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Could a drug combo replace chemo and transplant for multiple myeloma?

NCT ID NCT06918002

Disease control Sponsor: Intergroupe Francophone du Myelome 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Updated 2 times

Summary

This study tests whether a combination of two drugs (elranatamab and lenalidomide) can replace high-dose chemotherapy and stem cell transplant for people newly diagnosed with multiple myeloma. About 824 adults under 70 will be randomly assigned to either standard treatment or the experimental drug combo. After initial therapy, participants will be re-randomized to receive either standard maintenance or elranatamab alone to see which better prevents the cancer from returning.

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

About 824 people

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

Started

Jul 2025

Expected to finish

May 2036

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

18 to 69 years

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: 1. Male or female subjects, aged over 18 but \< 70 years old 2. Patients have provided voluntary written informed consent before performing any study-related procedure. 3. Patients with newly diagnosed multiple myeloma (NDMM) eligible for high-dose chemotherapy (melphalan) and autologous stem cell transplantation (ASCT). 4. Patients with documented symptomatic NDMM according to CRAB and/or SLIM criteria, with measurable disease as defined by: * Presence of ≥10% monoclonal plasma cells in the bone marrow OR presence of a biopsy-proven plasmacytoma. In addition, the patient must have ≥1 of the following myeloma defining events: \- Hypercalcemia: serum calcium \>0.25 mmol/L (\>1 mg/dL) higher than upper limits of normal (ULN) or \>2.75 mmol/L (\>11 mg/dL). \- Renal insufficiency: creatinine clearance \< 40mL/min/1.73 m2 using CKD-EPI or serum creatinine \>177 μmol/L (\>2 mg/dL). \- Anemia: hemoglobin \>2 g/dL below the lower limit of normal (LLN) or hemoglobin \<10 g/dL. \- Bone lesions: ≥1 osteolytic lesion on skeletal radiography, CT or PET-CT. \- Clonal bone marrow plasma cell percentage ≥60%. \- Serum involved/uninvolved free light chain ratio ≥100. * More than 1 focal lesion (≥5 mm diameter) on MRI. * Measurable disease as defined by serum M-component ≥5 g/L, and/or urine M-component ≥200 mg/24 h and/or serum FLC ≥100 mg/L. 5. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2. 6. Patients must have clinical laboratory values (within 15 days of initiating induction therapy) as follows: • Hemoglobin ≥7.5 g/dL (≥5 mmol/L). Prior red blood cell (RBC) transfusion or the use of recombinant human erythropoietin is permitted. • Absolute neutrophil count (ANC) ≥1.0 G/L (granulocyte colony stimulating factor \[G-CSF\] use is permitted). • Aspartate aminotransferase (AST) ≤3 x ULN. • Alanine aminotransferase (ALT) ≤ 3 x ULN. • Total bilirubin ≤3 x ULN (except in subjects with congenital bilirubinemia, such as Gilbert syndrome, that require a direct bilirubin ≤3 x ULN). • Calculated creatinine clearance ≥40 mL/min/1.73 m². * Albumin corrected serum calcium ≤14 mg/dL (\<3.5 mmol/L); or free-ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L). * Platelet count ≥50 Giga/L for subjects who have \<50% of bone marrow nucleated cells as plasma cells. If not, platelet count \>30 G/L (platelets transfusions done during the 15 days before initiating induction therapy are not permitted). 7. Women of childbearing potential must have a negative serum or urine pregnancy test during the screening period before randomization AND within 3 days before of initiating induction therapy. 8. Patients must be willing and able to comply with scheduled appointments, treatment plan, laboratory tests, and other study procedures (such as blood transfusion if required, ASCT, IVIG prophylaxis, etc.). Exclusion Criteria: 1. Subjects previously treated with any systemic therapy for multiple myeloma. Patients are allowed corticosteroids before or during screening, as far as the total dose received is not \>160 mg of dexamethasone (or equivalent) within 14 days before initiating induction therapy. Patients with concurrent radiotherapy within the 14 days before initiating induction therapy are not eligible (If possible, in these cases, enrolment should be deferred). 