Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT03761108
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
387 participants
INTERVENTIONAL
2019-01-23
2033-06-16
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Linvoseltamab - Phase 1
Phase 1 has two parts. Part 1, consists of linvoseltamab intravenous (IV) dose escalation and Part 2, consists of subcutaneous (SC) administration.
Note: subcutaneous (SC) administration is not applicable for US.
Linvoseltamab
Administered per the protocol
Linvoseltamab - Phase 2 - Cohort 1
Low Dose of linvoseltamab IV monotherapy.
Linvoseltamab
Administered per the protocol
Linvoseltamab - Phase 2 - Cohort 2
High Dose of linvoseltamab IV monotherapy.
Linvoseltamab
Administered per the protocol
Linvoseltamab - Phase 2 - Cohort 3
Anti-interleukin (IL)-6 receptor (R) prophylactic therapy followed by high dose of IV linvoseltamab monotherapy
Note: Cohort 3 is not applicable for US.
Linvoseltamab
Administered per the protocol
Interventions
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Linvoseltamab
Administered per the protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Confirmed diagnosis of active Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria
3. Patients must have myeloma that is response-evaluable according to the 2016 IMWG response criteria as defined in the protocol.
* Phase 1, Part 1 (Dose Escalation): Patients with MM who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease or intolerance of the therapy and including either:
a. Progression on or after at least 3 lines of therapy, or intolerance of therapy, including a proteasome inhibitor, an Immunomodulatory agent (IMiD), and an anti-CD38 antibody, OR b. Progression on or after an anti-CD38 antibody and have disease that is "double refractory" to a proteasome inhibitor and an IMiD, or intolerance of therapy. The anti-CD38 antibody may have been administered alone or in combination with another agent such as a proteasome inhibitor (PI). Refractory disease is defined as lack of response or relapse within 60 days of last treatment.
* Phase 1, Part 2 (SC Administration): Patients with MM whose disease meets the following criteria:
a. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR b. Patients must be triple-refractory, defined as being refractory to prior treatment with at least 1 anti-CD38 antibody, a proteasome inhibitor, and an IMiD.
* Phase 2 (Cohorts 1 and 2):
Patients with MM whose disease meets the following criteria:
a. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR b. Patients must be triple- refractory, defined as being refractory\* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody.
* Phase 2 (Cohort 3):
Patients with MM whose disease meets the following criteria:
1. Progression on or after at least 3 prior lines of therapy including a(n) PI, IMiD, and anti-CD38 antibody, OR
2. Patients must be triple- refractory, defined as being refractory\* to prior treatment with at least 1 PI, 1 IMiD, and an anti-CD38 antibody.
* Refractory disease is defined as progression during treatment or within 60 days after completion of therapy, or \<25% response to therapy.
AND, for ALL patients, if they have relapsed after a BCMA-directed CAR-T cellular therapy then:
• Treatment with a CAR-T must have been associated with a response of PR or better, and
• If CAR-T cellular therapy was the most recent prior therapy, excluding corticosteroids, then treatment must have been a minimum of 60 days prior to treatment with linvoseltamab.
Exclusion Criteria
5\. History of allogeneic stem cell transplantation at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Moffitt Cancer Center - McKinley Drive
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Indiana University_Michigan Street
Indianapolis, Indiana, United States
Norton Cancer Institute
Louisville, Kentucky, United States
C. S. Mott_University of Michigan
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Ohio State University James Cancer Hospital
Columbus, Ohio, United States
Oregon Health and Science University (OHSU) Marquam Hill Campus
Portland, Oregon, United States
University of Texas MD Anderson Clinic
Houston, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
ZNA Psychiatrisch Ziekenhuis Stuivenberg
Antwerp, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Universitatsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, Rhineland-Palatinate, Germany
Universitatsklinikum Wurzburg
Würzburg, , Germany
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Ibaraki Prefectural Central Hospital
Kasama-shi, Ibaraki, Japan
University Hospital Kyoto Prefectural Univ of Medicine
Kyoto, Kyoto, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
Tokushima Prefectural Central Hospital
Tokushima, Tokushima, Japan
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, Japan
Keio University Hospital
Tokyo, , Japan
Center for Hematologic Malignancy
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Cancer Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Yonsei University College of Medicine, Severance Hospital
Seoul, , South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Universitary Hospital La Princesa
Madrid, Salamanca, Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Countries
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Central Contacts
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References
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Lee HC, Zonder JA, Dhodapkar MV, Jagannath S, Hoffman JE, Suvannasankha A, Shah MR, Lentzsch S, Baz R, Maly JJ, Namburi S, Pianko MJ, Ye JC, Wu KL, Silbermann R, Min CK, Vekemans MC, Munder M, Byun JM, Martinez-Lopez J, DeVeaux M, Roccia T, Chokshi D, Seraphin M, Knorr K, Boyapati A, Hazra A, Rodriguez Lorenc K, Kroog GS, Bumma N, Richter J. Linvoseltamab in Patients With Relapsed/Refractory Multiple Myeloma in the LINKER-MM1 Study: Longer Follow-Up and Subgroup Analyses. Clin Lymphoma Myeloma Leuk. 2025 Nov 12:S2152-2650(25)04283-1. doi: 10.1016/j.clml.2025.11.004. Online ahead of print.
Bumma N, Richter J, Jagannath S, Lee HC, Hoffman JE, Suvannasankha A, Zonder JA, Shah MR, Lentzsch S, Baz R, Maly JJ, Namburi S, Pianko MJ, Ye JC, Wu KL, Silbermann R, Min CK, Vekemans MC, Munder M, Byun JM, Martinez-Lopez J, Cassady K, DeVeaux M, Chokshi D, Boyapati A, Hazra A, Yancopoulos GD, Sirulnik LA, Rodriguez Lorenc K, Kroog GS, Houvras Y, Dhodapkar MV. Linvoseltamab for Treatment of Relapsed/Refractory Multiple Myeloma. J Clin Oncol. 2024 Aug 1;42(22):2702-2712. doi: 10.1200/JCO.24.01008. Epub 2024 Jun 16.
Other Identifiers
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2024-511454-45-00
Identifier Type: CTIS
Identifier Source: secondary_id
R5458-ONC-1826
Identifier Type: -
Identifier Source: org_study_id