Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • 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
    • 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


    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


    Karmanos Cancer Institute - Detroit Headquarters

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

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

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