2. Subject with ongoing Grade ≥ 3 peripheral sensory or motor neuropathy. 3. Subject with history of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy. 4. Subject with a current diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or solitary plasmacytoma. 5. Subject has a diagnosis of Waldenström's macroglobulinemia, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions. 6. The subject has had plasmapheresis within 14 days of initiating induction therapy. 7. Subject with clinical signs of meningeal involvement of multiple myeloma. 8. The subject has plasma cell leukemia (by WHO criterion: ≥5% of plasma cells in the peripheral blood) or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes). 9. Subject has any concurrent medical or psychiatric condition or disease (e.g., active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study. 10. Subject has clinically significant cardiac disease, including: • Subject has had myocardial infarction within 1 year before initiating induction therapy, or currently has an unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association \[NYHA\] class III IV). * Subject has uncontrolled cardiac arrhythmia (common terminology criteria for adverse events \[CTCAE\] version 4 grade ≥2) or clinically significant electrocardiography (ECG) abnormalities. * Subject with a baseline QT interval as corrected by Fridericia's formula (QTcF) \>470 msec (12-lead ECG). 11. Subjects taking systemic treatment with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort (millepertuis) within the 14 days before initiating induction therapy. 12. Known intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents. 13. Known allergies to any of the study medications, their analogues, or excipients in the various formulations. 14. Subjects who have had major surgery within 2 weeks before study inclusion (signing of the informed consent) OR will not have fully recovered from surgery before initiating induction therapy OR have surgery planned during their study participation. Kyphoplasty and vertebroplasty are not considered as major surgery. 15. Subjects with any prior or concurrent malignancy (other than multiple myeloma) within 5 years of study inclusion study, except for adequately treated basal cell or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or localized prostate adenocarcinoma diagnosed ≥3 years ago and without evidence of biological failure, or other cancers for which the subject has undergone potentially curative therapy and has without evidence of relapse/recurrence for ≥5 years. 16. Pregnant or breast-feeding women. Women that refuse to abstain from heterosexual intercourse or refuse to use adequate contraceptives during heterosexual intercourse starting at least 4 weeks before initiating induction therapy and continually until at least 4 weeks after discontinuing lenalidomide,90 days after discontinuing daratumumab and 6 months after discontinuing elranatamab. 18\. Men with partners of childbearing potential, even men with a successful vasectomy, that refuse to use a condom during intercourse, from initiating induction therapy to ≥4 weeks ys after discontinuing lenalidomide,. Furthermore, men must agree to not donate sperm during this period. 19\. Known positive for HIV or active hepatitis A, B or C: Uncontrolled or active HBV infection: Patients with positive HBsAg and/or HBV DNA Of note: Patients can be eligible if anti-HBc IgG positive (with or without positive anti-HBs) but HBsAg and HBV DNA are negative. o If anti-HBV therapy in relation to 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 HCV infection: positive HCV 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. 20\. Patient with an active systemic infection or severe infections requiring parenteral administration of antibiotics. 21\. Patients with a gastrointestinal disease/disorder that may significantly impact the absorption of oral treatments. 22\. Patients unable or unwilling to undergo antithrombic prophylaxis. 23\. A person under guardianship, trusteeship, or deprived of freedom by a judicial or administrative decision.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Multiple myeloma, newly diagnosed

