Phase
Condition
Multiple Myeloma
Red Blood Cell Disorders
Cancer
Treatment
Daratumumab
Melphalan
Prednisone
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Documented multiple myeloma satisfying the calcium elevation, renal insufficiency,anemia, and bone abnormalities (CRAB) diagnostic criteria, monoclonal plasma cells inthe bone marrow greater than or equal to (>=) 10 percent (%) or presence of a biopsyproven plasmacytomas, and measurable secretory disease, as assessed by the centrallaboratory, and defined in protocol
- Newly diagnosed and not considered candidate for high-dose chemotherapy with stem celltransplantation (SCT) due to: being age >= 65 years, or in participants less than (<) 65 years: presence of important comorbid conditions likely to have a negative impacton tolerability of high dose chemotherapy with stem cell transplantation
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Meet the clinical laboratory criteria as specified in the protocol
- A woman of childbearing potential must have a negative serum or urine pregnancy testsat screening within 14 days prior to randomization
Exclusion
Exclusion Criteria:
- Primary amyloidosis, monoclonal gammopathy of undetermined significance, or smolderingmultiple myeloma
- Waldenstrom's disease, or other conditions in which Immunoglobulin M (IgM) M-proteinis present in the absence of a clonal plasma cell infiltration with lytic bone lesions
- Prior or current systemic therapy or SCT for multiple myeloma, with the exception ofan emergency use of a short course (equivalent of dexamethasone 40 milligram per day (mg/day) for 4 days) of corticosteroids before treatment
- Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by thenational cancer institute common terminology criteria for adverse events (NCI-CTCAE),Version 4.03
- History of malignancy (other than multiple myeloma) within 3 years before the date ofrandomization (exceptions are squamous and basal cell carcinomas of the skin andcarcinoma in situ of the cervix, or malignancy that in the opinion of theinvestigator, with concurrence with the sponsor's medical monitor, is considered curedwith minimal risk of recurrence within 3 years)
- Radiation therapy within 14 days of randomization
- Seropositive for hepatitis B (defined by a positive test for hepatitis B surfaceantigen [HBsAg]). Participants with resolved infection (that is, participants who areHBsAg negative but positive for antibodies to hepatitis B core antigen [Anti-HBc]and/or antibodies to hepatitis B surface antigen [Anti-HBs]) must be screened usingreal-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV)deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded.EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (Anti-HBs positivity as the only serologic marker) AND a known history of prior HBVvaccination, do not need to be tested for HBV DNA by PCR
Study Design
Connect with a study center
Beijing Chaoyang Hospital
Beijing, 100020
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing, 100032
ChinaSite Not Available
Peking University First Hospital
Beijing, 100034
ChinaSite Not Available
Peking University Third Hospital
Beijing, 100083
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, 130021
ChinaSite Not Available
The Third Xiangya Hospital, Central South University
Changsha, 410013
ChinaSite Not Available
West China Hospital Si Chuan University
Chengdu, 610041
ChinaSite Not Available
West China Hospital, Si Chuan University
Chengdu, 610041
ChinaSite Not Available
Second Affiliated Hospital of Army Medical University
Chongqing, 400037
ChinaSite Not Available
Fujian Meidical University Union Hospital
Fuzhou, 350001
ChinaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou, 510080
ChinaSite Not Available
Nanfang Hospital
Guangzhou, 510515
ChinaSite Not Available
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, 510080
ChinaSite Not Available
First Affiliated Hospital Medical School of Zhejiang University
Hangzhou, 310020
ChinaSite Not Available
First Affiliated Hospital, Medical School of Zhejiang University
Hangzhou, 310020
ChinaSite Not Available
First affiliated Hospital of Zhejiang University
Hangzhou, 310020
ChinaSite Not Available
Harbin medical university cancer hospital
Harbin, 150000
ChinaSite Not Available
Jiangsu Province Hospital
Nanjing, 210029
ChinaSite Not Available
Nanjing Drum Tower Hospital
Nanjing, 210008
ChinaSite Not Available
Zhongda Hospital Southeast University
Nanjing, 210009
ChinaSite Not Available
Zhongda Hospital,Southeast University
Nanjing, 210009
ChinaSite Not Available
The Affiliated Hospital of Medical College Qingdao University
Qingdao, 266003
ChinaSite Not Available
Renji Hospital, Shanghai Jiaotong University School of Medicine
ShangHai, 200127
ChinaSite Not Available
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai, 200025
ChinaSite Not Available
Shanghai Changzheng Hospital
Shanghai, 200003
ChinaSite Not Available
Shanghai Zhongshan Hospital
Shanghai, 200032
ChinaSite Not Available
First Affiliated Hospital SooChow University
Suzhou, 215006
ChinaSite Not Available
First Affiliated Hospital, SooChow University
Suzhou, 215006
ChinaSite Not Available
Institute of Hematology & Blood Diseases Hospital
Tianjin, 300320
ChinaSite Not Available
Institute of Hematology and Blood Diseases Hospital
Tianjin, 300320
ChinaSite Not Available
Tianjin cancer hospital
Tianjin, 300040
ChinaSite Not Available
Institute of Hematology & Blood Diseases Hospital
Tianjin, China, 300320
ChinaSite Not Available
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
ChinaSite Not Available
Tongji Hospital, Tongji Medical College of HUST
Wuhan, 430030
ChinaSite Not Available
Tangdu Hospital
Xian, 710038
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, 450008
ChinaSite Not Available
Queen Mary Hospital University of Hong Kong
Hong Kong,
Hong KongSite Not Available
Queen Mary Hospital, University of Hong Kong
Hong Kong,
Hong KongSite Not Available
Inje University Busan Paik Hospital
Busan, 47392
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Korea, Republic ofSite Not Available
Chonnam National University Hwasun Hospital
Hwasun Gun, 58128
Korea, Republic ofSite Not Available
Gachon University Gil Medical Center
Incheon, 405-760
Korea, Republic ofSite Not Available
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, 13620
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic ofSite Not Available
Ulsan University Hospital
Ulsan, 44033
Korea, Republic ofSite Not Available
Hospital Ampang
Ampang, 68000
MalaysiaSite Not Available
Hospital Pulau Pinang
George Town, 10990
MalaysiaSite Not Available
Hospital Queen Elizabeth
Kota Kinabalu, 88586
MalaysiaSite Not Available
National Taiwan University Hospital
Taipei, 10048
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available
Chang Gung Memorial Hospital
Taoyuan, 33305
TaiwanSite Not Available
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