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

Study Purpose

This study is researching an investigational drug called linvoseltamab ("study drug") in participants at high risk of developing multiple myeloma (MM), a group commonly labeled as high-risk smoldering multiple myeloma (HR-SMM). 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)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

KEY

Inclusion Criteria:

1. High-risk SMM diagnosis within 5 years of study enrollment. 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. KEY

Exclusion Criteria:

1. Evidence of myeloma defining events *SLiM CRAB, as described in the protocol. *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. NOTE: Other protocol defined inclusion/exclusion criteria apply

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05955508
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Regeneron Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Trial Management
Principal Investigator Affiliation	Regeneron Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Smoldering Multiple Myeloma (SMM)

Arms & Interventions

Arms

Experimental: 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.

Experimental: Expansion (Part 2)

Linvoseltamab monotherapy according to the same dosing schedule established in the safety run-in part.

Interventions

Drug: - Linvoseltamab

Administration by intravenous (IV) infusion

Contact a Trial Team

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