Actively Recruiting
A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant
Led by European Myeloma Network B.V. · Updated on 2026-03-25
1000
Participants Needed
59
Research Sites
570 weeks
Total Duration
On this page
Sponsors
E
European Myeloma Network B.V.
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible). The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.
CONDITIONS
Official Title
A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria
- Not eligible for high-dose chemotherapy and autologous stem cell transplantation
- Measurable multiple myeloma disease as defined in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Clinical laboratory values within specified ranges as required by the protocol
You will not qualify if you...
- International Myeloma Working Group Frailty Index score of 2, except if score is 2 based on age alone
- Declined transplant due to personal choice
- Non-secretory multiple myeloma, active plasma cell leukemia, or known amyloidosis including AL amyloidosis with myeloma, other forms of amyloidosis, Waldenstr�f6m macroglobulinemia, or POEMS syndrome
- Prior therapies for MGUS, smoldering multiple myeloma, or multiple myeloma except focal radiation or short corticosteroid courses
- Receiving or having received investigational agents or cell therapies targeting multiple myeloma
- Central nervous system involvement with multiple myeloma, progressive multifocal leukoencephalopathy, recent seizure or stroke history within 12 months
- Uncontrolled other illnesses
- Known contraindications to daratumumab or lenalidomide
- History of allogeneic stem cell or solid organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 59 locations
1
Flinders Medical Centre
Adelaide, Australia
Actively Recruiting
2
Box Hill Hospital
Box Hill, Australia
Actively Recruiting
3
Canberra Hospital
Canberra, Australia
Actively Recruiting
4
Barwon Health, University Hospital Geelong
Geelong, Australia
Actively Recruiting
5
Austin Hospital
Heidelberg, Australia
Actively Recruiting
6
Nepean Cancer Centre
Kingswood, Australia
Actively Recruiting
7
Northern Hospital
Melbourne, Australia
Actively Recruiting
8
Sunshine Coast Health
Sunshine Coast, Australia
Actively Recruiting
9
Ordensklinikum Linz
Linz, Austria
Actively Recruiting
10
Klinik Ottakring
Vienna, Austria
Actively Recruiting
11
University Hospital Centre Zagreb - Clinic for Internal Medicine
Zagreb, Croatia
Actively Recruiting
12
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia
Actively Recruiting
13
University Hospital Olomouc
Olomouc, Czechia
Actively Recruiting
14
Fakultni Nemocnice Ostrava
Ostrava, Czechia
Actively Recruiting
15
Fakultni Nemocnice Plzen
Pilsen, Czechia
Actively Recruiting
16
Aarhus Universitetshospital
Aarhus, Denmark
Actively Recruiting
17
North Estonia Medical Centre Foundation
Tallinn, Estonia
Actively Recruiting
18
Tartu University Hospital
Tartu, Estonia
Actively Recruiting
19
Helsinki University Hospital Comprehensive Cancer Center
Helsinki, Finland
Actively Recruiting
20
Kuopio University Hospital
Kuopio, Finland
Actively Recruiting
21
Universitaetsmedizin Greifswald
Greifswald, Germany
Actively Recruiting
22
Universitaetsklinikum Schleswig-Holstein -Campus Luebeck - Klinik fuer Haematologie und Onkologie
Lübeck, Germany
Actively Recruiting
23
University Hospital of Würzburg
Würzburg, Germany
Actively Recruiting
24
University Hospital of Alexandroupolis
Alexandroupoli, Greece
Actively Recruiting
25
Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens
Athens, Greece
Actively Recruiting
26
Evaggelismos Hospital
Athens, Greece
Actively Recruiting
27
Theagenion Cancer Hospital
Thessaloniki, Greece
Actively Recruiting
28
Cork University Hospital
Cork, Ireland
Actively Recruiting
29
Beaumont Hospital
Dublin, Ireland
Actively Recruiting
30
University Hospital Limerick - Department of Haematology
Limerick, Ireland
Actively Recruiting
31
AOU Ospedali Riuniti di Ancona
Ancona, Italy
Actively Recruiting
32
Azienda Ospedaliera Santa Croce e Carle - Ematologia
Cuneo, Italy
Actively Recruiting
33
A.O.U. Careggi
Florence, Italy
Actively Recruiting
34
IRCCS Ospedale Policlinico San Martino
Genova, Italy
Actively Recruiting
35
Ospedale di Legnano, ASST Ovest Milanese
Legnano, Italy
Actively Recruiting
36
Meldola-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola, Italy
Actively Recruiting
37
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Actively Recruiting
38
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda - Oncologia
Milan, Italy
Actively Recruiting
39
Azienda USL IRCCS Di Reggio Emilia
Reggio, Italy
Actively Recruiting
40
Ospedale "Infermi" di Rimini
Rimini, Italy
Actively Recruiting
41
I.R.C.C.S. Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
Actively Recruiting
42
Erasmus MC
Rotterdam, Netherlands
Actively Recruiting
43
Stavanger University Hospital
Stavanger, Norway
Actively Recruiting
44
St. Olavs hospital HF
Trondheim, Norway
Actively Recruiting
45
Vestfold Hospital Trust
Tønsberg, Norway
Actively Recruiting
46
CHUC
Coimbra, Portugal
Actively Recruiting
47
Hospital da Luz Lisboa
Lisbon, Portugal
Actively Recruiting
48
Institut Catala D'oncologia (Badalona)
Badalona, Spain
Actively Recruiting
49
Hospital Clinic De Barcelona - Myeloma and Amyloidosis Unit
Barcelona, Spain
Actively Recruiting
50
Hospital Quirón Salud Madrid
Madrid, Spain
Actively Recruiting
51
Hospital Universitario Marques De Valdecilla -Hematology and Hemotherapy Service
Santander, Spain
Actively Recruiting
52
Hospital Universitario la Fe, Valencia
Valencia, Spain
Actively Recruiting
53
Skåne University Hospital, Region Skåne
Lund, Sweden
Actively Recruiting
54
Universitaetsspital Basel - Zentrum fur Hamato-Onkologie
Basel, Switzerland
Actively Recruiting
55
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Actively Recruiting
56
Ankara University Faculty of Medicine, Department of Hematology
Ankara, Turkey (Türkiye)
Actively Recruiting
57
Liv Hospital Ankara
Ankara, Turkey (Türkiye)
Actively Recruiting
58
Ege Universitesi Tip Fakultesi - Hematology
Izmir, Turkey (Türkiye)
Actively Recruiting
59
Ege University Medicine Faculty, Izmir
Izmir, Turkey (Türkiye)
Actively Recruiting
Research Team
S
Silvia Villa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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