A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region)

Last updated: April 24, 2024
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

3

Condition

Multiple Myeloma

Red Blood Cell Disorders

Cancer

Treatment

Daratumumab

Melphalan

Prednisone

Clinical Study ID

NCT03217812
CR108340
54767414MMY3011
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine if the addition of daratumumab to VELCADE-melphalan-prednisone (VMP) will improve very good partial response (VGPR) or better compared with VMP alone.

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

Total Participants: 220
Treatment Group(s): 4
Primary Treatment: Daratumumab
Phase: 3
Study Start date:
November 23, 2017
Estimated Completion Date:
March 08, 2024

Connect with a study center

  • Beijing Chaoyang Hospital

    Beijing, 100020
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, 100032
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, 100034
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, 100083
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, 130021
    China

    Site Not Available

  • The Third Xiangya Hospital, Central South University

    Changsha, 410013
    China

    Site Not Available

  • West China Hospital Si Chuan University

    Chengdu, 610041
    China

    Site Not Available

  • West China Hospital, Si Chuan University

    Chengdu, 610041
    China

    Site Not Available

  • Second Affiliated Hospital of Army Medical University

    Chongqing, 400037
    China

    Site Not Available

  • Fujian Meidical University Union Hospital

    Fuzhou, 350001
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080
    China

    Site Not Available

  • Nanfang Hospital

    Guangzhou, 510515
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510080
    China

    Site Not Available

  • First Affiliated Hospital Medical School of Zhejiang University

    Hangzhou, 310020
    China

    Site Not Available

  • First Affiliated Hospital, Medical School of Zhejiang University

    Hangzhou, 310020
    China

    Site Not Available

  • First affiliated Hospital of Zhejiang University

    Hangzhou, 310020
    China

    Site Not Available

  • Harbin medical university cancer hospital

    Harbin, 150000
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, 210029
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, 210008
    China

    Site Not Available

  • Zhongda Hospital Southeast University

    Nanjing, 210009
    China

    Site Not Available

  • Zhongda Hospital,Southeast University

    Nanjing, 210009
    China

    Site Not Available

  • The Affiliated Hospital of Medical College Qingdao University

    Qingdao, 266003
    China

    Site Not Available

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    ShangHai, 200127
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiao Tong University

    Shanghai, 200025
    China

    Site Not Available

  • Shanghai Changzheng Hospital

    Shanghai, 200003
    China

    Site Not Available

  • Shanghai Zhongshan Hospital

    Shanghai, 200032
    China

    Site Not Available

  • First Affiliated Hospital SooChow University

    Suzhou, 215006
    China

    Site Not Available

  • First Affiliated Hospital, SooChow University

    Suzhou, 215006
    China

    Site Not Available

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, 300320
    China

    Site Not Available

  • Institute of Hematology and Blood Diseases Hospital

    Tianjin, 300320
    China

    Site Not Available

  • Tianjin cancer hospital

    Tianjin, 300040
    China

    Site Not Available

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, China, 300320
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000
    China

    Site Not Available

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, 430030
    China

    Site Not Available

  • Tangdu Hospital

    Xian, 710038
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, 450008
    China

    Site Not Available

  • Queen Mary Hospital University of Hong Kong

    Hong Kong,
    Hong Kong

    Site Not Available

  • Queen Mary Hospital, University of Hong Kong

    Hong Kong,
    Hong Kong

    Site Not Available

  • Inje University Busan Paik Hospital

    Busan, 47392
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Hwasun Gun, 58128
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon, 405-760
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • Ulsan University Hospital

    Ulsan, 44033
    Korea, Republic of

    Site Not Available

  • Hospital Ampang

    Ampang, 68000
    Malaysia

    Site Not Available

  • Hospital Pulau Pinang

    George Town, 10990
    Malaysia

    Site Not Available

  • Hospital Queen Elizabeth

    Kota Kinabalu, 88586
    Malaysia

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10048
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital

    Taoyuan, 33305
    Taiwan

    Site Not Available

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