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Promising combo aims to stop smoldering myeloma in its tracks

NCT ID NCT04270409

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether adding isatuximab (Sarclisa) to standard lenalidomide and dexamethasone can delay progression to active multiple myeloma in people with high-risk smoldering myeloma. About 337 participants will receive either the three-drug combo or the two-drug standard. The main goal is to see if the triple therapy extends the time before the disease becomes active.

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 lenalidomide and dexamethasone
What this could lead to
If successful, this combination could significantly delay or prevent the progression from smoldering to active multiple myeloma, potentially changing the standard of care for high-risk patients.
What could go wrong
This is an early-stage study in a specific high-risk population; results may not apply to all patients. Side effects from the drug combination could be significant, and the trial may not show a meaningful benefit over existing treatment.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

337 people

The number who actually took part.

Started

Jun 2020

Expected to finish

Oct 2033

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

Accepted

You do not need to have the condition being studied to take part.

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: * Participants who are diagnosed within 5 years with SMM (per International Myeloma Working Group \[IMWG\] criteria), defined as serum M-protein ≥30 g/L or urinary M-protein ≥500 mg per 24 hour or both, and/or clonal bone marrow plasma cells (BMPCs) 10% to \<60%, and absence of myeloma defining events or other related conditions and with high-risk SMM * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 or 2 * Capable of giving voluntary written informed consent * Absolute neutrophil count (ANC) ≥1000/µL (1 × 10\^9/L) * Platelets ≥50,000/µL (50 × 10\^9/L) * Total bilirubin ≤3 mg/dL (except Gilbert syndrome, in which direct bilirubin should be -≤5 mg/dL). * Alanine aminotransferase ≤3× upper limit of normal (ULN), aspartate aminotransferase ≤ 3 × ULN. Exclusion criteria: * Evidence of any of the following calcium, renal failure, anemia, bone lesions (CRAB) criteria or Myeloma Defining Events (SLiM CRAB) detailed below (attributable to the participants SMM involvement): * Increased calcium levels: Corrected serum calcium \>1 mg/dL above the ULN or \>11 mg/dL * Renal insufficiency: Determined by glomerular filtration rate (GFR) \<40 mL/min/1.73 m² (Modification of Diet in Renal Disease \[MDRD\] Formula) or serum creatinine \>2 mg/dL * Anemia (hemoglobin 2 g/dL below lower limit of normal or \<10 g/dL or both) transfusion support or concurrent treatment with erythropoietin stimulating agents is not permitted * ≥ 1 bone lytic lesion * BMPCs ≥60% * Serum involved/uninvolved FLC ratio ≥100 and an involved FLC ≥100mg/L * Whole body magnetic resonance imaging (WB-MRI) or positron emission tomography-computed tomography (PET-CT) with more than 1 bone focal lesion (≥5 mm in diameter by MRI) * Primary systemic amyloid light-chain (AL) amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), standard risk smoldering myeloma, soft tissue plasmacytoma, symptomatic myeloma * Uncontrolled infection within 28 days prior to randomization in Phase 3 or first study intervention administration in safety run-in * Clinically significant cardiac or vascular disease within 3 months prior to randomization, e.g. Myocardial Infarction; Unstable Angina; Coronary (e.g. Coronary Artery Bypass Graft, Percutaneous Coronary Intervention) or peripheral artery revascularization, Left Ventricular Ejection Fraction \<40%, Heart Failure NYHA III-IV, Stroke, Transient Ischemic Attack, Pulmonary Embolism, other thromboembolic event, cardiac arrhythmia (Grade 3 or higher by NCI-CTCAE Version 5.0) * Known acquired immunodeficiency syndrome (AIDS)-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 German participants and any other country where required as per local regulations and serology hepatitis B and C at screening will be tested for all participants * Uncontrolled or active hepatitis B virus (HBV) infection: Patients with positive Hepatitis B surface antigen (HBsAg) and/or HBV Deoxyribonucleic acid (DNA) Of note: * Patient can be eligible if anti-HBc Immunoglobulin G (IgG) positive (with or without positive anti-HBs) but HBsAg and HBV DNA are negative. If anti-HBV therapy in relation with prior infection was started before initiation of IMP, the anti-HBV therapy and monitoring should continue throughout the study treatment period. * Patients with negative HBsAg and positive HBV DNA observed during screening period will be evaluated by a specialist for start of anti-viral treatment: study treatment could be proposed if HBV DNA becomes negative and all the other study criteria are still met. * Active hepatitis C virus (HCV) infection: positive HCV ribonucleic acid (RNA) and negative anti-HCV Of note: * Patients with antiviral therapy for HCV started before initiation of IMP and positive HCV antibodies are eligible. The antiviral therapy for HCV should continue throughout the treatment period until seroconversion. * Patients with positive anti-HCV and undetectable HCV RNA without antiviral therapy for HCV are eligible * Malabsorption syndrome or any condition that can significantly impact the absorption of lenalidomide * Any of the following within 3 months prior to randomization (or first study intervention administration in safety run-in cohort): treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event * Received treatment (eg surgery, radiotherapy, medication) for a malignancy within 3 years of randomization (or first study intervention administration in safety run-in cohort) * Prior exposure to approved or investigational treatments for SMM or multiple myeloma (MM) (including but not limited to conventional chemotherapies, immunomodulatory imid drugs, or Proteasome inhibitors); concurrent use of bisphosphonates or receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor denosumab is not permitted; however, prior bisphosphonates or once-a-year intravenous bisphosphonate given for the treatment of osteoporosis is permitted * Ongoing treatment with corticosteroids with a dose \>10 mg prednisone or equivalent per day at the time of randomization (or first study intervention administration in safety run-in cohort) * Women of childbearing potential or male participant with women of childbearing potential who do not agree to use a highly effective method of birth control * Vaccination with a live vaccine 4 weeks before the start of the study drug. Seasonal flu vaccines that do not contain live virus are permitted The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma smoldering plasma cell myeloma

