Actively Recruiting
Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM Patients
Led by Intergroupe Francophone du Myelome · Updated on 2026-04-02
824
Participants Needed
64
Research Sites
564 weeks
Total Duration
On this page
Sponsors
I
Intergroupe Francophone du Myelome
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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): lenalidomide * Arm D (experimental arm): elranatamab
CONDITIONS
Official Title
Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged over 18 years
- Provided voluntary written informed consent before any study procedures
- Newly diagnosed multiple myeloma eligible for high-dose chemotherapy and autologous stem cell transplantation
- Documented symptomatic multiple myeloma with measurable disease by specified laboratory and imaging criteria
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- Adequate laboratory values within 15 days before starting induction therapy, including hemoglobin, neutrophil count, liver enzymes, bilirubin, creatinine clearance, calcium, and platelet count
- Women of childbearing potential must have negative pregnancy tests before randomization and before starting induction therapy
You will not qualify if you...
- Previous systemic therapy for multiple myeloma (except limited corticosteroids during screening)
- Grade 3 or higher ongoing peripheral sensory or motor neuropathy
- History of Guillain-Barré syndrome or similar severe peripheral motor polyneuropathy
- Current diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, or solitary plasmacytoma
- Diagnosis of Waldenström's macroglobulinemia or other IgM M-protein conditions without plasma cell infiltration
- Plasmapheresis within 14 days before starting induction therapy
- Clinical signs of meningeal involvement by multiple myeloma
- Plasma cell leukemia or POEMS syndrome
- Any medical or psychiatric condition that could interfere with study participation or pose a hazard
- Significant cardiac disease including recent myocardial infarction, unstable angina, severe heart failure, uncontrolled arrhythmia, or QTc interval >470 msec
- Use of certain strong CYP1A2 or CYP3A inhibitors or inducers or herbal supplements within 14 days before induction therapy
- Known intolerance or allergies to study medications or their components
- Major surgery within 2 weeks before consent or planned during study participation
- Prior or concurrent invasive malignancy within 10 years except certain treated cancers without relapse
- Pregnant or breastfeeding women or those unwilling to use adequate contraception
- Known positive for HIV or active hepatitis A, B, or C infection not adequately controlled
- Active systemic or severe infections requiring intravenous antibiotics
- Gastrointestinal disorders impacting absorption of oral treatments
- Unable or unwilling to undergo antithrombotic prophylaxis
- Under guardianship, trusteeship, or deprived of freedom by judicial or administrative decision
AI-Screening
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Trial Site Locations
Total: 64 locations
1
CHU Amiens
Amiens, France
Actively Recruiting
2
CHU Angers
Angers, France
Actively Recruiting
3
Ch Annecy Genevois
Annecy, France
Actively Recruiting
4
Centre Hospitalier d'Argenteuil Victor Dupouy
Argenteuil, France
Actively Recruiting
5
Centre Hospitalier H. Duffaut
Avignon, France
Actively Recruiting
6
Centre hospitalier de la Côte Basque
Bayonne, France
Actively Recruiting
7
CHU Besançon
Besançon, France
Actively Recruiting
8
Centre Hospitalier Simone Veil
Blois, France
Not Yet Recruiting
9
Hôpital Avicenne
Bobigny, France
Not Yet Recruiting
10
CHU Bordeaux - Hopital Haut Lévêque - Centre F. Magendi
Bordeaux, France
Actively Recruiting
11
CH Fleyriat
