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Smoldering Multiple Myeloma

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Evaluation of initial safety and tolerability of the step-up regimen leading up to the start of full dose linvoseltamab.

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

Administration by intravenous (IV) infusion

Linvoseltamab

Clinical Trials Administrator

Clinical Trial Management

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)

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

Phase 2 Study of Linvoseltamab in Patients With Smoldering Multiple Myeloma at High Risk of Progression to Multiple Myeloma

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

AESI include grade 2 or higher cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)

As assessed by the NCI-CTCAE grading system version 5 (for all grades)

Regeneron Pharmaceuticals

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT05955508	Smoldering Mult...	Linvoseltamab	18 Years -	Regeneron Pharmaceuticals
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	NCT05955508	Smoldering Mult...	Linvoseltamab	18 Years -	Regeneron Pharmaceuticals

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