As listed by the trial registrant

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

Plasma cell myeloma

Contacts and locations

Locations

  • Cancer Specialist of North Florida Site Number : 8400011

    Jacksonville, Florida, 32256, United States

  • Colorado Blood Cancer Institute Site Number : 8400007

    Denver, Colorado, 80218, United States

  • Dana Farber Cancer Institute Site Number : 8400001

    Boston, Massachusetts, 02115, United States

  • Investigational Site Number : 2030001

    Prague, 12808, Czechia

  • Investigational Site Number : 2030002

    Olomouc, 77900, Czechia

  • Investigational Site Number : 2030003

    Ostrava - Poruba, 70852, Czechia

  • Investigational Site Number : 2030004

    Brno, 62500, Czechia

  • Investigational Site Number : 2030005

    Hradec Králové, 50005, Czechia

  • Investigational Site Number : 7920001

    Ankara, 06620, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    Istanbul, 34390, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Izmir, 35040, Turkey (Türkiye)

  • Investigational Site Number : 7920004

    Istanbul, 34214, Turkey (Türkiye)

  • Investigational Site Number : 7920005

    Ankara, 06010, Turkey (Türkiye)

  • Investigational Site Number :0360001

    Wollongong, New South Wales, 2500, Australia

  • Investigational Site Number :0360002

    Fitzroy, Victoria, 3065, Australia

  • Investigational Site Number :0360004

    Richmond, Victoria, 3121, Australia

  • Investigational Site Number :0360005

    Waratah, New South Wales, 2298, Australia

  • Investigational Site Number :0360006

    Nedlands, Western Australia, 6009, Australia

  • Investigational Site Number :0360007

    Heidelberg West, Victoria, 3081, Australia

  • Investigational Site Number :0360008

    Liverpool, New South Wales, 2170, Australia

  • Investigational Site Number :0760002

    São Paulo, São Paulo, 04537-081, Brazil

  • Investigational Site Number :1240001

    Montreal, Quebec, H1T 2M4, Canada

  • Investigational Site Number :1240004

    Edmonton, Alberta, T6G 1Z2, Canada

  • Investigational Site Number :1240005

    Moncton, New Brunswick, E1C 6Z8, Canada

  • Investigational Site Number :1560001

    Tianjin, 300020, China

  • Investigational Site Number :1560002

    Hangzhou, 310003, China

  • Investigational Site Number :1560003

    Hangzhou, 310003, China

  • Investigational Site Number :1560004

    Shanghai, 200032, China

  • Investigational Site Number :1560005

    Shenyang, 110022, China

  • Investigational Site Number :1560006

    Nanchang, 330006, China

  • Investigational Site Number :2080001

    Aalborg, 9000, Denmark

  • Investigational Site Number :2080002

    Roskilde, 4000, Denmark

  • Investigational Site Number :2080003

    Aarhus N, 8200, Denmark

  • Investigational Site Number :2080005

    Copenhagen, 2100, Denmark

  • Investigational Site Number :2500001

    Rennes, 35033, France

  • Investigational Site Number :2500002

    Poitiers, 86021, France

  • Investigational Site Number :2500003

    Lille, 59037, France

  • Investigational Site Number :2500005

    Paris, 75012, France

  • Investigational Site Number :2500006

    La Roche-sur-Yon, 85925, France

  • Investigational Site Number :2500007

    Grenoble, 38043, France

  • Investigational Site Number :2500009

    Ars-Laquenexy, 57085, France

  • Investigational Site Number :2500010

    Bayonne, 64109, France

  • Investigational Site Number :2500011

    Paris, 75013, France

  • Investigational Site Number :2760001

    Hamburg, 20246, Germany

  • Investigational Site Number :2760002

    Heidelberg, 69120, Germany

  • Investigational Site Number :3000001

    Athens, 11528, Greece

  • Investigational Site Number :3000002

    Athens, 10676, Greece

  • Investigational Site Number :3000003

    Thessaloniki, PC 54007, Greece

  • Investigational Site Number :3480001

    Budapest, 1097, Hungary

  • Investigational Site Number :3480002

    Debrecen, 4032, Hungary

  • Investigational Site Number :3480003

    Budapest, 1083, Hungary

  • Investigational Site Number :3480004

    Kaposvár, 7400, Hungary

  • Investigational Site Number :3720001

    Dublin, Dublin, Ireland

  • Investigational Site Number :3720002

