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Study details
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A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment

Regeneron Pharmaceuticals
NCT IDNCT05828511ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1/2

Target enrollment

132

Study length

about 12 years

Ages

18+

Locations

13 sites in CA, CO, KY +5

About this study

Researchers are testing a new drug called linvoseltamab in adults with recently diagnosed multiple myeloma who are not yet treated. The goal of this clinical trial is to determine if the drug is safe, well-tolerated, and effective at shrinking tumors in these patients. It will involve two phases: Phase 1 to assess safety and dosage, and Phase 2 to evaluate tumor shrinkage.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Linvoseltamab
PhasePhase 1/Phase 2
DrugLinvoseltamab
Primary goalIncidence of Adverse Events of Special Interest (AESIs)

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low7%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Endpoints

Primary: Incidence of Adverse Events of Special Interest (AESIs), Incidence of Dose-Limiting Toxicities (DLTs), Incidence of Treatment-Emergent Adverse Events (TEAEs), Severity of TEAEs

Secondary: DOR by risk levels, DOR of participants deemed transplant-eligible and transplant-ineligible by the treating physician, Duration Of Response (DOR) measured using the IMWG criteria, Incidence of TEAEs, ORR by risk levels, ORR of participants deemed transplant-eligible and transplant-ineligible by the treating physician, Objective Response Rate (ORR) measured using the IMWG criteria, Overall Survival (OS) of participants deemed transplant-eligible and transplant-ineligible by the treating physician

Body systems

Oncology