Multiple Myeloma, Newly DiagnosedPhase 3ElLenNCT06918002
Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM Patients
A Phase 3 study testing Elranatamab, Lenalidomide (Revlimid®) and Daratumumab SC (Darzalex) in people with Multiple Myeloma, Newly Diagnosed, run by Intergroupe Francophone du Myelome at 69 sites in 2 countries.
Trial summary
This study is designed as a multicenter, randomized, parallel groups, open-label, phase 3 study in subjects with untreated newly diagnoses Multiple Myeloma eligible for ASCT. 824 patients will be enrolled in this study from approximately 70 study sites. The 2 parts in the Treatment Phase are described below. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Multiple Myeloma, Newly Diagnosed
- What is being tested?
- Elranatamab, Lenalidomide (Revlimid®) and Daratumumab SC (Darzalex)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 824 participants
- Where
- 69 sitesin 2 countries
- Study dates
- 9 Jul 2025to May 2036
- Phase
- Phase 3
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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, aged over 18 but < 70 years old
- Patients have provided voluntary written informed consent before performing any study-related procedure.
- Patients with newly diagnosed multiple myeloma (NDMM) eligible for high-dose chemotherapy (melphalan) and autologous stem cell transplantation (ASCT).
- 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).
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- 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.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.
- 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).
- 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.
- 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.).
Who cannot join
- 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).
- Subject with ongoing Grade ≥ 3 peripheral sensory or motor neuropathy.
- Subject with history of GBS or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
- Subject with a current diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or solitary plasmacytoma.
- 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.
- The subject has had plasmapheresis within 14 days of initiating induction therapy.
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- Subject with clinical signs of meningeal involvement of multiple myeloma.
- 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).
- 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.
- 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).
- 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.
- 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.
- Known allergies to any of the study medications, their analogues, or excipients in the various formulations.
- 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.
- 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.
- 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.
Trial locations and contacts
69 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
69 sites in 2 countries
France64 sites, 64 recruiting
- Recruiting
CHU Amiens
Amiens
- Recruiting
CHU Angers
Angers
- Recruiting
Ch Annecy Genevois
Annecy
- Recruiting
Centre Hospitalier d'Argenteuil Victor Dupouy
Argenteuil
- Recruiting
Centre Hospitalier H. Duffaut
Avignon
- Recruiting
Centre hospitalier de la Côte Basque
Bayonne
- Recruiting
CHU Besançon
Besançon
- Recruiting
Centre Hospitalier Simone Veil
Blois
- Recruiting
Hôpital Avicenne
Bobigny
- Recruiting
CHU Bordeaux - Hopital Haut Lévêque - Centre F. Magendi
Bordeaux
- Recruiting
CH Fleyriat
Bourg-en-Bresse
- Recruiting
CHRU Brest - Hôpital A. Morvan
Brest
- Recruiting
CHU Caen - Côte de Nacre
Caen
- Recruiting
Centre Hospitalier William Morey
Chalon-sur-Saône
- Recruiting
CHMS Centre Hospitalier Métropole Savoie
Chambéry
- Recruiting
Hopital Louis Pasteur
