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Multiple MyelomaPhase 2IFM 2024_06NCT06931704

Comparison of Elranatamab and Lenalidomide Versus Daratumumab and Lenalidomide as Post-transplant Maintenance Therapy in Patients With Newly Diagnosed Myeloma (ElMMA)

A Phase 2 study testing Elranatamab, Daratumumab and Lenalidomide in people with Multiple Myeloma, run by Nantes University Hospital at 36 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Lenalidomide is a standard of care for maintenance therapy after autologous stem cell transplantation in newly diagnosed myeloma patients. Recently, two large phase 3 randomized trials demonstrated a progression free survival benefit with daratumumab maintenance post autologous stem cell transplantation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Elranatamab, Daratumumab and Lenalidomide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
36 sitesFrance
Study dates
1 May 2025to 30 Nov 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • - Male or female subjects, 18 years of age or older
  • - Voluntary written informed consent must be given before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.
  • - Subject must have documented multiple myeloma according to International Myeloma Working Group (IMWG) criteria and have received 4 to 6 cycles of quadruplet-based therapy including proteasome inhibitor, IMID and anti CD38 monoclonal antibody.
  • - Subject must have received only one line of therapy and achieved at least a partial response as per IMWG 2016 criteria.
  • - Subject must have received high-dose melphalan and ASCT within 12 months of the start of induction therapy and be within 6 months of the last ASCT at the time of first treatment dose.
  • - Subject must have NGS analysis performed at time of MM diagnosis and/or adequate stored bone marrow material allowing NGS analysis (IUCT-Oncopole, Toulouse, France) in order to calibrate MRD analysis.
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  • - Karnofsky performance status score ≥ 50% (eastern cooperative oncology group performance status ECOG score ≤ 2).
  • - Subject must have clinical laboratory values meeting the following criteria during the Screening Phase:
  • Hematology : Hemoglobin >8.0 g/dL without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted) + Platelets ≥75×109/L (without transfusion support or thrombopoietin receptor agonist within 7 days before the laboratory test) + Absolute neutrophil count ≥1.0×109/L (prior growth factor support is permitted but must be without support for 7 days for G-CSF or 14 days for pegylated-G-CSF)
  • Chemistry : AST and ALT ≤2.5× upper limit of normal (ULN) + CrCl ≥30 mL/min based on Cockroft-Gault formula calculation or a 24-hour urine collection + Total bilirubin ≤1.5×ULN; except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤1.5×ULN is required) + Serum calcium corrected for albumin ≤14 mg/dL (≤3.5 mmol/L)
  • - Women of childbearing potential must have a negative serum or urine pregnancy test within 10 to 14 days prior to therapy and repeated within 24 hours before starting study drug. They must commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control (One highly effective method and one additional effective method) used at the same time, beginning at least 4 weeks before initiation of lenalidomide treatment and continuing for at least 6 months after the last dose of Lenalidomide or Elranatamab depending on the last treatment taken. Highly effective contraceptive methods are defined as any of the following methods: combined hormonal contraception (containing estrogen and progestin) combined with ovulation inhibition (oral, intravaginal, transdermal), progestin-only hormonal contraception combined with ovulation inhibition (oral, injectable, implantable), intrauterine device (IUD), hormone-releasing intrauterine system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence.Women must also agree to notify pregnancy during the study.
  • - Men must agree to not father a child and agree to use a latex condom during therapy and for 6 months after the last dose of study drug, even if they have had a successful vasectomy, if their partner is of childbearing potential.

