Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM Patients (ElLen)

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.

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).

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma, Newly Diagnosed
• Intervention / Treatment: Drug: Daratumumab SC (Darzalex); Procedure: Autologous Stem Cell Transplantation; Drug: Bortezomib (Velcade®); Drug: Dexamethasone; Drug: Elranatamab; Drug: Lenalidomide (Revlimid®)

• Study Type: Interventional
• Enrollment (Estimated): 824
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Léa Tabone, PharmD; Phone Number: 0140212404; Email: l.tabone@myelome.fr

Study Locations

• France
  • Amiens, France
    • Recruiting
    • CHU Amiens
  • Angers, France
    • Recruiting
    • CHU Angers
  • Annecy, France
    • Recruiting
    • Ch Annecy Genevois
  • Argenteuil, France
    • Recruiting
    • Centre Hospitalier d'Argenteuil Victor Dupouy
  • Avignon, France
    • Recruiting
    • Centre Hospitalier H. Duffaut
  • Bayonne, France
    • Recruiting
    • Centre Hospitalier de la Cote Basque
  • Besançon, France
    • Recruiting
    • CHU Besançon
  • Blois, France
    • Not yet recruiting
    • Centre Hospitalier Simone Veil
  • Bobigny, France
    • Recruiting
    • Hôpital Avicenne
  • Bordeaux, France
    • Recruiting
    • CHU Bordeaux - Hopital Haut Lévêque - Centre F. Magendi
  • Bourg-en-Bresse, France
    • Recruiting
    • CH Fleyriat
  • Brest, France
    • Recruiting
    • CHRU Brest - Hôpital A. Morvan
  • Caen, France
    • Recruiting
    • CHU Caen - Côte de Nacre
  • Chalon-sur-Saône, France
    • Recruiting
    • Centre Hospitalier William Morey
  • Chambéry, France
    • Recruiting
    • CHMS Centre Hospitalier Métropole Savoie
  • Chartres, France
    • Not yet recruiting
    • Hopital Louis Pasteur
  • Clamart, France
    • Recruiting
    • Hopital D'Instruction Des Armees Percy
  • Clermont-Ferrand, France
    • Recruiting
    • CHU Estaing
  • Corbeil-Essonnes, France
    • Recruiting
    • Centre Hospitalier Sud Francilien
  • Créteil, France
    • Recruiting
    • CHU Henri Mondor
  • Dijon, France
    • Recruiting
    • CHU Dijon
  • Dijon, France
    • Recruiting
    • Institut de Cancérologie de Bourgogne
  • Dunkirk, France
    • Recruiting
    • Centre Hospitalier de Dunkerque
  • Grenoble, France
    • Recruiting
    • CHU de Grenoble
  • La Roche-sur-Yon, France
    • Recruiting
    • CHD Vendee
  • La Réunion, France
    • Recruiting
    • CHU de la Réunion Site SUD (Terre Sainte)
  • Le Havre, France
    • Recruiting
    • Hopital Monod
  • Le Mans, France
    • Recruiting
    • CH Le mans
  • Lille, France
    • Recruiting
    • CHRU Hôpital Claude Huriez
  • Limoges, France
    • Recruiting
    • Centre Hospitalier Universitaire (CHU) de Limoges
  • Lyon, France
    • Recruiting
    • Centre Hospitalier Lyon Sud
  • Meaux, France
    • Recruiting
    • Grand Hopital Est Francilien (GHEF) Site de Meaux
  • Metz, France
    • Recruiting
    • Hôpital de Mercy (CHR Metz-Thionville)
  • Mont-de-Marsan, France
    • Recruiting
    • Centre de Recherche Clinique / GHT des Landes
  • Montpellier, France
    • Recruiting
    • Hopital Saint Eloi - CHU Montpellier
  • Mulhouse, France
    • Recruiting
    • Hôpital E. Muller
  • Nancy, France
    • Recruiting
    • CHRU Hôpitaux de Brabois
  • Nantes, France
    • Recruiting
    • CHRU Hôtel Dieu
  • Nice, France
    • Recruiting
    • Hôpital Archet 1
  • Nîmes, France
    • Not yet recruiting
    • CHU Carémeau, Institut de Cancérologie du Guard
  • Orléans, France
    • Recruiting
    • CHR Orléans
  • Paris, France
    • Recruiting
    • Hopital Cochin
  • Paris, France
    • Recruiting
    • Hopital Saint Louis
  • Paris, France
    • Recruiting
    • Hôpital Necker
  • Paris, France
    • Recruiting
    • La Pitié Salpêtrière
