drugset / Trial / NCT05137054

A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

NCT05137054 ↗

Phase 1 Recruiting 317 enrolled Regeneron Pharmaceuticals
Non-randomizedSequentialOpen-labelTreatment

Summary

This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again. In the initial study, some participants treated with linvoseltamab had improvement of their myeloma, including complete responses (no evidence of myeloma in their bodies). This study is the first time linvoseltamab will be combined with other cancer therapies. The main goal is to understand if linvoseltamab can be given safely with other cancer treatments, and if so, what dose of linvoseltamab should be used for each combination. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab in combination with each of the other cancer treatments have improvement of their multiple myeloma * What side effects may happen from taking linvoseltamab together with another cancer treatment * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)

Timeline

Start
2022-08-17
Primary completion
2028-03-25
Completion
2032-03-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule — —
Subject Carfilzomib Other / unclassified — —
Subject Cemiplimab Monoclonal antibody — —
Subject Cevostamab Monoclonal antibody — —
Subject Daratumumab Monoclonal antibody — —
Subject Fianlimab Monoclonal antibody — —
Subject Isatuximab Monoclonal antibody — —
Subject Lenalidomide Other / unclassified — —
Subject Linvoseltamab Monoclonal antibody — —
Subject Nirogacestat Small molecule — —
Subject Pomalidomide Other / unclassified — —

Indications