A Phase 1 Trial Studying the Best Dose and Safety of MEDI2228 in Patients with Relapsed/Refractory Multiple Myeloma

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Overview

This phase 1 trial is studying the best dose and safety of MEDI2228 in patients with relapsed/refractory multiple myeloma.

SparkCures ID 951
Trial Phase Phase 1
Enrollment 142 Patients
Treatments
Tags
Trial Sponsors
  • MedImmune
NCT Identifier

NCT03489525

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:

  1. Subjects must be ≥ 18 years of age at the time of screening.
  2. Subjects must have a confirmed diagnosis of relapsed/refractory MM as per IMWG criteria (Rajkumar et al, 2014) and have exhausted standard of care regimens with proven clinical benefit, which include agents from the following anti myeloma therapies: PIs, IMIDs, and mAbs and have measurable disease with at least one of the following criteria:
    1. Serum M-protein ≥ 0.5 g/dL
    2. Urine M-protein ≥ 200 mg/24 hours
    3. Serum free light chain (FLC) assay: involved FLC level ≥ 10 mg/dL provided serum FLC ratio is abnormal.
  3. Subjects must either be ineligible for or post-autologous stem cell transplant.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  5. Adequate organ and marrow functions as determined per protocol-defined criteria.

Exclusion Criteria

Any of the following would exclude the subject from participation in the study:

Target Disease:

  1. Subjects who have previously received an autologous stem cell transplant if less than 90 days have elapsed from the time of transplant or the subject has not recovered from transplant associated toxicities prior to the first scheduled dose of MEDI2228
  2. Subjects who have previously received an allogeneic stem cell transplant
  3. Central nervous system (CNS) involvement(including meningeal involvement) by MRI or cerebrospinal fluid exam
  4. Known history of polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome, plasma cell leukemia, Waldenstrom's macroglobulinemia, or amyloidosis

    Medical History and Concurrent Diseases:

  5. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results

US Trial Locations

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

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