigen (HBsAg) and/or HBV deoxyribonucleic acid (DNA)
  • Active hepatitis C virus (HCV) infection: positive HCV ribonucleic acid (RNA) and negative anti-HCV.
  • Prior/concomitant therapy
  • Any anti-MM drug treatment within 14 days before study treatment
  • Prior allogenic hematopoietic stem cell (HSC) transplant with active graft-versus-host disease (GvHD) (GvHD any grade and/or being under immunosuppressive treatment within the last 2 months prior to first IMP).
  • Any major procedure within 14 days before the initiation of the study treatment
  • Administration of an anti-CD38 monoclonal antibody (isatuximab or daratumumab) less than 90 days prior to the first administration of study treatment.
  • Administration of an anti-BCMA agent (including, but not limited to, CAR T-cells, TCEs, antibody drug conjugate) less than 21 days prior to the administration of study treatment.
  • Unresolved toxicities from prior anticancer therapy, defined as not having resolved to CTCAE Version 5.0 Grade 1, at the exception of residual Grade 2 peripheral neurotoxicity related to bortezomib and/or thalidomide and considered as stable.
  • Participants with a contraindication to dexamethasone.
  • Prior/concurrent clinical study experience
  • Received any other investigational drugs or prohibited therapy for this study within 28 days or 5 half-lives from study treatment, whichever is shorter
  • Diagnostic assessments
  • Hemoglobin <8 g/dL (5.0 mmol/L)
  • Platelets <50 × 10^9/L (not permissible to transfuse a participant within 1 week prior to the screening platelet count to reach this level).
  • Absolute neutrophil count (ANC) <1000 μL (1 × 10^9/L).
  • Creatinine clearance <30 mL/min (Modification of Diet in Renal Disease Formula).
  • Total bilirubin >1.5 × upper limit of normal (ULN) (unless the subject has documented Gilbert syndrome in which case direct bilirubin should not be >2.5 × ULN).
  • Aspartate aminotransferase (AST/SGOT) or Alanine aminotransferase (ALT/SGPT) >2.5 × ULN.
  • Participants with Grade 3 or 4 hypercalcemia (corrected serum calcium of >12.5 mg/dL; >3.1 mmol/L; ionized calcium >1.6 mmol/L; or requiring hospitalization) will not be eligible unless participants recover to Grade 2 or less under anti-hypercalcemia treatment.
  • Other exclusions
  • 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
  • Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.

Trial locations and contacts

16 sites in 7 countries.