Chartres
- Recruiting
Hôpital d'Instruction des Armées Percy
Clamart
- Recruiting
Chu Estaing
Clermont-Ferrand
- Recruiting
Centre Hospitalier Sud Francilien
Corbeil-Essonnes
- Recruiting
CHU Henri Mondor
Créteil
- Recruiting
CHU Dijon
Dijon
- Recruiting
Institut de cancérologie de Bourgogne
Dijon
- Recruiting
Centre Hospitalier de Dunkerque
Dunkirk
- Recruiting
CHU de Grenoble
Grenoble
- Recruiting
CHU de la Réunion Site SUD (Terre Sainte)
La Réunion
- Recruiting
CHD Vendée
La Roche-sur-Yon
- Recruiting
Hopital Monod
Le Havre
- Recruiting
CH Le mans
Le Mans
- Recruiting
CHRU Hôpital Claude Huriez
Lille
- Recruiting
Centre Hospitalier Universitaire (CHU) de Limoges
Limoges
- Recruiting
Centre Léon Bérard
Lyon, 69373
- Recruiting
Centre Hospitalier Lyon Sud
Lyon
- Recruiting
Grand Hopital Est Francilien (GHEF) Site de Meaux
Meaux
- Recruiting
Hôpital de Mercy (CHR Metz-Thionville)
Metz
- Recruiting
Centre de Recherche Clinique / GHT des Landes
Mont-de-Marsan
- Recruiting
Hopital Saint Eloi - CHU Montpellier
Montpellier
- Recruiting
Hôpital E. Muller
Mulhouse
- Recruiting
CHRU Hôpitaux de Brabois
Nancy
- Recruiting
CHRU Hôtel Dieu
Nantes
- Recruiting
Hôpital Archet 1
Nice
- Recruiting
CHU Carémeau, Institut de Cancérologie du Guard
Nîmes
- Recruiting
CHR Orléans
Orléans
- Recruiting
CHU Hôpital Saint Antoine
Paris
- Recruiting
Hôpital Cochin
Paris
- Recruiting
Hôpital Necker
Paris
- Recruiting
Hôpital Saint Louis
Paris
- Recruiting
La Pitié Salpêtrière
Paris
- Recruiting
Centre Hospitalier de Perigueux
Périgueux
- Recruiting
CH Saint Jean
Perpignan
- Recruiting
CHU Poitiers - Pôle régional de Cancérologie
Poitiers
- Recruiting
Centre hospitalier René Dubost
Pontoise
- Recruiting
Centre Hospitalier de Quimper Cornouaille
Quimper
- Recruiting
CHRU Hôpital de Pontchaillou
Rennes
- Recruiting
Centre Henri Becquerel
Rouen
- Recruiting
Centre Hospitalier Saint Brieuc
Saint-Brieuc
- Recruiting
Institut de Cancérologie Lucien Neuwirth
Saint-Priest
- Recruiting
Centre Hospitalier de Saint-Quentin
Saint-Quentin
- Recruiting
CHU Strasbourg
Strasbourg
- Recruiting
Centre hospitalier
Tarbes
- Recruiting
Pôle IUCT Oncopole CHU
Toulouse
- Recruiting
CHRU Hôpital Bretonneau - Centre Henry Kaplan
Tours
- Recruiting
CH Bretagne Atlantique Vannes et Auray - P. Chubert
Vannes
- Recruiting
CHV André Mignot - Université de Versailles
Versailles
- Recruiting
Gustave Roussy
Villejuif
Belgium5 sites, 5 recruiting
- Not yet recruiting
Institut Jules Bordet
Brussels, 1000
- Not yet recruiting
Cliniques Universitaires Saint Luc
Brussels, 1200
- Not yet recruiting
Grand Hopital Charleroi
Charleroi, 6000
- Not yet recruiting
CHU de Liège
Liège, 4000
- Not yet recruiting
CHU UCL Namur
Yvoir, 5530
About this study
Official title: A Phase 3, Open-label, Controlled, Randomized Study of Newly Diagnosed Multiple Myeloma Treatment, Designed to Evaluate the Efficacy and Safety of the Elranatamab-lenalidomide Combination as a Replacement for Chemotherapy Followed by Autologous Stem Cell Transplant in the Consolidation Phase, and to Compare Elranatamab With Standard of Care in the Maintenance Phase
This study is designed as a multicenter, randomized, parallel groups, open-label, phase 3 study in subjects with untreated newly diagnoses Multiple Myeloma eligible for ASCT.
824 patients will be enrolled in this study from approximately 70 study sites.
Read more
The 2 parts in the Treatment Phase are described below.
Part 1: Induction/ASCT/Consolidation Phase (1:1 Randomization)
After the screening period, patients will be randomly allocated (1:1) to either:
- Arm A (standard of care arm): standard induction therapy with 4 cycles of D-VRd, followed by HDCT (Melphalan) + ASCT, D-VRd consolidation therapy
- Arm B (experimental arm): standard induction therapy with 4 cycles of D-VRd, followed by elranatamab and lenalidomide consolidation therapy.
