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New cocktail of cancer drugs aims to outsmart relapsed myeloma

NCT ID NCT04643002

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This umbrella trial tests the drug isatuximab (Sarclisa) combined with several newer agents, with or without dexamethasone, in adults whose multiple myeloma has returned or stopped responding to at least two prior treatments. About 258 participants will be assigned to different substudies to find the safest and most effective combinations. The goal is to improve response rates and offer more options for this hard-to-treat blood cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
isatuximab (Sarclisa) combined with dexamethasone, pomalidomide, belantamab mafodotin, or pegenzileukin
What this could lead to
If successful, this could offer new combination treatment options for people with multiple myeloma that has stopped responding to standard therapies.
What could go wrong
This is an early-phase trial with small groups testing different drug combos. Many experimental combinations may not work better than existing ones, and side effects could be serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 258 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2021

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant must be 18 years of age inclusive or older. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Participants with relapsed or refractory MM who have received at least 2 prior lines of therapy for MM, including PIs and IMiDs (eg, Induction regimen with autologous stem cell transplant followed by maintenance is considered one line). * RRMM with measurable disease: * Serum M protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or * Urine M protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/or * Serum free light chain (sFLC) MM without measurable M protein in serum or urine per previous criteria (serum Ig free light chain ≥10 mg/dL and abnormal serum Ig kappa lambda free light chain ratio \<0.26 or \>1.65). * Men or woman or childbearing potential should agree to use contraception. * Substudy 01, 06: Anti-CD38 therapy naïve or prior exposure to such drugs with a wash out of at least 12 months after the last dose. "Exposure" is defined as at least 2 cycles of therapy. * Substudies 02, 03: Anti-CD38 therapy naïve or prior exposure to such drugs without being refractory but with a wash out of at least 6 months after the last dose. "Refractory" is defined as progressing within 60 days of last dose of anti-CD38 targeting therapy. * Substudy 04: Anti-CD38 and anti-B cell maturation antigen (BCMA) therapy (if available) prior exposed participants with RRMM. For anti-CD38, "Exposure" is defined as at least 2 cycles of therapy. For anti-BCMA therapy if available, exposure is defined by at least 2 cycles of therapy. * Substudy 05: Participants with RRMM with at least 2 cycles of prior exposure to anti-CD38 therapy. For participants to whom BCMA targeted therapy is available (ie, approved in their region and can be reimbursed), at least 2 cycles of prior exposure to a BCMA targeted agent is mandatory. Exclusion Criteria: * Primary systemic amyloid light chain amyloidosis, plasma cell leukemia, monoclonal gammopathy of undetermined significance, or smoldering myeloma. * Uncontrolled infection within 14 days prior to first study intervention administration. * Clinically significant cardiac (including valvular) or vascular disease within 3 months prior to first study intervention administration., eg, myocardial infarction, unstable angina, coronary (eg, coronary artery bypass graft, percutaneous coronary intervention) or peripheral artery revascularization, left ventricular ejection fraction \<40%, heart failure New York Heart Association Classes III and IV, stroke, transient ischemic attack, pulmonary embolism, other thromboembolic event, or cardiac arrhythmia (Grade 3 or higher by NCI CTCAE Version 5.0). * Known acquired immunodeficiency syndrome-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment or active hepatitis A. * Uncontrolled or active hepatitis B virus (HBV) infection. * Active hepatitis C virus (HCV) infection. * Any of the following within 3 months prior to first study intervention administration: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease. * Second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma, unless they are successfully treated with curative intent for more than 3 years before first study intervention administration. * Any anti-MM drug treatment within 14 days before first study intervention administration, including dexamethasone. * Participants with a contraindication to treatment. * Vaccination with a live vaccine 4 weeks before the start of the study. * Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted. * Hemoglobin \<8 g/dL. * Platelets \<50 × 10\^9/L. * Absolute neutrophil count \<1.0 × 10\^9/L. * Creatinine clearance \<30 mL/min/1.73m2. * Total bilirubin \>1.5 × ULN, except for known Gilbert syndrome in which direct bilirubin should be ≤2.5 × ULN. * Aspartate aminotransferase and/or alanine aminotransferase \>3 × ULN. * Patients with grade 3 or 4 hypercalcemia. Substudy 01: -Malabsorption syndrome or any condition that can significantly impact the absorption of pomalidomide. Substudy 02: * History of resected/ablated basal or squamous cell carcinoma (SCC) of the skin or carcinoma in situ of the cervix, or other local tumors, even if considered cured by local treatment. * Therapeutic doses of anticoagulants or antiplatelet agents within 7 days prior to the first dose of SAR439459. * Prothrombin time or INR \>1.5 × upper limit of normal (ULN). Substudy 03: * Current corneal epithelial disease except mild punctate keratopathy. * Patients who have received prior therapy with belantamab mafodotin. Substudy 04: * Central nervous system or leptomeningeal disease. * Medical history of seizure. * Participants currently receiving hepatically metabolized narrow therapeutic index drugs (eg, digoxin, warfarin) if cannot be closely monitored. * Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs), except controlled by replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc). The following are not exclusionary: vitiligo, childhood asthma that has resolved, psoriasis that does not require systemic treatment. * Prior allogeneic hematopoietic stem cell transplant (allo-HSCT). Substudy 05: \- Participant unable to swallow tablets. Substudy 06: * History of active autoimmune disorders. * History of autoimmune hemolytic anemia or autoimmune. thrombocytopenia. * Active graft versus host disease (GVHD) or ongoing immunosuppression for GVHD. * Prior allogenic hematopoietic stem cell transplant (allo-HSCT). * Patient with chronic active EBV infection. * Patients with known history of HLH. * Hemoglobin \< 9 g/dL. * Prior therapy with any anti-CD47 or anti signal regulatory protein alpha agent. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma refractory plasma cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Plasma cell myeloma refractory

