Table of Contents
- Clinical trial overview
- Conditions being studied
- Trial phases and main goals
- Who may take part
- Main endpoints being measured
- Trials that compare Linvoseltamab with other treatments
- Key trial list
Clinical trial overview
These studies are testing Linvoseltamab in adults with blood cancers and related plasma cell disorders.[1] The trials are all interventional, which means participants receive a study treatment and the research team measures the results.[1]
The trial program includes Phase 1, Phase 2, and Phase 3 studies.[1] Some trials are early studies that focus on safety and dose, while others compare Linvoseltamab with standard treatment or other active regimens.[1][3]
Conditions being studied
Most trials study multiple myeloma, including newly diagnosed disease and disease that has returned or stopped responding to treatment.[1][2][3]
One trial studies relapsed or refractory systemic light chain amyloidosis (also called AL amyloidosis), which is a disease where abnormal light chains build up and can harm organs.[5] Another trial studies high-risk monoclonal gammopathy of undetermined significance and non-high-risk smoldering multiple myeloma, which are earlier plasma cell disorders that may come before multiple myeloma.[6]
Trial phases and main goals
The Phase 1 studies mainly look at safety, tolerability, and dose-limiting toxicities, which are side effects serious enough to limit treatment.[2][5][7]
The Phase 2 studies look more closely at how well Linvoseltamab works, using measures such as objective response rate, very good partial response, complete response, and minimal residual disease status.[2][4][6]
The Phase 3 studies compare Linvoseltamab-based treatment with other treatment approaches in larger groups of patients, with outcomes such as progression-free survival and MRD-negative complete response.[1][3][7]
Who may take part
The studies mainly include adult participants.[2][4][5][6][7]
- Newly diagnosed patients may join trials that study first-line treatment for multiple myeloma, including transplant-eligible and transplant-ineligible groups.[1][4]
- Relapsed or refractory patients may join trials if their disease returned or did not respond after prior treatment.[2][3][5][7]
- Transplant-eligible and transplant-ineligible patients are both included in some studies, showing that the program covers different treatment paths.[1][4]
- Some studies also include people who previously received several lines of therapy, including those who are triple-refractory, meaning the disease no longer responds to three major drug classes.[2][3]
Main endpoints being measured
The trials measure different endpoints, depending on the phase and patient group.[1] An endpoint is the main result the study is designed to track.[1]
- Safety endpoints include treatment-emergent adverse events, serious adverse events, and adverse events of special interest.[2][4][7]
- Dose-limiting toxicities are used in early studies to help find a dose that can be given safely.[2][5][7]
- Objective response rate measures how many participants have a meaningful reduction in disease.[2][3]
- Complete response and very good partial response show how deeply the disease responds to treatment.[4][6][7]
- Minimal residual disease negativity means very sensitive testing finds no detectable disease at the chosen level.[1][4][7]
- Progression-free survival tracks how long participants live without the disease getting worse.[1][3]
Trials that compare Linvoseltamab with other treatments
Several Phase 3 studies compare Linvoseltamab with standard treatment combinations or with another active regimen.[1][3][7]
One study compares a Linvoseltamab-based approach after induction treatment with continued daratumumab, lenalidomide, and dexamethasone in newly diagnosed transplant-ineligible multiple myeloma.[1] Another study compares Linvoseltamab monotherapy with the EPd combination, which includes elotuzumab, pomalidomide, and dexamethasone, in relapsed/refractory multiple myeloma.[3]
A different Phase 3 study compares Linvoseltamab monotherapy and Linvoseltamab plus carfilzomib with standard-of-care regimens in relapsed/refractory multiple myeloma.[7] These studies are designed to see whether Linvoseltamab can improve response and disease control compared with other available treatment options.[1][3][7]
Key trial list
Below is a short list of the main studies included in this article.[1]
- NCT06932562: Phase 3 study in newly diagnosed transplant-ineligible multiple myeloma, focused on MRD-negative complete response and progression-free survival.[1]
- NCT03761108: Phase 1/2 study in relapsed or refractory multiple myeloma, focused on safety, dose finding, pharmacokinetics, and response.[2]
- NCT05730036: Phase 3 study in relapsed/refractory multiple myeloma, comparing Linvoseltamab with EPd and measuring progression-free survival.[3]
- NCT05828511: Phase 2 study in newly diagnosed multiple myeloma, including transplant-eligible and transplant-ineligible adults, with response and MRD endpoints.[4]
- NCT06292780: Phase 1 study in relapsed or refractory AL amyloidosis, focused on safety and dose selection.[5]
- NCT06140524: Phase 2 proof-of-concept study in high-risk MGUS and smoldering multiple myeloma, focused on safety and complete response.[6]
- 2024-519504-27-00: Phase 3 study in relapsed/refractory multiple myeloma, comparing Linvoseltamab-based arms with standard therapy.[7]
- 2025-522776-93-00: Phase 1 study in relapsed/refractory multiple myeloma, testing Linvoseltamab with REGN17372 for safety and early activity.[8]
