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
NCT ID: NCT05828511
Last Updated: 2025-12-03
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
132 participants
INTERVENTIONAL
2023-12-19
2035-11-02
Brief Summary
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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, 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 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 ability 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).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1 cohort
Linvoseltamab dose escalation (part A) and dose expansion (part B) for participants with NDMM who are treatment-naïve.
Linvoseltamab
Linvoseltamab will be administered by intravenous (IV) infusion
Phase 2 - transplant ineligible cohort
Transplant-ineligible participants, enrolled in dose expansion, will receive selected Linvoseltamab regimen until disease progression as per protocol.
Linvoseltamab
Linvoseltamab will be administered by intravenous (IV) infusion
Phase 2 - transplant eligible cohort
Transplant-eligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen for a fixed duration of treatment as per protocol
Linvoseltamab
Linvoseltamab will be administered by intravenous (IV) infusion
Interventions
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Linvoseltamab
Linvoseltamab will be administered by intravenous (IV) infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Confirmed diagnosis of symptomatic multiple myeloma (MM) by International Myeloma Working Group (IMWG) diagnosis criteria
3. Measurable disease, according to the 2016 IMWG response criteria, as defined in the protocol
4. No prior therapy for MM, with the exception of prior emergent or palliative radiation and up to 1 month of single-agent corticosteroids, with washout periods as per the protocol
5. Participants must have evidence of adequate bone marrow reserves and hepatic, renal and cardiac function as defined in the protocol
6. Participants must be age \<70 and have adequate hepatic, renal, pulmonary and cardiac function to be considered transplant-eligible. The specific thresholds for adequate organ function are as per institutional guidance.
Exclusion Criteria
2. Known central nervous system (CNS) involvement with MM, known or suspected progressive multifocal leukoencephalopathy (PML), a history of neurocognitive conditions, or CNS movement disorder, or history of seizure within 12 months prior to study enrollment
3. Rapidly progressive symptomatic disease, (e.g. progressing renal failure or hypercalcemia not responsive to standard medical interventions), in urgent need of treatment with chemotherapy
4. Diagnosis of non-secretory MM, active plasma cell leukemia, primary light-chain (AL) amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or known POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
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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University of California Los Angeles (UCLA)
Los Angeles, California, United States
UC Irvine Health
Orange, California, United States
Colorado Blood Cancer Institute/SCRI
Denver, Colorado, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Perlmutter Cancer Center
New York, New York, United States
Columbia University _ New York Presbyterian
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Health System (DUHS)
Durham, North Carolina, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, Nouvelle-Aquitaine, France
CHU De Lille
Lille, , France
Centre Hospitalier Universitaire (CHU) Montpellier
Montpellier, , France
Hopital Saint Louis
Paris, , France
Hopital Pitié Salpetriere APHP
Paris, , France
Hopital Prive d'Antony
Antony, Île-de-France Region, France
Hopital Necker
Paris, Île-de-France Region, France
Gustave Roussy
Villejuif, Île-de-France Region, France
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario Quiron Salud Madrid
Pozuelo de Alarcón, Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital General Universitario Doctor Balmis Alicante
Alicante, Valencia, Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Institut Catala dOncologia (ICO Hospitalet)
Barcelona, , Spain
Universitary Hospital La Princesa
Madrid, , Spain
Clinica Universidad de Navarra - Madrid
Madrid, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
La Fe University Hospital
Valencia, , Spain
Countries
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Central Contacts
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Other Identifiers
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2022-500800-24-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
R5458-ONC-2158
Identifier Type: -
Identifier Source: org_study_id
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