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Multiple Myeloma Clinical Trials

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Janssen NOPRODMMY4001

Multiple Myeloma Patient Registry

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Lauren Downing, BS
    484-526-7936

    Lauren.downing@sluhn.org
  • Treatment Agent: N/A

    Synopsis: The purpose of this observational study is to collect information on how relapsed multiple myeloma is managed in the United States. Participation in this study will allow data collection on treatments that could improve future disease management.

    • Must sign, and/or their legally acceptable representative where applicable must sign, a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
    • Have a diagnosis of relapsed multiple myeloma [according to International Myeloma Working Group (IMWG) criteria] with 1 to 3 prior lines of therapy. (An induction regimen followed by autologous stem cell transplantation and single-agent maintenance therapy will be considered a single line of therapy.)
    • Participants must have initiated a new line of induction therapy that includes a proteasome inhibitor (PI) and/or immunomodulatory drug (IMiD) within 4 weeks prior to enrollment. A short course of corticosteroids is allowed prior to initiating the new line of induction therapy
    • Participant has plasma cell leukemia [greater than (>) 2.0 * 10^9 per liter] circulating plasma cells by standard differential), Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and/or skin changes), or amyloid light-chain amyloidosis
    • Participant has a life expectancy of less than 6 months
    • At the time of screening, participant is enrolled in an interventional clinical trial for multiple myeloma using an anti-neoplastic agent that is not currently approved by the United States (US) Food and Drug Administration (FDA) for this indication