Daratumumab in Treating Transplant-Eligible Participants With Multiple Myeloma

Overview

This phase II trial studies how well daratumumab works in treating transplant-eligible patients with multiple myeloma.

SparkCures ID 1052
Trial Phase Phase 2
Enrollment 50 Patients
Treatments
Tags
Trial Sponsors
  • Mayo Clinic
Trial Collaborators
  • National Cancer Institute (NCI)
NCT Identifier

NCT03477539

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Pathologically confirmed diagnosis of multiple myeloma who are transplant eligible and have received any prior induction therapy (with or without maintenance)
  • Measurable MRD in bone marrow within 28 days prior to registration (MPF method)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 at registration
  • Absolute neutrophil count (ANC) >= 1,000 cell/mm^3 without growth factor support, obtained =< 14 days prior to registration
  • Platelets >= 50,000 cells/mm^3 for patients who have bone marrow plasmacytosis < 50% or >= 30,000 cells/mm^3 for patients who have bone marrow plasmacytosis of >= 50%, obtained =< 14 days prior to registration
  • Calculated or measured creatinine clearance >= 30 ml/min, obtained =< 14 days prior to registration
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) unless due to Gilbert?s syndrome, in which case the direct bilirubin must be =< 1.5 X ULN, obtained =< 14 days prior to registration
  • Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) =< 3 x ULN, obtained =< 14 days prior to registration
  • Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 X ULN, obtained =< 14 days prior to registration
  • Negative urine or serum pregnancy test for women of childbearing potential
    • NOTE: females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
  • Provide informed written consent
  • Willing to provide bone marrow aspirate and core, and blood samples for correlative research purposes
  • Measurable disease of multiple myeloma at the time of baseline values for disease assessment as defined by at least one of the following:
    • Serum monoclonal protein >= 1.0 g/dL
    • >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
    • Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio ? Bone marrow plasma cells >= 30%

Exclusion Criteria:

  • Any previous ASCT for multiple myeloma (MM)
  • Any prior therapy with daratumumab
  • Non-secretory MM or known amyloid light-chain (AL) amyloidosis
  • Clinically significant active infection requiring intravenous antibiotics (=< 14 days prior to registration)
  • >= grade 3 neuropathy and/or polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS syndrome)
  • Other prior malignancy
    • Exceptions:

      • Adequately treated basal cell or squamous cell skin cancer
      • Any in situ cancer
      • Adequately treated stage I or II cancer from which the patient is currently in complete remission, or
      • Any other cancer from which the patient has been disease free for at least 3 years
  • Concurrent therapy considered investigational

    • NOTE: patients must not be planning to receive any radiation therapy (except localized radiation for palliative care that must be completed prior to starting cycle 1, day 1)
  • Pregnant women
  • Nursing women (lactating females are eligible provided that they agree not to breast feed while taking lenalidomide)
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Major surgery =< 4 weeks prior to registration
  • History of stroke/intracranial hemorrhage =< 6 months prior to registration
  • Clinically significant cardiac illness including New York Heart Association (NYHA) class III or class IV heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, or >= grade 3 cardiac arrhythmias noted =< 14 days prior to registration
  • Known human immunodeficiency virus positive (HIV+) patients
  • Known hepatitis B or hepatitis C infection
  • Exhibiting clinical signs of meningeal involvement of multiple myeloma
  • Known severe chronic obstructive pulmonary disease or asthma defined as forced expiratory volume (FEV1) in 1 second less than < 60% of expected

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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