How to take part

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

  1. The places running it

    64 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • CH Bretagne Atlantique Vannes et Auray - P. Chubert

    RECRUITING

    Vannes, France

  • CH Fleyriat

    RECRUITING

    Bourg-en-Bresse, France

  • CH Le mans

    RECRUITING

    Le Mans, France

  • CH Saint Jean

    RECRUITING

    Perpignan, France

  • CHD Vendée

    RECRUITING

    La Roche-sur-Yon, France

  • CHMS Centre Hospitalier Métropole Savoie

    RECRUITING

    Chambéry, France

  • CHR Orléans

    RECRUITING

    Orléans, France

  • CHRU Brest - Hôpital A. Morvan

    RECRUITING

    Brest, France

  • CHRU Hôpital Bretonneau - Centre Henry Kaplan

    RECRUITING

    Tours, France

  • CHRU Hôpital Claude Huriez

    RECRUITING

    Lille, France

  • CHRU Hôpital de Pontchaillou

    RECRUITING

    Rennes, France

  • CHRU Hôpitaux de Brabois

    RECRUITING

    Nancy, France

  • CHRU Hôtel Dieu

    RECRUITING

    Nantes, France

  • CHU Amiens

    RECRUITING

    Amiens, France

  • CHU Angers

    RECRUITING

    Angers, France

  • CHU Besançon

    RECRUITING

    Besançon, France

  • CHU Bordeaux - Hopital Haut Lévêque - Centre F. Magendi

    RECRUITING

    Bordeaux, France

  • CHU Caen - Côte de Nacre

    RECRUITING

    Caen, France

  • CHU Carémeau, Institut de Cancérologie du Guard

    NOT_YET_RECRUITING

    Nîmes, France

  • CHU Dijon

    RECRUITING

    Dijon, France

  • CHU Henri Mondor

    RECRUITING

    Créteil, France

  • CHU Hôpital Saint Antoine

    RECRUITING

    Paris, France

  • CHU Poitiers - Pôle régional de Cancérologie

    RECRUITING

    Poitiers, France

  • CHU Strasbourg

    NOT_YET_RECRUITING

    Strasbourg, France

  • CHU de Grenoble

    RECRUITING

    Grenoble, France

  • CHU de la Réunion Site SUD (Terre Sainte)

    RECRUITING

    La Réunion, France

  • CHV André Mignot - Université de Versailles

    RECRUITING

    Versailles, France

  • Centre Henri Becquerel

    RECRUITING

    Rouen, France

  • Centre Hospitalier H. Duffaut

    RECRUITING

    Avignon, France

  • Centre Hospitalier Lyon Sud

    RECRUITING

    Lyon, France

  • Centre Hospitalier Saint Brieuc

    RECRUITING

    Saint-Brieuc, France

  • Centre Hospitalier Simone Veil

    RECRUITING

    Blois, France

  • Centre Hospitalier Sud Francilien

    RECRUITING

    Corbeil-Essonnes, France

  • Centre Hospitalier Universitaire (CHU) de Limoges

    RECRUITING

    Limoges, France

  • Centre Hospitalier William Morey

    RECRUITING

    Chalon-sur-Saône, France

  • Centre Hospitalier d'Argenteuil Victor Dupouy

    RECRUITING

    Argenteuil, France

  • Centre Hospitalier de Dunkerque

    RECRUITING

    Dunkirk, France

  • Centre Hospitalier de Perigueux

    RECRUITING

    Périgueux, France

  • Centre Hospitalier de Quimper Cornouaille

    RECRUITING

    Quimper, France

  • Centre Hospitalier de Saint-Quentin

    RECRUITING

    Saint-Quentin, France

  • Centre Léon Bérard

    NOT_YET_RECRUITING

    Lyon, 69373, France

  • Centre de Recherche Clinique / GHT des Landes

    RECRUITING

    Mont-de-Marsan, France

  • Centre hospitalier

    RECRUITING

    Tarbes, France

  • Centre hospitalier René Dubost

    RECRUITING

    Pontoise, France

  • Centre hospitalier de la Côte Basque

    RECRUITING

    Bayonne, France

  • Ch Annecy Genevois

    RECRUITING

    Annecy, France

  • Chu Estaing

    RECRUITING

    Clermont-Ferrand, France

  • Grand Hopital Est Francilien (GHEF) Site de Meaux

    RECRUITING

    Meaux, France

  • Gustave Roussy

    RECRUITING

    Villejuif, France

  • Hopital Louis Pasteur

    RECRUITING

    Chartres, France

  • Hopital Monod

    RECRUITING

    Le Havre, France

  • Hopital Saint Eloi - CHU Montpellier

    RECRUITING

    Montpellier, France

  • Hôpital Archet 1

    RECRUITING

    Nice, France

  • Hôpital Avicenne

    RECRUITING

    Bobigny, France

  • Hôpital Cochin

    RECRUITING

    Paris, France

  • Hôpital E. Muller

    RECRUITING

    Mulhouse, France

  • Hôpital Necker

    RECRUITING

    Paris, France

  • Hôpital Saint Louis

    RECRUITING

    Paris, France

  • Hôpital d'Instruction des Armées Percy

    RECRUITING

    Clamart, France

  • Hôpital de Mercy (CHR Metz-Thionville)

    RECRUITING

    Metz, France

  • Institut de Cancérologie Lucien Neuwirth

    RECRUITING

    Saint-Priest, France

  • Institut de cancérologie de Bourgogne

    RECRUITING

    Dijon, France

  • La Pitié Salpêtrière

    RECRUITING

    Paris, France

  • Pôle IUCT Oncopole CHU

    RECRUITING

    Toulouse, France

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Other studies related to the condition(s) this trial covers.