    Dublin, Dublin, Ireland

  • Investigational Site Number :3720003

    Dublin, Dublin, Ireland

  • Investigational Site Number :3760001

    Jerusalem, 91031, Israel

  • Investigational Site Number :3760002

    Jerusalem, 91120, Israel

  • Investigational Site Number :3760003

    Tel Aviv, 64239, Israel

  • Investigational Site Number :3760004

    Ashdod, 7747629, Israel

  • Investigational Site Number :3760005

    Petah Tikva, 49100, Israel

  • Investigational Site Number :3760006

    Ramat Gan, 5265601, Israel

  • Investigational Site Number :3800001

    Rozzano, Milano, 20089, Italy

  • Investigational Site Number :3800002

    Terni, 05100, Italy

  • Investigational Site Number :3800003

    Bologna, 40138, Italy

  • Investigational Site Number :3800005

    Ancona, 60032, Italy

  • Investigational Site Number :3800006

    Meldola, Forlì-Cesena, 47014, Italy

  • Investigational Site Number :3920001

    Shibuya-ku, Tokyo, 150-8935, Japan

  • Investigational Site Number :3920002

    Nagoya, Aichi-ken, 467-8602, Japan

  • Investigational Site Number :3920003

    Okayama, Okayama-ken, 701-1192, Japan

  • Investigational Site Number :3920005

    Higashiibaraki-gun, Ibaraki, 311-3193, Japan

  • Investigational Site Number :3920006

    Kamogawa-shi, Chiba, 296-8602, Japan

  • Investigational Site Number :3920008

    Maebashi, Gunma, 371-8511, Japan

  • Investigational Site Number :3920009

    Sunto-gun, Shizuoka, 411-8777, Japan

  • Investigational Site Number :4100001

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Investigational Site Number :4100002

    Seoul, 06591, South Korea

  • Investigational Site Number :4100003

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number :4100004

    Gangnam-gu, Seoul-teukbyeolsi, 06351, South Korea

  • Investigational Site Number :4400001

    Vilnius, 08661, Lithuania

  • Investigational Site Number :5540001

    Hamilton, Waikato Region, 3204, New Zealand

  • Investigational Site Number :5540004

    Christchurch, Canterbury, New Zealand

  • Investigational Site Number :5780001

    Oslo, 0450, Norway

  • Investigational Site Number :5780002

    Bergen, 5021, Norway

  • Investigational Site Number :6160002

    Lodz, Lódzkie, 93-510, Poland

  • Investigational Site Number :6160005

    Chorzów, Silesian Voivodeship, 41-500, Poland

  • Investigational Site Number :6160006

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

  • Investigational Site Number :6160008

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Investigational Site Number :7240001

    Barcelona, Barcelona [Barcelona], 08041, Spain

  • Investigational Site Number :7240002

    Valencia, Valenciana, Comunidad, 46017, Spain

  • Investigational Site Number :7240003

    Zaragoza, 50009, Spain

  • Investigational Site Number :7240004

    Barcelona, Barcelona [Barcelona], 08036, Spain

  • Investigational Site Number :7240005

    Madrid, 28041, Spain

  • Investigational Site Number :7240006

    Pamplona, Navarre, 31008, Spain

  • Investigational Site Number :7240007

    Salamanca, 37007, Spain

  • Investigational Site Number :7520001

    Gothenburg, 413 45, Sweden

  • Investigational Site Number :7520003

    Helsingborg, 251 87, Sweden

  • Investigational Site Number :8260001

    Leicester, LE15WW, United Kingdom

  • Investigational Site Number :8260002

    Bournemouth, Hampshire, BH7 7DW, United Kingdom

  • Investigational Site Number :8260003

    London, London, City of, SE1 7EH, United Kingdom

  • Investigational Site Number :8260004

    Southampton, SO16 6YD, United Kingdom

  • Novant Health Forsyth Medical Center Site Number : 8401015

    Winston-Salem, North Carolina, 27103, United States

  • Presbyterian Hospital Site Number : 8400015

    Charlotte, North Carolina, 28204, United States

  • Tennessee Oncology Site Number : 8400006

    Nashville, Tennessee, 37203, United States

  • UCLA Site Number : 8400010

    Los Angeles, California, 90024, United States

  • University of Miami Site Number : 8400012

    Miami, Florida, 33136, United States

  • ~University of Texas - MD Anderson Cancer Center Site Number : 8400002

    Houston, Texas, 77030, United States

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