In short
Clinical trials are studying Linvoseltamab in several blood-related diseases, mainly multiple myeloma and AL amyloidosis. These studies look at safety, how well the treatment works, and which patients may benefit most, including newly diagnosed, relapsed, refractory, transplant-eligible, and transplant-ineligible adults.
Key points
- Clinical trials of Linvoseltamab are being done mainly in multiple myeloma, including newly diagnosed, relapsed, and refractory cases. One study also includes relapsed or refractory systemic light chain amyloidosis, and another studies earlier plasma cell disorders that may lead to multiple myeloma. The trial phases range from Phase 1 to Phase 3, so the research includes early safety and dose finding as well as larger comparison studies. The main goals are to measure safety, response rates, complete response, minimal residual disease negativity, and progression-free survival. Some studies include transplant-eligible adults, while others focus on transplant-ineligible patients or people who have already received several prior treatments. Overall, the trials are testing Linvoseltamab alone and in combination with other treatments.
Clinical trial overview
These studies are testing Linvoseltamab in adults with blood cancers and related plasma cell disorders. The trials are all interventional, which means participants receive a study treatment and the research team measures the results.
The trial program includes Phase 1, Phase 2, and Phase 3 studies. Some trials are early studies that focus on safety and dose, while others compare Linvoseltamab with standard treatment or other active regimens.
Conditions being studied
Most trials study multiple myeloma, including newly diagnosed disease and disease that has returned or stopped responding to treatment.
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. 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.
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.
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.
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.
Who may take part
The studies mainly include adult participants.
- Newly diagnosed patients may join trials that study first-line treatment for multiple myeloma, including transplant-eligible and transplant-ineligible groups.
- Relapsed or refractory patients may join trials if their disease returned or did not respond after prior treatment.
- Transplant-eligible and transplant-ineligible patients are both included in some studies, showing that the program covers different treatment paths.
- 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.
Main endpoints being measured
The trials measure different endpoints, depending on the phase and patient group. An endpoint is the main result the study is designed to track.
- Safety endpoints include treatment-emergent adverse events, serious adverse events, and adverse events of special interest.
- Dose-limiting toxicities are used in early studies to help find a dose that can be given safely.
- Objective response rate measures how many participants have a meaningful reduction in disease.
- Complete response and very good partial response show how deeply the disease responds to treatment.
- Minimal residual disease negativity means very sensitive testing finds no detectable disease at the chosen level.
- Progression-free survival tracks how long participants live without the disease getting worse.
Trials that compare Linvoseltamab with other treatments
Several Phase 3 studies compare Linvoseltamab with standard treatment combinations or with another active regimen.
One study compares a Linvoseltamab-based approach after induction treatment with continued daratumumab, lenalidomide, and dexamethasone in newly diagnosed transplant-ineligible multiple myeloma. Another study compares Linvoseltamab monotherapy with the EPd combination, which includes elotuzumab, pomalidomide, and dexamethasone, in relapsed/refractory multiple myeloma.
A different Phase 3 study compares Linvoseltamab monotherapy and Linvoseltamab plus carfilzomib with standard-of-care regimens in relapsed/refractory multiple myeloma. These studies are designed to see whether Linvoseltamab can improve response and disease control compared with other available treatment options.
Key trial list
Below is a short list of the main studies included in this article.
- NCT06932562: Phase 3 study in newly diagnosed transplant-ineligible multiple myeloma, focused on MRD-negative complete response and progression-free survival.
- NCT03761108: Phase 1/2 study in relapsed or refractory multiple myeloma, focused on safety, dose finding, pharmacokinetics, and response.
- NCT05730036: Phase 3 study in relapsed/refractory multiple myeloma, comparing Linvoseltamab with EPd and measuring progression-free survival.
- NCT05828511: Phase 2 study in newly diagnosed multiple myeloma, including transplant-eligible and transplant-ineligible adults, with response and MRD endpoints.
- NCT06292780: Phase 1 study in relapsed or refractory AL amyloidosis, focused on safety and dose selection.
- NCT06140524: Phase 2 proof-of-concept study in high-risk MGUS and smoldering multiple myeloma, focused on safety and complete response.
- 2024-519504-27-00: Phase 3 study in relapsed/refractory multiple myeloma, comparing Linvoseltamab-based arms with standard therapy.
- 2025-522776-93-00: Phase 1 study in relapsed/refractory multiple myeloma, testing Linvoseltamab with REGN17372 for safety and early activity.