220
Participants
Start Date
November 23, 2017
Primary Completion Date
July 2, 2020
Study Completion Date
March 8, 2024
Velcade
Participants will receive velcade 1.3 mg/m\^2, SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9 of Treatment Arm A and B.
Melphalan
Participants will receive melphalan 9 mg/m\^2 (if serum creatine is \>2 mg/dL at baseline, participants must be administrated 4.5 mg/m\^2 of melphalan, instead of 9 mg/m\^2), orally, once daily on Days 1 to 4 of each cycle up to Cycle 9 Treatment Arm A and B.
Prednisone
Participants will receive prednisone 60 mg/m\^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9 Treatment Arm A and B.
Daratumumab
Participants will receive daratumumab 16 mg/kg as IV infusion or daratumumab SC, once weekly, for 6 weeks in Cycle 1 and then once every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or the end of study in Treatment Arm B.
National Taiwan University Hospital, Taipei
Hospital Pulau Pinang, George Town
Taipei Veterans General Hospital, Taipei
Seoul National University Bundang Hospital, Seongnam-si
Chang Gung Memorial Hospital, Taoyuan District
Ulsan University Hospital, Ulsan
Inje University Busan Paik Hospital, Busan
Chonnam National University Hwasun Hospital, Jeollanam-do
Hospital Ampang, Ampang
Hospital Queen Elizabeth, Kota Kinabalu
Beijing Chaoyang Hospital, Beijing
Peking Union Medical College Hospital, Beijing
Peking University First Hospital, Beijing
Beijing Chaoyang Hospital, Beijing
Peking University Third Hospital, Beijing
The First Hospital of Jilin University, Changchun
Harbin medical university cancer hospital, Harbin
Shanghai Changzheng Hospital, Shanghai
Ruijin Hospital, Shanghai Jiao Tong University, Shanghai
Shanghai Zhongshan Hospital, Shanghai
Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai
Nanjing Drum Tower Hospital, Nanjing
Zhongda Hospital Southeast University, Nanjing
Jiangsu Province Hospital, Nanjing
First Affiliated Hospital SooChow University, Suzhou
Tianjin cancer hospital, Tianjin
Institute of Hematology and Blood Diseases Hospital, Tianjin
First Affiliated Hospital Medical School of Zhejiang University, Hangzhou
First affiliated Hospital of Zhejiang University, Hangzhou
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou
Fujian Meidical University Union Hospital, Fuzhou
Second Affiliated Hospital of Army Medical University, Chongqing
The Third Xiangya Hospital, Central South University, Changsha
Tongji Hospital, Tongji Medical College of HUST, Wuhan
Henan Cancer Hospital, Zhengzhou
Guangdong Provincial People's Hospital, Guangzhou
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou
Nanfang Hospital, Guangzhou
West China Hospital Si Chuan University, Chengdu
Tangdu Hospital, Xi'an
Queen Mary Hospital University of Hong Kong, Hong Kong
Gachon University Gil Medical Center, Incheon
Samsung Medical Center, Seoul
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul
Janssen Research & Development, LLC
INDUSTRY