A Study to Compare Daratumumab, Bortezomib, and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Chinese Participants With Relapsed or Refractory Multiple Myeloma

Last updated: May 27, 2024
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

3

Condition

Multiple Myeloma

Leukemia

Cancer/tumors

Treatment

Dexamethasone

Velcade

Daratumumab

Clinical Study ID

NCT03234972
CR104378
54767414MMY3009
  • Ages > 18
  • All Genders

Study Summary

The primary purpose of this study is to compare the efficacy of daratumumab when combined with Velcade (bortezomib) and dexamethasone (DVd) to that of Velcade and dexamethasone (Vd), in terms of progression free survival (PFS) in Chinese participants with relapsed or refractory multiple myeloma (MM).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented multiple myeloma (MM) as defined by the criteria: monoclonal plasma cellsin the bone marrow greater than or equal to (>=) 10 percent (%) at some point in theparticipant's disease course or presence of a biopsy-proven plasmacytoma

  • Received at least 1 prior line of therapy for MM

  • Documented evidence of progressive disease (PD) based on investigator'sdetermination of response as defined by the International Myeloma Working Group (IMWG) criteria on or after their last regimen

  • Achieved a response (partial response [PR] or better based on investigator'sdetermination of response by the IMWG criteria) to at least 1 prior regimen

  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2

Exclusion

Exclusion Criteria:

  • Received daratumumab or other anti-CD38 therapies

  • Refractory to Velcade, or another proteasome inhibitor (PI), like ixazomib andcarfilzomib (ie, participant had progression of disease while receiving Velcadetherapy or within 60 days of ending Velcade therapy, or another PI, like ixazomiband carfilzomib, etc)

  • Intolerant to Velcade (that is [ie], discontinued due to any adverse event while onVelcade treatment)

  • Planning to undergo a stem cell transplant prior to progression of disease on thisstudy, that is ie, these participants should not be enrolled in order to reducedisease burden prior to transplant

  • History of malignancy (other than MM) within 3 years before the date ofrandomization

Study Design

Total Participants: 213
Treatment Group(s): 3
Primary Treatment: Dexamethasone
Phase: 3
Study Start date:
November 30, 2017
Estimated Completion Date:
February 27, 2024

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, 100032
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, 100034
    China

    Site Not Available

  • Peking University People s Hospital

    Beijing, 100044
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, 100044
    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

  • West China Hospital Si Chuan University

    Chengdu, 610041
    China

    Site Not Available

  • West China Hospital, Si Chuan University

    Chengdu, 610041
    China

    Site Not Available

  • Xinqiao Hospital of the Third Military 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

  • 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

  • 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

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025
    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

  • 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 Medical University General Hospital

    Tianjin, 300052
    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

  • 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

  • National Taiwan University Hospital

    Taipei, 10048
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei, 11490
    Taiwan

    Site Not Available

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