Part 2: Maintenance Phase (1:1 Re-randomization) Patients will be re-randomized (1:1) and will enter the Maintenance Phase upon completion of consolidation therapy.
- Arm C (standard of care arm): daratumumab + lenalidomide approx 2 years. Subjects with a negative MRD (for at least 12 months) after 24 cycles of daratumumab-lenalidomide will discontinue daratumumab and continue with lenalidomide monotherapy until disease progression, or study cut-off date (whichever occurs first).
Subjects who did not achieve MRD negativity for at least 12 months after 24 cycles of daratumumab-lenalidomide will continue to receive daratumumab-lenalidomide until:
- MRD negativity for at least 12 months is reached. Subjects will then continue with lenalidomide monotherapy until disease progression, or study cut-off date (whichever occurs first).
- Disease progression
- Or study cut-off date (whichever occurs first).
- Arm D (experimental arm): elranatamab. Approx 2 years. Subjects with a negative MRD (for at least 12 months) after receiving M22 administration of elranatamab will discontinue study treatment with elranatamab.
Subjects who did not achieve MRD negativity for at least 12 months after M22 elranatamab administration will continue to receive elranatamab, every 24 weeks, until MRD negativity for at least 12 months is reached, disease progression, or study cut-off date (whichever occurs first).
- Conditions
- Multiple Myeloma, Newly Diagnosed
- Being tested
- Elranatamab, Lenalidomide (Revlimid®), Daratumumab SC (Darzalex), Autologous Stem Cell Transplantation, Bortezomib (Velcade®)
- 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
Elranatamab is given to arm B patients in association with lenalidomide (for consolidation) and arm D patients in monotherapy (for maintenance) as experimental arms
Lenalidomide (Revlimid®)Drug
In association with daratumumab, bortezomib and dexamethasone (Arm A), in association with elranatamab (Arm B), and in combination with daratumumab in maintenance (Arm C)
Daratumumab SC (Darzalex)Drug
Daratumumab is given in association with bortezomib, lenalidomide and dexamethasone in induction therapy (all patients) and consolidation arm A
Autologous Stem Cell TransplantationProcedure or surgery
ASCT is performed in consolidation for Arm A patients after induction therapy with D-VRD
Bortezomib (Velcade®)Drug
Bortezomib is given in associtaion with daratumumab, lenalidomide and dexamethasone in induction (all patients) and consolidation Arm A
DexamethasoneDrug
Dexamethasone is given in association with daratumumab, bortezomib and lenalidomide in induction (all patients) and consolidation Arm A
| Study group | Role | What they receive |
|---|---|---|
| D-VRD induction, ASCT and D-VRD consolidation (arm A) | Active comparator | Standard induction therapy with 4 cycles of D-VRd, followed by HDCT (Melphalan) + ASCT, and 2 cycles of D-VRd consolidation therapy Receives: Drug: Lenalidomide (Revlimid®); Drug: Daratumumab SC (Darzalex); Procedure: Autologous Stem Cell Transplantation; Drug: Bortezomib (Velcade®); Drug: Dexamethasone |
| D-VRD induction followed by elranatamab and lenalidomide consolidation (arm B) | Experimental | Standard induction therapy with 4 cycles of D-VRd, followed by elranatamab and lenalidomide consolidation therapy. Receives: Drug: Elranatamab; Drug: Lenalidomide (Revlimid®); Drug: Daratumumab SC (Darzalex); Drug: Bortezomib (Velcade®); Drug: Dexamethasone |
| daratumumab + lenalidomide maintenance (Arm C) | Active comparator | Daratumumab + Lenalidomide for two years (maintenance) Receives: Drug: Lenalidomide (Revlimid®); Drug: Daratumumab SC (Darzalex) |
| elranatamab maintenance (Arm D) | Experimental | Elranatamab monotherapy for two years (maintenance) Receives: Drug: Elranatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 (induction/consolidation) from Randomization 1 (R1): to assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of Minimal Residual Disease (MRD) negativity rate
To assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of MRD negativity rate.
Measured: at end of consolidation, up to 36 months
Part 2 (maintenance) from Randomization 2 (R2): to assess whether maintenance therapy with elranatamab is superior to standard of care, in terms of Progression Free Survival (PFS).