Bourg-en-Bresse, France
Not Yet Recruiting
12
CHRU Brest - Hôpital A. Morvan
Brest, France
Actively Recruiting
13
CHU Caen - Côte de Nacre
Caen, France
Not Yet Recruiting
14
Centre Hospitalier William Morey
Chalon-sur-Saône, France
Actively Recruiting
15
CHMS Centre Hospitalier Métropole Savoie
Chambéry, France
Not Yet Recruiting
16
Hopital Louis Pasteur
Chartres, France
Not Yet Recruiting
17
Hôpital d'Instruction des Armées Percy
Clamart, France
Not Yet Recruiting
18
Chu Estaing
Clermont-Ferrand, France
Actively Recruiting
19
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
Actively Recruiting
20
CHU Henri Mondor
Créteil, France
Not Yet Recruiting
21
CHU Dijon
Dijon, France
Not Yet Recruiting
22
Institut de cancérologie de Bourgogne
Dijon, France
Actively Recruiting
23
Centre Hospitalier de Dunkerque
Dunkirk, France
Actively Recruiting
24
CHU de Grenoble
Grenoble, France
Actively Recruiting
25
CHU de la Réunion Site SUD (Terre Sainte)
La Réunion, France
Not Yet Recruiting
26
CHD Vendée
La Roche-sur-Yon, France
Actively Recruiting
27
Hopital Monod
Le Havre, France
Actively Recruiting
28
CH Le mans
Le Mans, France
Actively Recruiting
29
CHRU Hôpital Claude Huriez
Lille, France
Not Yet Recruiting
30
Centre Hospitalier Universitaire (CHU) de Limoges
Limoges, France
Actively Recruiting
31
Centre Hospitalier Lyon Sud
Lyon, France
Actively Recruiting
32
Grand Hopital Est Francilien (GHEF) Site de Meaux
Meaux, France
Not Yet Recruiting
33
Hôpital de Mercy (CHR Metz-Thionville)
Metz, France
Actively Recruiting
34
Centre de Recherche Clinique / GHT des Landes
Mont-de-Marsan, France
Actively Recruiting
35
Hopital Saint Eloi - CHU Montpellier
Montpellier, France
Actively Recruiting
36
Hôpital E. Muller
Mulhouse, France
Actively Recruiting
37
CHRU Hôpitaux de Brabois
Nancy, France
Actively Recruiting
38
CHRU Hôtel Dieu
Nantes, France
Actively Recruiting
39
Hôpital Archet 1
Nice, France
Actively Recruiting
40
CHU Carémeau, Institut de Cancérologie du Guard
Nîmes, France
Not Yet Recruiting
41
CHR Orléans
Orléans, France
Not Yet Recruiting
42
CHU Hôpital Saint Antoine
Paris, France
Not Yet Recruiting
43
Hôpital Cochin
Paris, France
Actively Recruiting
44
Hôpital Necker
Paris, France
Not Yet Recruiting
45
Hôpital Saint Louis
Paris, France
Not Yet Recruiting
46
La Pitié Salpêtrière
Paris, France
Not Yet Recruiting
47
CH Saint Jean
Perpignan, France
Not Yet Recruiting
48
Centre Hospitalier de Perigueux
Périgueux, France
Actively Recruiting
49
CHU Poitiers - Pôle régional de Cancérologie
Poitiers, France
Actively Recruiting
50
Centre hospitalier René Dubost
Pontoise, France
Actively Recruiting
51
Centre Hospitalier de Quimper Cornouaille
Quimper, France
Actively Recruiting
52
Hôpital Robert Debré
Reims, France
Not Yet Recruiting
53
CHRU Hôpital de Pontchaillou
Rennes, France
Actively Recruiting
54
Centre Henri Becquerel
Rouen, France
Actively Recruiting
55
Centre Hospitalier Saint Brieuc
Saint-Brieuc, France
Actively Recruiting
56
Institut de Cancérologie Lucien Neuwirth
Saint-Priest, France
Actively Recruiting
57
Centre Hospitalier de Saint-Quentin
Saint-Quentin, France
Actively Recruiting
58
CHU Strasbourg
Strasbourg, France
Not Yet Recruiting
59
Centre hospitalier
Tarbes, France
Actively Recruiting
60
Pôle IUCT Oncopole CHU
Toulouse, France
Actively Recruiting
61
CHRU Hôpital Bretonneau - Centre Henry Kaplan
Tours, France
Actively Recruiting
62
CH Bretagne Atlantique Vannes et Auray - P. Chubert
Vannes, France
Actively Recruiting
63
CHV André Mignot - Université de Versailles
Versailles, France
Actively Recruiting
64
Gustave Roussy
Villejuif, France
Not Yet Recruiting
Research Team
L
Léa Tabone, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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