  • Paris, France
    • Recruiting
    • CHU Hopital Saint Antoine
  • Perpignan, France
    • Not yet recruiting
    • CH Saint Jean
  • Poitiers, France
    • Recruiting
    • CHU Poitiers - Pôle régional de Cancérologie
  • Pontoise, France
    • Recruiting
    • Centre hospitalier René Dubost
  • Périgueux, France
    • Recruiting
    • Centre Hospitalier de Perigueux
  • Quimper, France
    • Recruiting
    • Centre Hospitalier de Quimper Cornouaille
  • Reims, France
    • Not yet recruiting
    • Hôpital Robert Debré
  • Rennes, France
    • Recruiting
    • CHRU Hopital de Pontchaillou
  • Rouen, France
    • Recruiting
    • Centre Henri Becquerel
  • Saint-Brieuc, France
    • Recruiting
    • Centre Hospitalier Saint Brieuc
  • Saint-Priest, France
    • Recruiting
    • Institut de Cancérologie Lucien Neuwirth
  • Saint-Quentin, France
    • Recruiting
    • Centre Hospitalier de Saint-Quentin
  • Strasbourg, France
    • Not yet recruiting
    • CHU Strasbourg
  • Tarbes, France
    • Recruiting
    • Centre Hospitalier
  • Toulouse, France
    • Recruiting
    • Pôle IUCT Oncopole CHU
  • Tours, France
    • Recruiting
    • CHRU Hôpital Bretonneau - Centre Henry Kaplan
  • Vannes, France
    • Recruiting
    • CH Bretagne Atlantique Vannes et Auray - P. Chubert
  • Versailles, France
    • Recruiting
    • CHV André Mignot - Université de Versailles
  • Villejuif, France
    • Recruiting
    • Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: D-VRD induction, ASCT and D-VRD consolidation (arm A); Standard induction therapy with 4 cycles of D-VRd, followed by HDCT (Melphalan) + ASCT, and 2 cycles of D-VRd consolidation therapy	Drug: Daratumumab SC (Darzalex); Daratumumab is given in association with bortezomib, lenalidomide and dexamethasone in induction therapy (all patients) and consolidation arm A; Procedure: Autologous Stem Cell Transplantation; ASCT is performed in consolidation for Arm A patients after induction therapy with D-VRD; Drug: Bortezomib (Velcade®); Bortezomib is given in associtaion with daratumumab, lenalidomide and dexamethasone in induction (all patients) and consolidation Arm A; Drug: Dexamethasone; Dexamethasone is given in association with daratumumab, bortezomib and lenalidomide in induction (all patients) and consolidation Arm A; Drug: Lenalidomide (Revlimid®); In association with daratumumab, bortezomib and dexamethasone (Arm A), in association with elranatamab (Arm B), and in combination with daratumumab in maintenance (Arm C)
Experimental: D-VRD induction followed by elranatamab and lenalidomide consolidation (arm B); Standard induction therapy with 4 cycles of D-VRd, followed by elranatamab and lenalidomide consolidation therapy.	Drug: Daratumumab SC (Darzalex); Daratumumab is given in association with bortezomib, lenalidomide and dexamethasone in induction therapy (all patients) and consolidation arm A; Drug: Bortezomib (Velcade®); Bortezomib is given in associtaion with daratumumab, lenalidomide and dexamethasone in induction (all patients) and consolidation Arm A; Drug: Dexamethasone; Dexamethasone is given in association with daratumumab, bortezomib and lenalidomide in induction (all patients) and consolidation Arm A; Drug: Elranatamab; Elranatamab is given to arm B patients in association with lenalidomide (for consolidation) and arm D patients in monotherapy (for maintenance) as experimental arms; Drug: Lenalidomide (Revlimid®); In association with daratumumab, bortezomib and dexamethasone (Arm A), in association with elranatamab (Arm B), and in combination with daratumumab in maintenance (Arm C)
Experimental: elranatamab maintenance (Arm D); Elranatamab monotherapy for two years (maintenance)	Drug: Elranatamab; Elranatamab is given to arm B patients in association with lenalidomide (for consolidation) and arm D patients in monotherapy (for maintenance) as experimental arms