Who cannot join

  • - Subjects have received any prior anti BCMA therapy.
  • - Subject have received post transplantation maintenance therapy.
  • - Subject intolerant to lenalidomide or have discontinued treatment due to any AE related to lenalidomide.
  • - Subject is exhibiting clinical signs of meningeal involvement of multiple myeloma.
  • - Myocardial infarction within 6 months prior to enrollment according to NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
  • - Uncontrolled hypertension.
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  • - Subjects with known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) < 50% of predicted normal. Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 < 50% of predicted normal.
  • - Subjects with a history of moderate or severe persistent asthma within the past 2 years, or with uncontrolled asthma of any classification at the time of screening (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study).
  • - Subject has plasma cell leukemia (according to WHO criterion: ≥ 20% of cells in the peripheral blood with an absolute plasma cell count of more than 2 × 109/L) or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
  • - 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 within 14 days before the first dose of study treatment.
  • - Known intolerance to steroid therapy.
  • - History of allergy to any of the study medications, their analogues, or excipients in the various formulations.
  • - Subject has had major surgery within 2 weeks before randomization or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study. Kyphoplasty or Vertebroplasty are not considered major surgery.
  • - Clinically relevant active infection or serious co-morbid medical conditions.
  • - Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer free of disease since 5 years.
  • - Female subject who is pregnant or breast-feeding.
  • - Serious medical or psychiatric illness likely to interfere with participation in study.
  • - Uncontrolled diabetes mellitus.
  • - Active HBV, HCV, SARS-CoV-2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection. Active infections must be resolved at least 21 days prior to enrollment. Treatment with systemic anti-infective agents must have completed at least 28 days prior to enrollment. Prophylactic use of systemic agents is permitted.
  • COVID-19/SARS-CoV-2: SARS-CoV-2 PCR testing is mandated within 5 days prior to enrollment. Participants with positive PCR test result for SARS-CoV-2 within 5 days prior to enrollment, or suspected of having SARS-CoV-2, are excluded.
  • HIV: In equivocal cases, participants whose viral load is negative may be eligible. HIV seropositive participants who are otherwise healthy and at low risk for AIDS-related outcomes could be considered eligible. Potential eligibility for a specific HIV positive protocol candidate should be evaluated and discussed with the sponsor prior to screening, considering current and past CD4+ and T-cell counts, history (if any) of AIDS defining conditions (eg, opportunistic infections), status of HIV treatment and the potential for drug-drug interactions.
  • HBV:
  • Participants with a positive HBsAg test (ie, either acute or chronic active hepatitis) are excluded.
  • Participants with HBV antibody positivity indicating immunity, either due to vaccination or prior natural infection, are eligible.
  • Participants with positive anti-HBcAb but negative HBsAg and negative anti-HBsAb profile are eligible if HBV DNA is not detected.
  • For additional details, refer to CDC website (https://www.cdc.gov/hepatitis/HBV/PDFs/SerologicChartv8.pdf).
  • HCV: Positive HCV antibody is indicative of infection but may not necessarily render a potential candidate ineligible, depending on clinical circumstances. If exposure to HCV is recent, HCV antibody may not have yet turned positive. In these circumstances it is recommended to test for HCV RNA. If HCV RNA is detected, the patient is not eligible. Refer to CDC website for further details(https://www.cdc.gov/hepatitis/hcv/pdfs/hcv_graph.pdf).
  • - Incidence of gastrointestinal disease that may significantly alter the absorption of oral drugs.
  • - Subjects unable or unwilling to undergo antithrombotic prophylactic treatment.
  • - Person under guardianship, trusteeship or deprived of freedom by a judicial or administrative decision.

