Phase 2 Dose-Ranging and Interception Study of Linvoseltamab in Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The primary purpose of the study is to understand how well the study drug can eliminate abnormal plasma cells and laboratory signs of high-risk monoclonal gammopathy of undetermined significance (HR-MGUS) and non high-risk smoldering multiple myeloma (NHR-SMM). This requires understanding the safety and tolerability of the study drug (how the body reacts to linvoseltamab) as well as the effectiveness of the study drug (how well linvoseltamab eliminates plasma cells). All participants will start treatment with gradually increasing doses of linvoseltamab (step-up doses) before they start receiving the assigned full dose. The study is split into 2 parts: * In Part 1, separate groups of 3-6 patients will receive different full doses of linvoseltamab to evaluate the short-term side effects (safety) and tolerability of the study drug within the first 5 weeks after starting treatment. The data collected will help to make a decision about the dosing regimens chosen for Part 2. * In Part 2, a larger number of participants will be randomized to different dosing regimens to further assess the side effects of linvoseltamab, and to evaluate the ability of linvoseltamab to eliminate abnormal plasma cells in 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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• HR-MGUS or NHR-SMM as defined in the protocol

• Eastern Cooperative Oncology Group (ECOG) performance status ≤1

• Adequate hematologic and hepatic function, as described in the protocol

• Estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73 m2 by the modification of diet in renal disease (MDRD) equation

Locations
United States
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
New York
Stony Brook University Hospital
RECRUITING
Stony Brook
Other Locations
Spain
Hospital Sant Pau
RECRUITING
Barcelona
Hospital Clinico Universitario Virgen De La Arrixaca
RECRUITING
El Palmar
Hospital de Cabuenes
RECRUITING
Gijon
Hospital Universitario Virgen de las Nieves
RECRUITING
Granada
Hospital General Universitario Morales Meseguer
RECRUITING
Murcia
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2024-09-16
Estimated Completion Date: 2032-05-18
Participants
Target number of participants: 104
Treatments
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
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov