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ACTIVE NOT RECRUITING
NCT04696809
PHASE1/PHASE2

A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Sponsor: Janssen Pharmaceutical K.K.

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the safety and tolerability in Japanese participants with relapsed or refractory multiple myeloma (RRMM) at the recommended Phase 2 dose (RP2D) identified in Study 64007957MMY1001 (NCT03145181) in Phase 1 part and to evaluate the efficacy of teclistamab at RP2D for Japanese participants in Phase 2 part.

Official title: A Phase 1/2 Study of JNJ-64007957, a Humanized BCMA * CD3 Bispecific Antibody in Japanese Patients With Relapsed or Refractory Multiple Myeloma

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2021-02-22

Completion Date

2026-04-22

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DRUG

Teclistamab

Teclistamab will be administered subcutaneously.

Locations (15)

Kameda Medical Center

Chiba, Japan

Ogaki Municipal Hospital

Gifu, Japan

National Hospital Organization Mito Medical Center

Higashiibaraki-gun, Japan

Kobe City Medical Center General Hospital

Kobe, Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, Japan

Kurume University Hospital

Kurume, Japan

Kyoto Kuramaguchi Medical Center

Kyoto, Japan

National Hospital Organization Matsumoto Medical Center

Matsumoto, Japan

Nagoya City University Hospital

Nagoya, Japan

Niigata Cancer Center Hospital

Niigata, Japan

National Hospital Organization Okayama Medical Center

Okayama, Japan

Osaka International Cancer Institute

Osaka, Japan

Japanese Red Cross Osaka Hospital

Osaka, Japan

National Hospital Organization Hiroshima-Nishi Medical Center

Ōtake, Japan

Japanese Red Cross Medical Center

Shibuya City, Japan