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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 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. The trial reports 13 study locations across 11 states.

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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).

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

FieldValue
Enrollment Target 116 participants
Start Date 2024-09-16
Est. Completion 2032-05-18
Phase Phase 2

Sponsor

Regeneron Pharmaceuticals

280 total trials

What the Registry Record Tells You About NCT06140524

The ClinicalTrials.gov registry entry for NCT06140524 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.

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 reports 13 study locations spanning 11 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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