Linvoseltamab for Multiple Myeloma
(LINKER-MGUS1 Trial)
Trial Summary
What is the purpose of this trial?
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).
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Linvoseltamab for treating multiple myeloma?
Monoclonal antibodies, like Linvoseltamab, have shown promise in treating multiple myeloma by targeting specific proteins on cancer cells, leading to their destruction. Similar treatments, such as daratumumab and isatuximab, have improved patient outcomes by being incorporated into standard treatment regimens, suggesting potential effectiveness for Linvoseltamab as well.12345
What is known about the safety of Linvoseltamab (REGN-5458) for multiple myeloma?
How is the drug Linvoseltamab different from other treatments for multiple myeloma?
Linvoseltamab is unique because it is a bispecific antibody that targets both BCMA (B-cell maturation antigen) on myeloma cells and CD3 on T-cells, helping the immune system directly attack the cancer cells. This dual-targeting approach is different from other treatments that typically focus on a single target.2341112
Research Team
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Eligibility Criteria
Adults with high-risk monoclonal gammopathy (HR-MGUS) or non-high-risk smoldering multiple myeloma (NHR-SMM) can join this study. They should be relatively healthy, able to perform daily activities with ease (ECOG ≤1), and have good blood and liver function. Their kidneys must also work well enough to filter waste from the blood.Inclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
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.
Expansion (Part 2)
Participants will be randomized to different dosing regimens to further assess the side effects of linvoseltamab and evaluate its ability to eliminate abnormal plasma cells.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Linvoseltamab (Monoclonal Antibodies)
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Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor