A Study of DARZALEX (Daratumumab) In Indian Participants With Relapsed and Refractory Multiple Myeloma, Whose Prior Therapy Included a Proteasome Inhibitor and an Immunomodulatory Agent

Last updated: January 31, 2025
Sponsor: Johnson & Johnson Private Limited
Overall Status: Completed

Phase

4

Condition

Bone Neoplasm

Platelet Disorders

Leukemia

Treatment

Daratumumab

Clinical Study ID

NCT03768960
CR108556
54767414MMY4008
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to demonstrate the safety profile of daratumumab in routine clinical practice when given as monotherapy in Indian participants with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with relapsed and refractory multiple myeloma (as per InternationalMyeloma Working Group [IMWG] definitions) whose prior therapy included a proteasomeinhibitor and an immunomodulatory agent, being newly initiated on DARZALEX (daratumumab) monotherapy based on independent clinical judgment of treatingphysicians as per locally approved prescribing information

  • Each participant (or their legally acceptable representative) must sign an informedconsent form (ICF) indicating that he or she understands the purpose of andprocedures required for the study and are willing to participate in the study.Participants must be willing and able to adhere to the prohibitions and restrictionsspecified in this protocol, as referenced in the informed consent form (ICF)

Exclusion

Exclusion Criteria:

  • Participants who are not eligible to receive DARZALEX as per the locally approvedprescribing information

  • Participant participating or planning to participate in any interventional drugtrial during the course of this study

  • Known seropositive for human immunodeficiency virus (HIV)

  • Seropositive for hepatitis B (defined by a positive test for hepatitis B surfaceantigen [HBsAg]). Participants with resolved infection (that is, participants whoare HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must bescreened using real-time polymerase chain reaction (PCR) measurement of hepatitis Bvirus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will beexcluded. exception: Participants with serologic findings suggestive of HBVvaccination (anti-HBs positivity as the only serologic marker) and a known historyof prior HBV vaccination, do not need to be tested for HBV DNA by PCR

  • Known seropositive for hepatitis C (except in the setting of a sustained virologicresponse [SVR], defined as aviremia at least 12 weeks after completion of antiviraltherapy)

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Daratumumab
Phase: 4
Study Start date:
June 10, 2019
Estimated Completion Date:
July 16, 2022

Connect with a study center

  • Avron Hospitals Pvt. Ltd

    Ahmedabad, 380013
    India

    Site Not Available

  • M S Ramaiah Medical College and Hospital

    Bengaluru, 560054
    India

    Site Not Available

  • Sparsh Hospitals & Critical Care (Pvt) Ltd

    Bhubaneshwar, 751007
    India

    Site Not Available

  • Apollo Hospitals

    Bhubaneswar, 751005
    India

    Site Not Available

  • Post Graduate Institute of Medical Education & Research (PGIMER)

    Chandigarh, 160012
    India

    Site Not Available

  • Post Graduate Institute of Medical Education And Research PGIMER

    Chandigarh, 160012
    India

    Site Not Available

  • Apollo Hospitals

    Hyderabad, 500033
    India

    Site Not Available

  • Basavatarakam Indo-American Hospital

    Hyderabad, 500034
    India

    Site Not Available

  • Cytecare Hospitals Pvt. Ltd

    Karnataka, 560064
    India

    Site Not Available

  • Tata Medical Center

    Kolkata, 700156
    India

    Site Not Available

  • Christian Medical College

    Ludhiana, 141008
    India

    Site Not Available

  • Tata Memorial Hospital

    Mumbai, 400012
    India

    Site Not Available

  • Shatabdi Super Speciality Hospital

    Mumbai Naka, 422005
    India

    Site Not Available

  • Kingsway Hospital

    Nagpur, 440001
    India

    Site Not Available

  • Apex Wellness Hospital

    Nashik, 422009
    India

    Site Not Available

  • All India Institute of Medical Sciences

    New Delhi, 110029
    India

    Site Not Available

  • Jawaharlal Institute of Postgraduate Medical Education and Research

    Pondicherry, 605008
    India

    Site Not Available

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, 411004
    India

    Site Not Available

  • Noble Hospital Pvt Ltd

    Pune, 411013
    India

    Site Not Available

  • Regional Cancer Centre

    Thiruvananthapuram, 695011
    India

    Site Not Available

  • Christian Medical College

    Vellore, 632004
    India

    Site Not Available

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