16 sites in 7 countries

Belgium4 sites

  • Institut Jules Bordet_Site Number : 0560002

    Anderlecht, 1070

  • Het Ziekenhuisnetwerk Antwerpen vzw - ZNA Middelheim_Site Number : 0560001-2

    Antwerp, 2020

  • Het Ziekenhuisnetwerk Antwerpen vzw - ZNA Cadix_Site Number : 0560001-1

    Antwerp, 2030

  • Investigational Site Number : 0560001

    Antwerp, 2060

Other trials in Belgium

Spain3 sites

  • Institut Catala d´oncologia - Badalona_Site Number : 7240002

    Badalona, Catalonia, 08916

  • HOSPITAL CLINIC i PROVINCIAL BARCELONA_Site Number : 7240003

    Barcelona, 08036

  • Hospital Universitario Marqués de Valdecilla_Site Number : 7240001

    Santander, Cantabria, 39008

Other trials in Spain

United Kingdom3 sites

  • Investigational Site Number : 8260003

    Birmingham, B15 2TH

  • Investigational Site Number : 8260002

    London, NW1 2BU

  • Investigational Site Number : 8260001

    Manchester, M20 4BX

Other trials in United Kingdom

Australia2 sites

  • Investigational Site Number : 0360002

    Richmond, Victoria, 3121

  • Investigational Site Number : 0360001

    Wollongong, New South Wales, 2500

Other trials in Australia

Czechia2 sites

  • Investigational Site Number : 2030002

    Brno, 625 00

  • Investigational Site Number : 2030001

    Ostrava, 708 52

Other trials in Czechia

Hungary1 site

  • Investigational Site Number : 3480001

    Budapest, 1085

Other trials in Hungary

Italy1 site

  • Investigational Site Number : 3800001

    Rozzano, Lombardy, 20089

Other trials in Italy

About this study

Official title: First-in-human, Open-label Phase 1/2 Study to Investigate Safety and Efficacy of SAR445514, an NKcell Engager (NKCE) Targeting B-cell Maturation Antigen (BCMA) in Monotherapy in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) and in Relapsed/Refractory Light-chain Amyloidosis (RRLCA)

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:

Read more

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

Read the detailed description

The duration of the study for a participant will include A screening period: up to 28 days prior day 1 of cycle 1 (C1D1) A treatment period: enrolled participants will receive administration of 4 weeks cycles of SAR445514 subcutaneously.

The End of treatment visit will occur 30 days (+/- 7 days) from last investigational medicinal product (IMP) administration or prior initiation of further therapy, whichever comes first.

The follow-up period will continue until death, participant's request to discontinue study, final Overall Survival analysis or upon cancellation of survival follow-up at the discretion of the Sponsor at any timepoint.

Being tested
SAR445514
Medical subject headings
Multiple Myeloma, Immunoglobulin Light-chain Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR445514Drug

    Powder for solution for injection. Sub Cutaneous administration.

Study groups in NCT05839626
Study groupRoleWhat they receive
SAR445514 RRMM Dose escalation phase (Part 1a)ExperimentalSAR445514 will be administered to participants with relapsed/refractory multiple myeloma (RRMM) using subcutaneous route (SC)
Receives: Drug: SAR445514
SAR445514 RRLCA Dose escalation phase (part 1b)ExperimentalSAR445514 will be administered to participants with relapsed/refractory light chain amyloidosis (RRLCA)) using subcutaneous route (SC)
Receives: Drug: SAR445514
SAR445514 Dose level A (part 2)ExperimentalSAR445514 will be administered to participants with relapsed/refractory multiple myeloma (RRMM) using subcutaneous route (SC)
Receives: Drug: SAR445514
SAR445514 Dose level B (part 2)ExperimentalSAR445514 will be administered to participants with relapsed/refractory multiple myeloma (RRMM) using subcutaneous route (SC)
Receives: Drug: SAR445514
SAR445514 RRMM Dose expansion (part 3a)ExperimentalSAR445514 will be administered to participants with relapsed/refractory multiple myeloma (RRMM) using subcutaneous route (SC)
Receives: Drug: SAR445514
SAR445514 RRLCA Dose expansion (part 3b)ExperimentalSAR445514 will be administered to participants with relapsed/refractory light chain amyloidosis (RRLCA) using subcutaneous route (SC)
Receives: Drug: SAR445514

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    DLTs will be defined using NCI CTCAE version 5.0 or ASTCT criteria for CRS or ICANS.

    Measured: Cycle 1 - 4 weeks per cycle

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

    Presence of TEAEs, SAEs, and lab abnormalities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading

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

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

    ORR is defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the 2016 International Myeloma Working Group (IMWG) criteria, after the last participant is treated for at least 4 cycles or prematurely discontinued.

    Measured: Cycles 1 to 4 - 4 weeks per cycle

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

    Measured: Cycle 1 - 4 weeks per cycle

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

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

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

    ORR is defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the 2016 International Myeloma Working Group (IMWG) criteria.

    Measured: Cycles 1 to 4 - 4 weeks per cycle

  7. Dose expansion (part 3-RRLCA) Hematological response (HR)

    HR is defined as the proportion of participants with sCR, CR, VGPR, and PR according to the European society of hematology/International society of hematology working group guidelines.

