Phase 1b Study of Carfilzomib Administered Once Weekly in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma
Investigator: Bill G Schmidt, MD
Sponsor: Onyx Therapeutics, Inc.
Contact: Jennifer Montgomery, 541-706-6590 or firstname.lastname@example.org
Location: Bend, Oregon (Central Oregon)
Purpose: 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.
- 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 subjects without detectable serum or urine M-protein), or Serum quantitative immunoglobulin A (qlgA) (for immunoglobulin (Ig) A subjects whose disease can only be reliable measured by qlgA).
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1
- Left ventricular ejection fraction (LVEF) ≥ 40%
- Waldenström macroglobulinemia
- For newly diagnosed multiple myeloma: multiple myeloma of IgM subtype
- For relapsed disease:
- If treated with a lenalidomide and dexamethasone combination, progression during the first 3 months after initiating treatment.
- Any progression during treatment if the lenalidomide and dexamethasone regimen was the most recent line of therapy.
- Any prior treatment with carfilzomib
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
- Myelodysplastic syndrome
- Prior treatment with carfilzomib or oprozomib
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