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COMPLETED
NCT05228470
PHASE2

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

Sponsor: Pfizer

View on ClinicalTrials.gov

Summary

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.

Official title: A PHASE 1B/2, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF ELRANATAMAB (PF-06863135) IN CHINESE PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY (TRIPLE-CLASS REFRACTORY MM)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2021-12-21

Completion Date

2025-09-11

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

DRUG

Elranatamab

BCMA-CD3 bispecific antibody

Locations (15)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Shenzhen Second People's Hosptial

Shenzhen, Guangdong, China

Harbin First Hospital

Harbin, Heilongjiang, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

The First Hospital of Jilin University

Changchun, Jilin, China

Shandong Provincial Hospital

Jinan, Shandong, China

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Beijing Gaobo Boren Hospital

Beijing, China

Peking University Third Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

Hematology Hospital, Chinese Academy of Medical Sciences

Tianjin, China