    Measured: Cycles 1 to 4 - 4 weeks per cycle

Secondary outcomes (27)

  1. Dose escalation (part 1 - RRMM) Overall response rate (ORR)

    ORR defined as the proportion of participants with sCR, CR, VGPR, and PR according to the 2016 IMWG criteria.

    Measured: Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)

  2. Dose optimization (part 2 - RRMM) Presence of dose limiting toxicities (DLT)

    Measured: Cycles 1 to 4 - 4 weeks per cycle

  3. Dose optimization (part 2 - RRMM) Percentage of participants experiencing treatment-emergent adverse events (TEAEs)

    Treatment-emergent adverse events (AEs) are defined as AEs that develop, worsen, or become serious during the treatment period. The treatment period is defined as the time from first dose of study treatment up to 30 days after last dose of study treatment.

    Measured: From first dose of study treatment up to 30 days after last dose of study treatment (approx. 1 year with cycle of 28 days)

  4. Dose optimization & expansion (Part 2 & Part 3a - RRMM) Very Good Partial Response (VGPR) or Better Rate

    VGPR is defined as the proportion of participants with sCR, CR, and VGPR according to the 2016 IMWG criteria.

    Measured: Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)

  5. Dose optimization & expansion (Part 2 & Part 3a - RRMM) Duration of response (DOR)

    DOR is defined as the time from the date of the first response to the date of the first occurrence of progressive disease (PD as determined by the investigator or death from any cause, whichever happens first. DOR is determined only for participants who have achieved a response (PR or better).

    Measured: Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)

  6. Dose optimization & expansion (Part 2 & Part 3a - RRMM) Time to first response (TT1R)

    TT1R is defined as the time from the date of the first response to the date of the first occurrence of progressive disease (PD as determined by the investigator or death from any cause, whichever happens first. DOR is determined only for participants who have achieved a response (PR or better).

    Measured: Cycle 1 to first progressive disease or end of treatment whichever comes first (approx. 1 year with cycle of 28 days)

  7. Dose optimization & expansion (Part 2 & Part 3a -RRMM) Time to best response (TTBR)

    TTBR is defined as the time from the first administration of the IMP to the date of first occurrence of best overall response (PR or better that is subsequently confirmed.

    Measured: Cycle 1 to first progressive disease or end of treatment whichever comes first (approx. 1 year with cycle of 28 days)

  8. Dose optimization & expansion (Part 2 & Part 3a - RRMM) Progression free survival (PFS)

    PFS is defined as the time from the date of the first administration of the IMP to the date of first documentation of progressive disease or the date of death from any cause, whichever comes first. Responses will be determined according to IMWG criteria. Progression based on paraprotein will be confirmed based on two consecutive assessments.

    Measured: Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)

  9. Dose optimization & expansion (Part 2 & Part 3a - RRMM) Overall survival (OS)

    OS is defined as the time from the date of the first administration of the IMP to death from any cause

    Measured: Cycle 1 to end of follow-up or death (approx. 15 months with cycle of 28 days)

  10. Dose optimization & expansion (Part 2 & Part 3a - RRMM) Clinical benefit rate (CBR)

    CBR is the rate of participants with confirmed CR or PR at any time or stable disease (SD) of at least 6 months from the first IMP administration determined by the Investigator per IMWG 2016 criteria.

    Measured: Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)

  11. Dose escalation (part 1b - RRLCA) Overall Hematological Response (OHR)

    OHR is defined as the proportion of participants with CR, VGPR, and PR according to the International Society of Amyloidosis guidelines (ISA 2012).

    Measured: Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)

  12. Dose extension (part 3b - RRLCA) Hematological complete response rate (HCR).

    HCR is defined as the proportion of participants with complete response according to the ISA 2012.

    Measured: Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)

  13. Dose extension (part 3b - RRLCA) Hematological very good partial response rate or better (HVGPR)

    HVGPR defined as proportion of participants with very good partial response and CR as per ISA 2012 criteria

    Measured: Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)

  14. Dose expansion (part 3b - RRLCA) Overall survival (OS)

    OS is defined as the time from the date of study entry to death from any cause.