Trial locations and contacts

36 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Cyrille TOUZEAU contact

02 40 08 32 71

cyrille.touzeau@chu-nantes.fr

36 sites in 1 country

France36 sites

  • CHU Angers

    Angers

    Mammoun DIB, 02 41 35 47 05 ext. +33, MaDib@chu-angers.fr

  • CH Côte Basque

    Bayonne

    Julie GAY, 05 59 44 38 32 ext. +33, jgay@ch-cotebasque.fr

  • CHU Besançon

    Besançon

    Jean FONTAN, 03 81 66 82 32 ext. +33, jfontan@chu-besancon.fr

  • CHU Caen

    Caen

    Margaret MACRO, 02 31 27 21 22 ext. +33, macro-m@chu-caen.fr

  • Hôpital d'Instruction des Armées Percy

    Clamart

    Jean MAILLOT, 01 41 46 63 01 ext. +33, jean.maillot@intradef.gouv.fr

  • CHU Clermont- Ferrand - Hôpital ESTAING

    Clermont-Ferrand

    Carine CHALETEIX, 04 73 75 00 65 ext. +33, cchaleteix@chu-clermontferrand.fr

  • Hôpital Henri Mondor

    Créteil

    Romain GOUNOT, 01 49 81 43 20 ext. +33, romain.gounot@aphp.fr

  • CHRU Dijon

    Dijon

    Andrea PIERAGOSTINI, 03 80 29 50 41 ext. +33, andrea.pieragostini@chu-dijon.fr

  • Institut de cancérologie de Bourgogne

    Dijon

    Marie-Lorraine CHRETIEN-MEURIOT, 03 80 29 45 06 ext. +33, mlchretien@icb-cancer.fr

  • Hôpital Annecy Genevois

    Épagny

    Frédérique ORSINI-PIOCELLE, 04 50 63 66 08 ext. +33, forsinipiocelle@ch-annecygenevois.fr

  • CHD Vendée

    La Roche-sur-Yon

    Komivi AGBETSIVI, 02 51 44 61 73 ext. +33, komivi.agbetsivi@chd-vendee.fr

  • CH Le Mans - Centre de cancérologie de la Sarthe

    Le Mans

    Kamel LARIBI, 02 55 46 34 67 ext. +33, klaribi@ch-lemans.fr

  • CH de Libourne

    Libourne

    Elodie SCHERMAN, 05 57 55 26 17 ext. +33, elodie.scherman@ch-libourne.fr

  • CHU Limoges

    Limoges

    Murielle ROUSSEL, 05 55 05 66 51 ext. +33, murielle.roussel@chu-limoges.fr

  • Groupement Hospitalier Bretagne Sud

    Lorient

    Adrien TREBOUET, 02 97 06 91 85 ext. +33, a.trebouet@ghbs.bzh

  • Centre Léon BERARD

    Lyon

    Philippe REY, 04 26 55 67 95 ext. +33, philippe.rey@lyon.unicancer.fr

  • IPC Marseille

    Marseille

    Jean-Marc SCHIANO DE COLELLA, 04 91 22 38 66 ext. +33, schianodecolella@ipc.unicancer.fr

