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NCT05137054 · ClinicalTrials.gov registry record · Phase 1

A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

A Phase 1 study of Multiple Myeloma, sponsored by Regeneron Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
317
Enrollment target
20
Study locations

NCT05137054: Recruiting Phase 1 study of Multiple Myeloma, sponsored by Regeneron Pharmaceuticals.

NCT05137054 is a Phase 1 study of Multiple Myeloma that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 317 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05137054, a Phase 1 study of Multiple Myeloma, is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
317 participants
Enrollment target
20
Study locations

Study Summary

This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again. In the initial study, some participants treated with linvoseltamab had improvement of their myeloma, including complete responses (no evidence of myeloma in their bodies). This study is the first time linvoseltamab will be combined with other cancer therapies. The main goal is to understand if linvoseltamab can be given safely with other cancer treatments, and if so, what dose of linvoseltamab should be used for each combination. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab in combination with each of the other cancer treatments have improvement of their multiple myeloma * What side effects may happen from taking linvoseltamab together with another cancer treatment * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)

Primary Outcome

Dose finding portion only

Conditions Studied

Interventions

  • DRUG Lenalidomide
  • DRUG Daratumumab
  • DRUG Carfilzomib
  • DRUG Linvoseltamab
  • DRUG Bortezomib

Study Locations (20)

Other

  • Centre Hospitalier Universitaire Angers - Angers
  • CHU Montpellier - Departement D'Hematologie - Montpellier
  • Saint Antoine Hospital - Paris
  • Institut Gustave Roussy - Villejuif

New York

  • Weill Cornell Medicine/New York Presbyterian Hospital - New York
  • New York Presbyterian Hospital Columbia University Medical Center - New York

North Carolina

  • University of North Carolina at Chapel Hill - Chapel Hill
  • Wake Forest University Health Sciences - Winston-Salem

California

  • Scripps Clinic Torrey Pines - La Jolla

Georgia

  • Winship Cancer Institute of Emory University - Atlanta

Indiana

  • Indiana University Health Simon Cancer Center - Indianapolis

Massachusetts

  • Dana Farber/Harvard Cancer Center - Boston

Michigan

  • Karmanos Cancer Institute - Detroit

Trial Details

FieldValue
Enrollment Target 317 participants
Start Date 2022-08-17
Est. Completion 2034-09-26
Phase Phase 1
Regeneron Pharmaceuticals

280 total trials

What NCT05137054 shows while recruiting

NCT05137054 is an interventional study that assigns participants to a tested intervention. The registered 317 participants enrollment target is mid-sized for trials with a published cap, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (42% lower).

The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Lenalidomide is the first listed.

NCT05137054 names 20 study sites across 15 states, led by Other, New York, North Carolina.

Frequently Asked Questions

What is clinical trial NCT05137054 about?

NCT05137054 is a clinical study titled "A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments". This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that re...

What is the current status of trial NCT05137054?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 317 participants. The study started on 2022-08-17. Estimated completion is 2034-09-26.

What conditions does trial NCT05137054 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT05137054?

The interventions under investigation include: Lenalidomide (DRUG), Daratumumab (DRUG), Carfilzomib (DRUG), Linvoseltamab (DRUG), Bortezomib (DRUG).

Who is sponsoring clinical trial NCT05137054?

This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05137054 being conducted?

This trial has 20 study locations across California, Georgia, Indiana, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Multiple Myeloma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05137054's enrollment target sits among peer trials

317 69th of 438 higher than 370 of 438 other Multiple Myeloma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05137054, the US trial registry maintained by the National Library of Medicine. NCT05137054 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.