Actively Recruiting
Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma
Led by Regeneron Pharmaceuticals · Updated on 2026-04-20
387
Participants Needed
40
Research Sites
751 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose of this study is to learn about the safety of linvoseltamab and to find out what is the best dose of linvoseltamab to give to patients with multiple myeloma and to look for any signs that linvoseltamab can effectively treat cancer. The study is looking at several other research questions, including: * Side effects that may be experienced by people receiving linvoseltamab * How linvoseltamab works in the body * How much linvoseltamab is present in the blood * How linvoseltamab may work to treat cancer
CONDITIONS
Official Title
Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- Confirmed diagnosis of active Multiple Myeloma by International Myeloma Working Group diagnostic criteria
- Myeloma that can be evaluated for response based on 2016 IMWG response criteria
- For Phase 1, Part 1: Patients with multiple myeloma who have exhausted all meaningful treatment options, including progression after or intolerance to at least 3 lines of therapy with a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, or progression after anti-CD38 antibody and double refractory to a proteasome inhibitor and an immunomodulatory agent
- For Phase 1, Part 2: Patients with progression after at least 3 prior therapies including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody, or triple-refractory patients
- For Phase 2 Cohorts 1 and 2: Patients with progression after at least 3 prior therapies including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody, or triple-refractory patients
- For Phase 2 Cohort 3: Patients with progression after at least 3 prior therapies including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody, or triple-refractory patients
- Patients who relapsed after BCMA-directed CAR-T therapy must have had a partial response or better and at least 60 days since last CAR-T treatment excluding corticosteroids
You will not qualify if you...
- Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis (excluding myeloma-associated amyloidosis), Waldenström macroglobulinemia, or POEMS syndrome
- Known brain lesions or meningeal involvement from multiple myeloma
- Cardiac ejection fraction below 40% by echocardiogram or multi-gated acquisition scan
- Prior treatment with BCMA-directed immunotherapies including BCMA bispecific antibodies and BiTEs (except BCMA antibody-drug conjugates and CAR-T therapy in Phase 2 Cohort 3)
- History of allogeneic stem cell transplantation at any time
- Autologous stem cell transplantation within 12 weeks before starting study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Active, Not Recruiting
2
Moffitt Cancer Center - McKinley Drive
Tampa, Florida, United States, 33612
Actively Recruiting
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Indiana University_Michigan Street
Indianapolis, Indiana, United States, 46202
Active, Not Recruiting
5
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
Actively Recruiting
6
C. S. Mott_University of Michigan
Ann Arbor, Michigan, United States, 48109
Active, Not Recruiting
7
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, United States, 48201
Active, Not Recruiting
8
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Active, Not Recruiting
9
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
10
Columbia University Medical Center
New York, New York, United States, 10032
Active, Not Recruiting
11
Ohio State University James Cancer Hospital
Columbus, Ohio, United States, 43210
Actively Recruiting
12
Oregon Health and Science University (OHSU) Marquam Hill Campus
Portland, Oregon, United States, 97239
Actively Recruiting
13
University of Texas MD Anderson Clinic
Houston, Texas, United States, 77030
Active, Not Recruiting
14
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
15
ZNA Psychiatrisch Ziekenhuis Stuivenberg
Antwerp, Belgium, 2060
Actively Recruiting
16
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
17
Universitatsklinikum Essen
Essen, North Rhine-Westphalia, Germany, 45147
Completed
18
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, Rhineland-Palatinate, Germany, 55131
Completed
19
Universitatsklinikum Wurzburg
Würzburg, Germany, 6 97080
Completed
20
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, Japan, 466-8650
Completed
21
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan, 467-8602
Actively Recruiting
22
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
23
Gunma University Hospital
Maebashi, Gunma, Japan, 371-8511
Actively Recruiting
24
Ibaraki Prefectural Central Hospital
Kasama-shi, Ibaraki, Japan, 309-1793
Actively Recruiting
25
University Hospital Kyoto Prefectural Univ of Medicine
Kyoto, Kyoto, Japan, 602-8566
Actively Recruiting
26
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan, 350-1298
Completed
27
Tokushima Prefectural Central Hospital
Tokushima, Tokushima, Japan, 770-8539
Actively Recruiting
28
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, Japan, 150-8935
Completed
29
Keio University Hospital
Tokyo, Japan, 160-8582
Actively Recruiting
30
National Cancer Center Korea
Goyang, South Korea, 10408
Actively Recruiting
31
Seoul National University Cancer Hospital
Seoul, South Korea, 03080
Actively Recruiting
32
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
33
Yonsei University College of Medicine, Severance Hospital
Seoul, South Korea, 3722
Actively Recruiting
34
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain, 08041
Actively Recruiting
35
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
36
Universitary Hospital La Princesa
Madrid, Salamanca, Spain, 28006
Actively Recruiting
37
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
38
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
39
Hospital Clinico Universitario de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
40
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Withdrawn
Research Team
C
Clinical Trial Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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