Clinical Trial 18156

Cancer Type: Multiple Myeloma
Interventions:CC-5013 (Lenalidomide); Dexamethasone; Lenalidomide (Revlimid); carfilzomib (Kyprolis)

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Melissa Alsina

Overview

Study Title

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

Summary

The purpose of this study is to find out more about carfilzomib in people with multiple myeloma, a cancer that affects how normal blood cells grow and work. This study will determine what amount (or dose) of carfilzomib taken once a week with lenalidomide and dexamethasone is safe for people to take and whether it causes any side effects.

Objective

Primary Objective * To evaluate the safety and tolerability of a once-weekly carfilzomib, lenalidomide,and dexamethasone (KRd) regimen Secondary Objectives * To evaluate the pharmacokinetics (PK) of carfilzomib when administered once weekly in a KRd regimen * To evaluate the clinical activity (efficacy) of a once-weekly KRd regimen Exploratory Objectives * To explore the genomic and transcriptional biomarkers that might predict response and resistance to a once-weekly KRd regimen * To characterize the pharmacodynamics (PDn) of proteasome inhibition with a once-weekly KRd regimen * To assess minimal residual disease (MRD) status with a once-weekly KRd regimen * To assess subject convenience and satisfaction with a once-weekly KRd regimen using subject questionnaire

Inclusion Criteria

  • Age 18 years or older
  • Newly diagnosed or relapsed multiple myeloma
  • Measureable disease by Serum M protein, or Urine M protein, or serum free light chain (SFLC) and an abnormal serum kappa lambda ratio (for participants without detectable serum or urine M-protein), or Serum quantitative immunoglobulin A (qlgA) (for immunoglobulin (Ig) A participants whose disease can only be reliable measured by qlgA).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2
  • Left ventricular ejection fraction (LVEF) ≥ 40%
  • Additional criteria may apply

  • Exclusion Criteria

  • Waldenstrom macroglobulinemia
  • For newly diagnosed multiple myeloma: multiple myeloma of IgM subtype
  • For relapsed disease: a) If treated with a lenalidomide and dexamethasone-containing combination, progression during the first 3 months after initiating treatment. b) Any progression during treatment if the lenalidomide and dexamethasone-containing regimen was the most recent line of therapy. c) Any prior treatment with carfilzomib
  • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  • Plasma cell leukemia (> 2.0 X 10^9/L circulating plasma cells by standard differential)
  • Myelodysplastic syndrome
  • Amyloidosis
  • Prior treatment with carfilzomib or oprozomib
  • Additional criteria may apply