A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Elranatamab — DRUG
  BCMA-CD3 bispecific antibody

Study Details

The purpose of the study (Part 1 and Part 2) is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and efficacy of different doses of elranatamab, as well as different intervals between doses. Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every week. The frequency of clinic visits for injections may then decrease over time. Participation will be at least two years.

Key Dates

Start date

Oct 7, 2021

Status verified

Jan 2026

Primary completion

Jun 15, 2023

Completion

Dec 12, 2025

Study Design

Enrollment

86 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1
  Evaluation of step-up priming dosing
• Experimental: Part 2A
  Dose determination
• Experimental: Part 2B
  Dose expansion
• Experimental: Part 2C
  To explore higher dose intensity

Primary Outcome Measure

Number of Participants With Grade 2 or Higher Cytokine Release Syndrome (CRS) During Cycle 1: Parts 1 and 2 [ Time Frame: Parts 1 and 2: Cycle 1 (28 days) ]

Locations (35)

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