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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06140524
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Monoclonal Gammopathy of Undetermined Significance (MGUS)
  • Smoldering Multiple Myeloma (SMM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Sep 16, 2024
Status verified
May 2026
Primary completion
May 18, 2032
Completion
May 18, 2032

Study Design

Enrollment
116 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Run-In (Part 1)
    Sequential groups of participants will be enrolled to assess the initial safety and tolerability of the step-up regimen leading up to the start of different full doses of linvoseltamab.
  • Experimental: Expansion (Part 2) - Dose regimen 1
    Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens
  • Experimental: Expansion (Part 2) - Dose regimen 2
    Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens
  • Experimental: Expansion (Part 2) - Dose regimen 3
    Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens
  • Experimental: Expansion (Part 2) - Dose regimen 4
    Participants will be randomized in a 1:1:1:1 ratio across 4 dosing regimens

Primary Outcome Measure

Frequency of Adverse Events Interest (AEI) during the safety observation period [ Time Frame: 35 days ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
University of Michigan HealthAnn ArborMichigan48109-
NYU Langone Health Perlmutter Cancer CenterNew YorkNew York10016-
Stony Brook University HospitalStony BrookNew York11794-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
University of WashingtonSeattleWashington98109-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins Hospital· Baltimore, MDDana-Farber Cancer Institute· Boston, MAUniversity of Michigan Health· Ann Arbor, MINYU Langone Health Perlmutter Cancer Center· New York, NYStony Brook University Hospital· Stony Brook, NYThomas Jefferson University Hospital· Philadelphia, PA

Related Studies