Active Comparator: daratumumab + lenalidomide maintenance (Arm C); Daratumumab + Lenalidomide for two years (maintenance)	Drug: Daratumumab SC (Darzalex); Daratumumab is given in association with bortezomib, lenalidomide and dexamethasone in induction therapy (all patients) and consolidation arm A; Drug: Lenalidomide (Revlimid®); In association with daratumumab, bortezomib and dexamethasone (Arm A), in association with elranatamab (Arm B), and in combination with daratumumab in maintenance (Arm C)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	up to 128 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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]	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	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)	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	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	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)	up to 128 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
EXPLORATORY OBJECTIVES: to assess the impact of genomic markers (from Next generation sequencing (NGS) and Whole Genome Sequencing (WGS)) on outcome	To assess the impact of genomic markers (from NGS and WGS) on outcome: MRD negativity rate as determined by NGS with a sensitivity of at least 10-5 - PFS1 and OS	up to 128 months
EXPLORATORY OBJECTIVES: to assess Immune mechanisms predicting Elra-Len vs ASCT efficacy	Impact of the microenvironment (Immune mechanisms predicting Elra-Len vs ASCT efficacy) according to outcome (MRD, PFS and OS) rates	up to 128 months
EXPLORATORY OBJECTIVES: to assess the impact of PET imaging parameters/variables on outcome	rate of PET imaging positive / negative according to outcome (MRD, PFS and OS) rates	End of consolidation phase, up to 36 months
EXPLORATORY OBJECTIVES: To determine influence of M-component measurement assessed by mass spectrometry on outcome	To determine influence of M-component measurement assessed by mass spectrometry on outcome	up to 128 months
EXPLORATORY OBJECTIVES: To determine influence of circulating tumor cells on outcome in term of PFS1 and OS	To determine influence of circulating tumor cells on outcome in term of PFS1 and OS	up to 128 months
Exploratory objective :To evaluate the pharmacokinetics (PK) of elranatamab	Predose and postdose concentrations of elranatamab	up to 128 months
Exploratory objective : To evaluate the immunogenicity of elranatamab	To evaluate the immunogenicity of elranatamab	up to 128 months
Exploratory objective :To explore correlations between elranatamab exposure and efficacy, safety and biomarker endpoints, if data allow	To explore correlations between elranatamab exposure and efficacy, safety and biomarker endpoints, if data allow	up to 128 months
exploratory objective : assess treatment discontinuation rates	To assess treatment discontinuation rates	up to 128 months

Collaborators and Investigators

• Sponsor: Intergroupe Francophone du Myelome
• Collaborators: Pfizer
• Investigators: Study Director: Chanaz LOUNI, The Institute for Functional Medicine; Principal Investigator: Aurore PERROT, Prof, IUCT Toulouse France; Principal Investigator: Cyrille TOUZEAU, Prof, CHU Nantes France

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2025
• Primary Completion (Estimated): May 1, 2036
• Study Completion (Estimated): May 1, 2036

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Polycyclic Compounds; Piperidines; Inorganic Chemicals; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Boronic Acids; Acids, Noncarboxylic; Acids; Boron Compounds; Pyrazines; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Lenalidomide; Bortezomib; Dexamethasone; daratumumab
• Other Study ID Numbers: IFM 2025-01; 2024-516418-39-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes