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Study details
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Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma

Regeneron Pharmaceuticals
NCT IDNCT03761108ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1/2

Target enrollment

387

Study length

about 14 years

Ages

18+

Locations

14 sites in FL, GA, IN +8

What this study is about

Researchers are testing the safety and best dose of linvoseltamab, a medication, for adults with relapsed or refractory multiple myeloma. The trial also investigates potential side effects, how linvoseltamab works, and its effectiveness in treating cancer.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Linvoseltamab

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Standard

How treatment is administered

Treatment Assignment
All receive treatment

Everyone gets the investigational treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Endpoints

Primary: Assessment of the pharmacokinetics (PK) of linvoseltamab, Incidence and severity of adverse events of special interest (AESI), Incidence and severity of cytokine release syndrome (CRS) with linvoseltamab, Incidence and severity of treatment-emergent adverse events (TEAEs), Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period, ORR of IV linvoseltamab as assessed by investigator, Objective response rate (ORR) as determined by an Independent Review Committee (IRC)

Secondary: Change in patient-reported global health status/QoL per EORTC QLQ-C30, DOR as determined by an investigator, measured using the International Myeloma Working Group (IMWG) criteria, Duration of response (DOR) as determined by an IRC, measured using the IMWG criteria, Effects of linvoseltamab on HRQOL and patient-reported symptoms and functioning per EuroQoL-5 Dimension-3 Level Scale [EQ-5D-3L]), Effects of linvoseltamab on HRQOL and patient-reported symptoms and functioning per Quality of Life Questionnaire-Multiple Myeloma module 20 [QLQ-MY20]), Effects of linvoseltamab on general health status per EQ-5D-3L, Effects of linvoseltamab on health-related quality of life (HRQoL) and patient-reported symptoms and functioning per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Effects of linvoseltamab on patient-reported functions and symptoms per EORTC QLQ-C30

Body systems

Oncology