Actively Recruiting
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Led by Regeneron Pharmaceuticals · Updated on 2026-05-13
149
Participants Needed
32
Research Sites
619 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is researching an experimental drug called linvoseltamab (called "study drug"). The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are eligible for high dose chemotherapy with autologous stem cell transplantation (transplant-eligible) or ineligible for autologous stem cell transplantation (transplant-ineligible). The aim of this clinical trial is to study the safety, tolerability (how the body reacts to the drug), and effectiveness (tumor shrinkage) of linvoseltamab in study participants with NDMM as a first step in determining if the study drug has a role in the treatment of NDMM. This study consists of 2 phases: * In Phase 1 Parts A and B, the study drug will be given to participants to study the side effects of the study drug and to establish the regimen (initial doses and full dose) of the study drug to be given to participants in Phase 2. * In Phase 1 Part C, the study drug will be given to participants to study the side effects when using different initial doses of the study drug. * In Phase 2, the study drug will be given to more participants to continue to assess the side effects of the study drug and to evaluate the activity of the study drug to shrink the tumor (multiple myeloma) in participants with NDMM. The study is looking at several research questions, including: * What side effects may happen from taking linvoseltamab? * What the right dosing regimen is for linvoseltamab? * How many participants treated with linvoseltamab have improvement of their disease and for how long? * The effects of linvoseltamab study treatment before and after transplant * How much linvoseltamab is in the blood at different times? * Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects).
CONDITIONS
Official Title
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Confirmed diagnosis of symptomatic Multiple Myeloma by International Myeloma Working Group criteria
- Response-evaluable myeloma according to 2016 IMWG response criteria
- No prior therapy for multiple myeloma except emergent or palliative radiation and up to 1 month of single-agent corticosteroids
- Evidence of adequate bone marrow, liver, kidney, and heart function as defined in the protocol
- Age under 70 years and adequate organ function to be considered transplant-eligible
You will not qualify if you...
- Currently receiving any investigational agent active against multiple myeloma or targeting APRIL/TACI/BCMA axis
- Known central nervous system involvement with multiple myeloma, suspected or known progressive multifocal leukoencephalopathy, neurocognitive conditions, movement disorders, or seizure within 12 months prior to enrollment
- Rapidly progressive symptomatic disease requiring urgent chemotherapy
- Diagnosis of non-secretory multiple myeloma, active plasma cell leukemia, primary light-chain amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome
- Other protocol-defined criteria as applicable
AI-Screening
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Trial Site Locations
Total: 32 locations
1
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
Actively Recruiting
2
UC Irvine Health
Orange, California, United States, 92868
Actively Recruiting
3
Colorado Blood Cancer Institute/SCRI
Denver, Colorado, United States, 80218
Actively Recruiting
4
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Actively Recruiting
5
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
6
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
7
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
8
Perlmutter Cancer Center
New York, New York, United States, 10016
Actively Recruiting
9
Columbia University _ New York Presbyterian
New York, New York, United States, 10032
Actively Recruiting
10
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Actively Recruiting
11
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
12
Duke University Health System (DUHS)
Durham, North Carolina, United States, 27705
Actively Recruiting
13
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
14
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, Vienne, France, 86021
Actively Recruiting
15
CHU De Lille
Lille, France, 59000
Not Yet Recruiting
16
Centre Hospitalier Universitaire (CHU) Montpellier
Montpellier, France, 342950
Actively Recruiting
17
Hopital Saint Louis
Paris, France, 75010
Actively Recruiting
18
University Hospitals Pitie Salpetriere - Charles Foix
Paris, France, 75651
Actively Recruiting
19
Hopital Prive d'Antony
Antony, Île-de-France Region, France, 92160
Actively Recruiting
20
Hopital Necker
Paris, Île-de-France Region, France, 75015
Actively Recruiting
21
Gustave Roussy
Villejuif, Île-de-France Region, France, 94800
Actively Recruiting
22
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Actively Recruiting
23
Hospital Universitario Quiron Salud Madrid
Pozuelo de Alarcón, Madrid, Spain, 28223
Actively Recruiting
24
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
25
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
26
Hospital General Universitario Doctor Balmis Alicante
Alicante, Valencia, Spain, 03010
Actively Recruiting
27
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
28
Institut Catala dOncologia (ICO Hospitalet)
Barcelona, Spain, 08908
Actively Recruiting
29
Universitary Hospital La Princesa
Madrid, Spain, 28006
Actively Recruiting
30
Clinica Universidad de Navarra - Madrid
Madrid, Spain, 28027
Actively Recruiting
31
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
32
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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