  • CHRU Nancy

    Nancy

    Caroline JACQUET, 03 83 15 52 49 ext. +33, c.jacquet@chru-nancy.fr

  • CHU Nantes

    Nantes

    Cyrille TOUZEAU, 02 40 08 32 71 ext. +33, cyrille.touzeau@chu-nantes.fr

  • CHU de Nice - Hôpital l'Archet 1

    Nice

    Valentine RICHEZ-OLIVIER, 04 92 03 58 41 ext. +33, richez-olivier.v@chu-nice.fr

  • CHU de Nîmes - Institut de Cancérologie du Gard

    Nîmes

    Nicolas BRANCHE, 04 66 68 40 33 ext. +33, nicolas.branche@chu-nimes.fr

  • Hopital St Louis

    Paris

    Bertrand ARNULF, 01 42 49 94 72 ext. +33, bertrand.arnulf@sls.aphp.fr

  • Hôpital Cochin

    Paris

    Marguerite VIGNON, 01 58 41 21 10 ext. +33, marguerite.vignon@aphp.fr

  • Hôpital Necker

    Paris

    Laurent FRENKEL, 01 44 49 52 92 ext. +33, laurent.frenzel@aphp.fr

  • Hôpital St Antoine

    Paris

    Mohamad MOHTY, 01 49 28 26 24 ext. +33, mohamad.mohty@inserm.fr

  • CH Périgueux

    Périgueux

    Claire CALMETTES, 05 53 45 25 85 ext. +33, claire.calmettes@ch-perigueux.fr

  • CH Saint-Jean

    Perpignan

    Virginie ROLAND, 04 68 61 89 07 ext. +33, virginie.roland@ch-perpignan.fr

  • CHRU - Hôpital du Haut Lévêque

    Pessac

    Cyrille HULIN, 05 57 65 65 11 ext. +33, cyrille.hulin@chu-bordeaux.fr

  • CHU de Poitiers

    Poitiers

    Xavier LELEU, 05 49 44 37 17 ext. +33, xavier.leleu@chu-poitiers.fr

  • CH Cornouaille Quimper

    Quimper

    Ronan LE CALLOCH, 02 98 52 67 16 ext. +33, r.lecalloch@ch-cornouaille.fr

  • CH de Saint Nazaire

    Saint-Nazaire

    Marion LOIRAT, 02 72 27 83 22 ext. +33, m.loirat@ch-saintnazaire.fr

  • ICANS

    Strasbourg

    Cécile SONNTAG, 03 68 76 73 01 ext. +33, c.sonntag@icans.eu

  • CH Tarbes-Lourdes

    Tarbes

    Noémie GADAUD, 05 62 54 61 10 ext. +33, ngadaud@ch-tarbes-vic.fr

  • CHU Toulouse

    Toulouse

    Aurore PERROT, 05 31 15 64 90 ext. +33, perrot.aurore@iuct-oncopole.fr

  • CHRU Bretonneau

    Tours

    Thomas CHALOPIN, 02 47 47 37 12 ext. +33, t.chalopin@chu-tours.fr

  • CH Bretagne Atlantique

    Vannes

    Pascal GODMER, 02 97 01 41 45 ext. +33, pascal.godmer@ch-bretagne-atlantique.fr

Other trials in France

About this study

Official title: A Multi-center, Open-label, Phase 2 Randomized Study of Elranatamab Plus Lenalidomide Versus Daratumumab Plus Lenalidomide as Post Transplantation Maintenance Therapy in Patients With Newly-diagnosed Myeloma. IFM 2024-06

Lenalidomide is a standard of care for maintenance therapy after autologous stem cell transplantation in newly diagnosed myeloma patients. Recently, two large phase 3 randomized trials demonstrated a progression free survival benefit with daratumumab maintenance post autologous stem cell transplantation. Bispecific antibodies targeting B-Cell Maturation Antigen are approved for the treatment of relapsed refractory myeloma patients after 3 prior lines of therapy including proteasome inhibitor, immunomodulator IMiD and anti CD38 monoclonal antibody. In the cohort A of the MAGNETISMM-3 phase 2 study (n=123), elranatamab single-agent demonstrated strong efficacy with favorable safety profile in patients with advanced multiple myeloma (median of 5 prior lines, 96% of patients with triple class refractory disease). Lenalidomide has been shown to promote cytotoxic activity of CD3 bispecific antibodies. 7We propose a phase 2 randomized study comparing elranatamab plus lenalidomide versus daratumumab plus lenalidomide for 2 years as post-transplant maintenance in patients with newly diagnosed multiple myeloma. The primary objective is minimal residual disease rate after one year of maintenance. Secondary objectives include Progression-Free Survival, safety, quality of life, return to work and overall survival.

Read the detailed description

Post transplant maintenance with daratumumab and lenalidomide is now considered a standard of care in transplant eligible newly diagnosed myeloma patients. The T-cell engager elranatamab is approved for relapsed myeloma patients, and is currently evaluated in frontline therapy. The combination of bispecific antibody with lenalidomide demosntrated promising response rates with favorable safety profile.

The phase 2 randomized study ELMMA aims to compare the efficacy and safety of elranatamab plus lenalidomide verus daratumumab plus lenalidomide for 2 years as post-transplant maintenance in newly diagnosed myeloma patients.

Target population: n=176, newly diagnosed myeloma transplant eligible following 4-6 cycles of quadruplet induction and autologous stem cell transplantation.

Being tested
Elranatamab, Daratumumab, Lenalidomide
Keywords
Multiple Myeloma, maintenance, elranatamab, lenalidomide, daratumumab
Medical subject headings
Multiple Myeloma

What participants receive

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

  • ElranatamabDrug

    Each injection may be up to 2 mL in volume; however, if the maximum volume allowed per institution's policy is lower than 2 mL, the number of injections may be increased to accommodate this difference in volume and ensure the correct dose is delivered. Elranatamab should be administered to the abdomen, with preference given to the lower quadrants when possible.