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    25 sites in 10 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Investigational Site Number : 0360001

    RECRUITING

    Richmond, Victoria, 3121, Australia

  • Investigational Site Number : 0360002

    RECRUITING

    Melbourne, Victoria, 3065, Australia

  • Investigational Site Number : 0360006

    RECRUITING

    Wollongong, New South Wales, 2500, Australia

  • Investigational Site Number : 2500001

    RECRUITING

    Nantes, 44093, France

  • Investigational Site Number : 2500002

    RECRUITING

    Lille, 59037, France

  • Investigational Site Number : 2500003

    RECRUITING

    Paris, Washington, 75013, France

  • Investigational Site Number : 2500004

    RECRUITING

    Paris, 75015, France

  • Investigational Site Number : 2760006

    RECRUITING

    Frankfurt, 60590, Germany

  • Investigational Site Number : 2760008

    RECRUITING

    Lübeck, 23562, Germany

  • Investigational Site Number : 3000001

    RECRUITING

    Athens, 115 28, Greece

  • Investigational Site Number : 3000002

    RECRUITING

    Athens, 106 76, Greece

  • Investigational Site Number : 3760001

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Investigational Site Number : 3760002

    RECRUITING

    Jerusalem, 9112001, Israel

  • Investigational Site Number : 3760003

    RECRUITING

    Ramat Gan, 5262100, Israel

  • Investigational Site Number : 3800001

    RECRUITING

    Meldola, Reggio Emilia, 47014, Italy

  • Investigational Site Number : 4100001

    RECRUITING

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 4100002

    RECRUITING

    Seoul, Seoul-teukbyeolsi, 06351, South Korea

  • Investigational Site Number : 4100003

    RECRUITING

    Seoul, Seoul-teukbyeolsi, 06591, South Korea

  • Investigational Site Number : 4100004

    RECRUITING

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Investigational Site Number : 5780001

    RECRUITING

    Oslo, 0450, Norway

  • Puerto Rico Medical Research Center- Site Number : 8400005

    RECRUITING

    Hato Rey, Puerto Rico, 00917, Puerto Rico

  • Roswell Park Cancer Institute- Site Number : 8400008

    RECRUITING

    Buffalo, New York, 14263, United States

  • The Ohio State University- Site Number : 8400012

    RECRUITING

    Columbus, Ohio, 43210, United States

  • University of Illinois-Chicago - College of Medicine- Site Number : 8400007

    COMPLETED

    Chicago, Illinois, 60612, United States

  • University of Michigan Health System - Ann Arbor- Site Number : 8400004

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Winship Cancer Institute of Emory University- Site Number : 8400010

    RECRUITING

    Atlanta, Georgia, 30322, United States

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