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A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma
Sponsor: Janssen Pharmaceutical K.K.
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
Conditions
Interventions
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