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Brief Title: A Study of Teclistamab in Japanese Participants With Relapsed or Refractory Multiple Myeloma
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
Study ID: NCT04696809
Brief 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.
Detailed Description:
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Kameda General Hospital, Chiba, , Japan
Ogaki Municipal Hospital, Gifu, , Japan
National Hospital Organization Mito Medical Center, Higashiibaraki-gun, , Japan
Kobe City Medical Center General Hospital, Hyogo, , Japan
National Hospital Organization Kumamoto Medical Center, Kumamoto-shi, , 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-City, , 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
Hiroshima West Medical Center, Otake, , Japan
Japanese Red Cross Medical Center, Shibuya, , Japan
Name: Janssen Pharmaceutical K.K., Japan Clinical trials
Affiliation: Janssen Pharmaceutical K.K.
Role: STUDY_DIRECTOR