A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma.

Sponsor
Pfizer
Study ID
NCT05228470
Phase
PHASE2
Status
Completed

Conditions

  • BCMA
  • BCMA-CD3 Bispecific
  • Bispecific
  • Bispecific Antibody
  • Elranatamab
  • MagnetisMM-8
  • Multiple Myeloma
  • Myeloma
  • PF-06863135
  • Refractory Multiple Myeloma
  • Relapsed Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to understand the study medicine (called Elranatamab, or PF-06863135) as potential treatment for refractory multiple myeloma. Multiple myeloma is a form of cancer in the bone that forces healthy blood cells to go out. Sometimes, multiple myeloma does not respond to current therapy or quickly progresses, and this is called refractory multiple myeloma. Elranatamab is a study medicine that target multiple myeloma and activates the human body to fight against this disease. We are seeking Chinese participants to take part in this study. The study will be 2 parts, called part 1b and part 2. In part 1b, participants will receive Elranatamab at 2 steps priming and full dose as a sc (subcutaneous injection) therapy. We will monitor participants' safety and reactions to the study medicine. This will help us understand the dosage of Elranatamab to be used safely. In part 2 of the study, participants will receive Elranatamab and their multiple myeloma growth will be monitored. This will help us understand if Elranatamab, when used alone, may be a therapy for refractory multiple myeloma. Participants in this part of the study are expected to take part for about 2 years.

Key Dates

Start date
Dec 21, 2021
Status verified
Dec 2025
Primary completion
Aug 6, 2023
Completion
Sep 11, 2025

Study Design

Enrollment
39 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Elranatamab
    BCMA-CD3 bispecific antibody

Primary Outcome Measure

Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT) [ Time Frame: Cycle 1 (28 days) ]

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