NCT05137054

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

Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 317 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Linvoseltamab	Linvoseltamab is administered by intravenous (IV) infusion
DRUG	Daratumumab	Daratumumab is administered by IV infusion and/or subcutaneous (SC) injection; SC injection may be used after a minimum of 2 cycles of IV administration at the investigator's discretion.
DRUG	Carfilzomib	Carfilzomib is administered by IV infusion
DRUG	Lenalidomide	Lenalidomide is administered by mouth (PO) as a capsule
DRUG	Bortezomib	Bortezomib is administered by IV infusion or SC injection
DRUG	Pomalidomide	Pomalidomide is administered by mouth (PO) as a capsule
DRUG	Isatuximab	Isatuximab is administered by IV infusion
DRUG	Fianlimab	Fianlimab is administered by IV infusion
DRUG	Cemiplimab	Cemiplimab is administered by IV infusion
DRUG	Nirogacestat	Nirogacestat is administered by mouth (PO) as a tablet
DRUG	Cevostamab	Cevostamab is administered by IV infusion

Timeline

• Start date: 2022-08-17
• Primary completion: 2028-04-11
• Completion: 2034-09-26
• First posted: 2021-11-30
• Last updated: 2026-01-22

Locations

42 sites across 5 countries: United States, France, Greece, Israel, Spain

Regulatory

• FDA-regulated drug study