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NCT06140524 · ClinicalTrials.gov registry record · Phase 2
A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma
A Phase 2 study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM), sponsored by Regeneron Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 116
- Enrollment target
- 13
- Study locations
NCT06140524: Recruiting Phase 2 study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM), sponsored by Regeneron Pharmaceuticals.
NCT06140524 is a Phase 2 study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM) that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 116 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06140524, a Phase 2 study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM), is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 116 participants
- Enrollment target
- 13
- Study locations
Study Summary
This study is researching an investigational drug called linvoseltamab ("study drug") in participants at moderate risk of developing multiple myeloma (about 3 to 10% average annual risk), a group that consists of patients with precancerous conditions called High-Risk Monoclonal Gammopathy of Undetermined Significance (HR-MGUS) and Non-High-Risk Smoldering Multiple Myeloma (NHR-SMM). The primary purpose of the study is to understand how well the study drug can eliminate abnormal plasma cells and laboratory signs of HR-MGUS and NHR-SMM. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab have improvement of their HR-MGUS or NHR-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 the drug less effective or could lead to side effects).
Primary Outcome
Part 1 An AEI is a toxicity potentially related to study treatment that may preclude dose escalation or expansion according to the Bayesian Optimal Interval (BOIN) design decision rules
Conditions Studied
Interventions
- DRUG Linvoseltamab
Study Locations (13)
Other
- Hospital Sant Pau - Barcelona
- Universitaru Hospital La Princesa - Madrid
- Hospital General Universitario Morales Meseguer - Murcia
Maryland
- Johns Hopkins Hospital - Baltimore
Massachusetts
- Dana-Farber Cancer Institute - Boston
Michigan
- University of Michigan Health - Ann Arbor
New York
- Stony Brook University Hospital - Stony Brook
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
Washington
- University of Washington - Seattle
Andalusia
- Hospital Universitario Virgen de las Nieves - Granada
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2024-09-16 |
| Est. Completion | 2032-05-18 |
| Phase | Phase 2 |
What NCT06140524 shows while recruiting
NCT06140524 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower).
The record links to 2 conditions, with Monoclonal Gammopathy of Undetermined Significance (MGUS) appearing as the primary indexed condition, and to 1 intervention - of which Linvoseltamab is the first listed.
NCT06140524 lists 13 locations in 11 states (Other, Maryland, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT06140524 about?
NCT06140524 is a clinical study titled "A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma". This study is researching an investigational drug called linvoseltamab ("study drug") in participants at moderate risk of developing multiple myeloma (about 3 to 10% average annual risk), a group that consists of patients with precancerous conditions called High-Risk Monoclonal Gammopathy of Undeter...
What is the current status of trial NCT06140524?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2024-09-16. Estimated completion is 2032-05-18.
What conditions does trial NCT06140524 study?
This clinical trial studies the following conditions: Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM).
What interventions are being tested in trial NCT06140524?
The interventions under investigation include: Linvoseltamab (DRUG).
Who is sponsoring clinical trial NCT06140524?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06140524 being conducted?
This trial has 13 study locations across Maryland, Massachusetts, Michigan, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT06140524's enrollment target sits among peer trials
116 623rd of 2000 higher than 1,375 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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