A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma
NCT ID: NCT05955508
Last Updated: 2025-09-04
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
PHASE2
40 participants
INTERVENTIONAL
2024-01-30
2032-12-19
Brief Summary
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The aim of the study is to understand the safety and tolerability (how your body reacts to linvoseltamab) as well as the effectiveness (how well linvoseltamab eliminates plasma cells and prevents the development of MM) of the study drug. There are 2 parts to the study.
* In Part 1, linvoseltamab will be given to a small number of participants to study the early side effects (safety) of the study drug and make sure the treatment is acceptable.
* In Part 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat HR-SMM and prevent progression to MM.
The study is looking at several other research questions, including:
* How many participants treated with linvoseltamab (study drug) have improvement of their HR-SMM?
* What side effects may happen from taking the study drug?
* How much study drug is in your blood at different times?
* Whether the body makes antibodies against the study drug (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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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Safety Run-In (Part 1)
Evaluation of initial safety and tolerability of the step-up regimen leading up to the start of full dose linvoseltamab.
Linvoseltamab
Administration by intravenous (IV) infusion
Expansion (Part 2)
Linvoseltamab monotherapy according to the same dosing schedule established in the safety run-in part.
Linvoseltamab
Administration by intravenous (IV) infusion
Interventions
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Linvoseltamab
Administration by intravenous (IV) infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
3. Adequate hematologic and hepatic function, as described in the protocol
4. Estimated glomerular filtration rate ≥30 mL/min/1.73 m\^2
Exclusion Criteria
\*SLiM (greater than or equal to Sixty percent clonal plasma cells in the bone marrow, involved/uninvolved free Light chain ratio of ≥100 with the involved free light chain (FLC) being ≥100 mg/L, MRI with \>1 focal lesion) CRAB (hyperCalcemia, Renal insufficiency, Anemia, or lytic Bone lesions)
2. Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), soft tissue plasmacytoma, or symptomatic multiple myeloma
3. Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol
4. Any infection requiring hospitalization or treatment with IV anti-infectives within 28 days of first dose of study drug
5. Uncontrolled human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection; or other uncontrolled infection or unexplained signs of infection
6. History of severe allergic reaction attributed to compounds with a similar chemical or biologic composition as the study drug or excipient
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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Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna, Spain
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain
Hospital Universitari Son Llatzer
Palma Mallorca, Balearic Islands, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Quiron Salud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Clinico Universitario Virgen De La Arrixaca
El Palmar, Murcia, Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, Navarre, Spain
University Hospital of Cabuenes
Gijón, Principality of Asturias, Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Institut Catala d'Oncologia
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon (HGUGM) - Instituto de Investigacion Sanitaria Gregorio Maranon
Madrid, , Spain
Clinica Universidad de Navarra - Madrid
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
University Hospital Doctor Peset
Valencia, , Spain
La Fe University Hospital
Valencia, , Spain
Countries
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Central Contacts
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Other Identifiers
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2023-503524-11-00
Identifier Type: OTHER
Identifier Source: secondary_id
R5458-ONC-2256
Identifier Type: -
Identifier Source: org_study_id
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