    Measured: Cycle 1 to death or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)

  15. Dose expansion (part 3b - RRLCA) Progression-Free Survival (PFS)

    PFS is defined as time from the time from the first administration of the IMP to any of the following: hematological progression, major organ progression (cardiac, kidney or liver) according to ISA 2012 criteria or death by any cause.

    Measured: Cycle 1 to first progressive disease (organ or hematological) or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)

  16. Dose expansion (part 3b - RRLCA) Time to first hematological response (TT1HR)

    TT1HR is defined as the time from the first administration of the IMP to the date of first hematological response (PR or better) that is subsequently confirmed.

    Measured: Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)

  17. Dose expansion (part 3b - RRLCA) Duration of hematological response (DOHR)

    DOHR is defined as time from the time from the first administration of the IMP to any of the following: hematological progression, major organ progression (cardiac, kidney or liver) according to ISA 2012 criteria or death by any cause.

    Measured: Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)

  18. Dose expansion (Part 3 - RRMM & RRLCA) Percentage of participants experiencing treatment-emergent adverse events (TEAEs)

    Treatment-emergent adverse events (AEs) are defined as AEs that develop, worsen, or become serious during the treatment-emergent period.

    Measured: From first dose of study treatment up to 30 days after last dose of study treatment (approx. 15 months with cycle of 28 days)

  19. Incidence rate of infusion associated reactions (IARs)

    Measured: From cycle 1 to end of treatment (approx. 1 year with cycle of 28 days)

  20. Incidence rate of injection site reactions (ISR)

    Measured: From cycle 1 to end of treatment (approx. 1 year with cycle of 28 days)

  21. Incidence of laboratory abnormalities

    Measured: From cycle 1 to end of follow-up (approx. 15 months with cycle of 28 days)

  22. Assessment of pharmacokinetics (PK) parameter of SAR445514: Ctrough

    Measured: From cycle 1 to end of treatment (approx. 1 year with cycle of 28 days)

  23. Assessment of pharmacokinetics (PK) parameter of SAR445514: AUClast

    Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to time of the last concentration observed above the lower limit of quantification (ie, Clast)

    Measured: From cycle 1 to end of treatment (approx. 1 year with cycle of 28 days)

  24. Assessment of pharmacokinetics (PK) parameter of SAR445514: Cmax

    Maximum observed concentration

    Measured: From cycle 1 to end of treatment (approx. 1 year with cycle of 28 days)

  25. Assessment of pharmacokinetics (PK) parameter of SAR445514: Tmax

    First time to reach Cmax

    Measured: From cycle 1 to end of treatment (approx. 1 year with cycle of 28 days)

  26. Incidence of anti-drug antibody (ADA) against SAR445514

    Measured: From cycle 1 to end of treatment (approx. 1 year with cycle of 28 days)

  27. Dose extension (Part 3 - RRMM & RRLCA) Minimum Residual Disease (MRD) negativity rate

    MRD status in participants with response of VGPR or better

    Measured: Cycle 1 to first progressive disease or end of follow-up whichever comes first (approx. 15 months with cycle of 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start15 May 2023
  3. Primary completion26 May 2025
  4. Study completion26 May 2025

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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05839626
Sponsor's protocol ID
TCD17710
Other IDs
U1111-1279-2985, 2022-502057-33-00
Status last verified
May 2026
First submitted
31 Mar 2023
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAR445514 in people with Relapsed/Refractory Multiple Myeloma and Amyloid Light-chain Amyloidosis, run by Sanofi at 16 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Belgium, Spain, United Kingdom, Australia, Czechia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Early discontinuation based on sponsor decision not driven by any safety concerns; phase 2 was not initiated.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose escalation (part 1a - RRMM) Presence of dose limiting toxicities (DLT) (time frame: Cycle 1 - 4 weeks per cycle). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05839626.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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