NCT05955508

A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Adult Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma

Active, enrolled Phase 2 Last updated 13 April 2026

What this trial tests

Phase 2 trial testing Linvoseltamab in Smoldering Multiple Myeloma (SMM) in 40 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

30 January 2024

Primary endpoint
25 January 2033

25 January 2033

Quick facts

Lead sponsor	Regeneron Pharmaceuticals
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	30 January 2024
Primary completion	25 January 2033
Estimated completion	25 January 2033
Sites	17 locations across Spain

Drugs / interventions tested

• Linvoseltamab (LINVOSELTAMAB) — full drug profile →

Conditions studied

• Smoldering Multiple Myeloma (SMM) — all drugs for Smoldering Multiple Myeloma (SMM) →

Sponsor

Regeneron Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Smoldering Multiple Myeloma (SMM). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 the 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 further 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 the blood at different times?
* Whether the body makes antibodies against the study drug (which could make linvoseltamab less effective or could lead to side effects)

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bispecific antibodies in the treatment of multiple myeloma.
   Devasia AJ, Chari A, Lancman G. · · 2024 · cited 37× · PMID 39266530 · DOI 10.1038/s41408-024-01139-y
2. Multiple Myeloma: The Role of Autologous Stem Cell Transplantation in the Era of Immunotherapy.
   Rocchi S, Zannetti BA, Marconi G, Lanza F. · · 2024 · cited 11× · PMID 38786075 · DOI 10.3390/cells13100853
3. Bispecific antibodies for the treatment of relapsed/refractory multiple myeloma: updates and future perspectives.
   Parrondo RD, Ailawadhi S, Cerchione C. · · 2024 · cited 10× · PMID 38660139 · DOI 10.3389/fonc.2024.1394048
4. Bispecific Antibodies in Hematologic Malignancies: Attacking the Frontline.
   Shastri T, Trabolsi A, Arumov A, Schatz JH. · · 2025 · cited 4× · PMID 40751114 · DOI 10.1007/s40259-025-00735-z
5. Smoldering multiple myeloma: Integrating biology and risk into management.
   Patel R, Hill E, Dhodapkar M. · · 2025 · cited 2× · PMID 39603907 · DOI 10.1053/j.seminhematol.2024.10.002
6. Navigating the evolving management of smoldering multiple myeloma.
   Hammami MB, Canevarolo RR, Silva AS, Alsina M, et al · · 2026 · PMID 41523082 · DOI 10.1002/hem3.70275