    Each participant may receive study intervention for a maximum of 24 cycles.

  • DaratumumabDrug

    1800 mg will be administrated every cycles

  • LenalidomideDrug

    Daily administarted during 21 days, at each cycle

Study groups in NCT06931704
Study groupRoleWhat they receive
Usual care : Daratumumab + LenalidomideActive comparatorNot described
Receives: Drug: Daratumumab; Drug: Lenalidomide
Comparative treatment : Elranatamab + LenalidomideExperimentalNot described
Receives: Drug: Elranatamab; Drug: Lenalidomide

What is being measured

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

  1. Minimal Residual Disease negativity rate

    Minimal Residual Disease negativity rate (10-6, NGS) status after 12 cycles of maintenance

    Measured: At the beginning of cycle 13 (each cycle is 28 days)

Secondary outcomes (9)

  1. Safety and tolerability of Dara-Len and Elra-Len

    Presence and severity of Treatment-Emergent Adverse Events defined by National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (Number of Treatment-Emergent Adverse Events), except for Cytokine Release Syndrome and Immune effector Cell-Associated Neurotoxicity syndrome, which will be assessed based on American Society for Transplantation and Cellular Therapy guidelines.

    Measured: 4 years

  2. Progression-free survival

    Progression-free survival, defined as the time from randomization to the first occurrence of Progressive Disease, or death from any cause, whichever occurs first. Subjects alive and for whom disease progression has not been observed will be censored at the last date of follow-up.

    Measured: 4 years

  3. Minimal Residual Disease negativity with the threshold evaluated at one year after randomisation

    Rate of Minimal Residual Disease status at one year after randomisation

    Measured: At the beginning of cycle 13 (each cycle is 28 days)

  4. Minimal Residual Disease negativity with the threshold evaluated at one two years

    Rate of Minimal Residual Disease status at two years after randomization

    Measured: At the beginning of cycle 25 (each cycle is 28 days)

  5. Sustained Minimal Residual Disease negativity

    Rate of patients with Minimal Residual Disease negative status during at least 12 months (at least two consecutive times)

    Measured: At the beginning of cycle 13 and 25 (each cycle is 28 days)

  6. Complete Response or better

    The rate of complete response or better as defined by International Myeloma Working Group 2016

    Measured: 4 years

  7. Overall survival

    Time from randomisation to the date of death due to any cause. Subjects alive will be censored at the last date of follow-up.

    Measured: 4 years

  8. Progression-free survival 2

    Time from randomization to either second line Progressive Disease (assessed by investigator on the first subsequent line of antimyeloma therapy) or death, whichever occurs first. Subjects alive and for whom a second disease progression has not been observed will be censored at the last date of follow-up.

    Measured: 4 years

  9. Ability of return to work

    Ability of return to work assessed by a specific questionnaire

    Measured: At the beginning of cycle 1 (each cycle is 28 days), at 3 months, 6 months, 12 months, 24 months, 36 months and 48 months

Timeline

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

  1. First posted17 Apr 2025
  2. Study start1 May 2025 (estimated)
  3. Primary completion30 Nov 2030 (estimated)
  4. Study completion30 Nov 2031 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06931704
Sponsor's protocol ID
RC23_0603
Acronym
IFM 2024_06
Status last verified
Apr 2025
First submitted
1 Apr 2025
Last updated
23 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elranatamab, Daratumumab and Lenalidomide in people with Multiple Myeloma, run by Nantes University Hospital at 36 sites in France.

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 12 inclusion and 30 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: opening soon, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Cyrille TOUZEAU (02 40 08 32 71, cyrille.touzeau@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minimal Residual Disease negativity rate (time frame: At the beginning of cycle 13 (each cycle is 28 days)). 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 NCT06931704.

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 23 Apr 2025.

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