To assess whether maintenance therapy with elranatamab is superior to standard of care, in terms of PFS.
Measured: from the date of second randomization to the date of confirmed PD (IMWG criteria,) or death from any cause, whichever came first, assessed up to 93 monts
Key secondary objectives: Part 1 (induction/consolidation) from R1: to assess whether consolidation therapy with elranatamab and lenalidomide is superior, in terms of PFS
To assess whether consolidation therapy with elranatamab and lenalidomide is superior, in terms of PFS
Measured: PFS defined as the time interval from the date of first randomization to the date of confirmed Progression Disease (IMWG criteria) or death from any cause, whichever occurs first., assessed up to 128 months
Key secondary objectives: Part I (induction/consolidation) from R1: to assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of Overal Survival (OS)
To assess whether consolidation therapy with elranatamab and lenalidomide is superior to standard of care, in terms of OS
Measured: up to 128 months
Secondary outcomes (8)
Part 1 (induction/consolidation) from R1: to assess the efficacy of consolidation therapy with elranatamab and lenalidomide compared to standard of care
To assess the efficacy of consolidation therapy with elranatamab and lenalidomide compared to standard of care: Overall response rate (ORR), Very good partial response (VGPR) rate, Complete response (CR) rate
Measured: End of consolidation phase, up to 36 months
Part 2 (maintenance) from R2: to assess the efficacy of maintenance therapy with elranatamab
To assess the efficacy of maintenance therapy with elranatamab:
- Overall response rate (ORR) in maintenance
- Very good partial response (VGPR) rate in maintenance
- Complete response (CR) rate in maintenance
Measured: end of maintenance, up to 58 months
assess safety & Tolerability during induction, and during consolidation and maintenance therapy: Adverse events (AE), serious Adrverse events (SAE) and And adverse events of special interest (AESI) rates - Incidence of Treatment-Emergent Adverse Events
To assess safety during induction, and during consolidation and maintenance therapy: AEs, SAE and AESI rates , Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured: through study completion, up to 128 months
Throughout the study to evaluate the impact of treatment on health-related Quality of Life (QoL) using Rework questionnaire
To evaluate the impact of treatment on health-related QoL: Rework questionnaire
Measured: through study completion, up to 128 months
Part 2 (maintenance) from Randomization 2 (R2): to assess the efficacy of maintenance therapy with elranatamab, Progression Free Survival 2 form Randomization 2
To assess the efficacy of maintenance therapy with elranatamab:
- PFS of subsequent/next treatment line (PFS2 from R2)
Measured: up to 128 months
Part 2 (maintenance) from R2: to assess the efficacy of maintenance therapy with elranatamab, in term of Minimal Residual Disease negativity
To assess the efficacy of maintenance therapy with elranatamab:
- MRD negativity at 12 months post R2
Measured: 12 months post R2, up to 71 months
Throughout the study: to evaluate the impact of treatment on health-related Quality of Life (QoL) using EQ-5D-5L
To evaluate the impact of treatment on health-related QoL: scale title :EQ-5D-5L , the minimum value is 0 and maximum value is 100 (100 corresponds to the best health that patient can imagine, 0 corresponds to the worst health that patient can imagine
Measured: Though study completion, an average of 11 years
Part 2 (maintenance) from R2: To assess the efficacy of maintenance therapy with elranatamab (OS R2)
To assess the efficacy of maintenance therapy with elranatamab:
- Overall survival from second randomization (OS R2)
Measured: up to 128 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start9 Jul 2025
- Primary completionMay 2036 (estimated)
- Study completionMay 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma, Newly DiagnosedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 824 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone du Myelome
- Sponsor type
- Research network
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Chanaz LOUNI, Study director, The Institute for Functional MedicineAurore PERROT, Prof, Principal investigator, IUCT Toulouse FranceCyrille TOUZEAU, Prof, Principal investigator, CHU Nantes France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918002
- Sponsor's protocol ID
- IFM 2025-01
- Other IDs
- 2024-516418-39-00
- Acronym
- ElLen
- Status last verified
- Sep 2026
- First submitted
- 10 Dec 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No