Phase 1b Study of Carfilzomib Administered Once Weekly in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma

Overview

The purpose of the study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of a once-weekly regimen of carfilzomib in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma.
SparkCures ID 702
Trial Phase Phase 1
Enrollment 84 Patients
Treatments
Trial Sponsors
  • Amgen
NCT Identifier

NCT02335983

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.

Key Inclusion Criteria:

  1. Newly diagnosed or relapsed multiple myeloma
  2. Measurable disease by Serum M protein, or Urine M protein, or Serum quantitative immunoglobulin (qIgA) (for immunoglobulin (Ig) A subjects whose disease can only be reliably measured by qIgA)
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1
  4. Left ventricular ejection fraction (LVEF) ≥ 40%

Key Exclusion Criteria:

  1. Waldenström macroglobulinemia
  2. For newly diagnosed multiple myeloma: multiple myeloma of IgM subtype
  3. For relapsed disease:
    1. If treated with a lenalidomide and dexamethasone combination, progression during the first 3 months after initiating treatment.
    2. Any progression during treatment if the lenalidomide and dexamethasone regimen was the most recent line of therapy.
    3. Any prior treatment with carfilzomib
  4. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  5. Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard differential)
  6. Myelodysplastic syndrome
  7. Amyloidosis
  8. Prior treatment with carfilzomib or oprozomib

US Trial Locations

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

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