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  • A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) Amyloidosis

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2022-052
    NCT ID
    • NCT05250973
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II
    Principal Investigator
    • Jeffrey
      Zonder, M.D.

      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    Primary Objectives:

    Cohort 1:

    • to characterize cardiac safety of different D-VCd treatment regimens (Arm A: immediate daratumumab + VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic AL amyloidosis with cardiac involvement and to identify potential mitigation strategies (monitoring of cardiac health/performance via ECG, echocardiography [ECHO], 6 min walk test, biomarkers [TroponinT, HS TroponinT, and NT-proBNP] to inform clinical mitigation strategies alongside comparison of different treatment schedules) for cardiac toxicity.

    Cohort 2:

    • To characterize the PK of SC daratumumab, among racial and ethnic minorities, including Black or African American, with newly diagnosed systemic AL amyloidosis treated with D-VCd.

    Secondary Objectives:

    • To evaluate efficacy measures
    • To assess the safety profile, including cardiac events
    • To characterize the PK of SC daratumumab
    • To assess the immunogenicity of SC daratumumab
    • To monitor the clinical signs and symptoms of cardiac AL amyloidosis to identify possible predictive factors for cardiac events
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266