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

• Status: Completed
• Trial end date: 2019-10-28
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; Onyx Therapeutics, Inc.
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

Criteria

Key Inclusion Criteria:

1. Newly diagnosed or relapsed multiple myeloma

2. 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 (glgA) (for immunoglobulin (Ig) A subjects whose disease can only be reliable measured by qlgA).

3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2

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 × 10^9/L circulating plasma cells by standard differential)

6. Myelodysplastic syndrome

7. Amyloidosis

8. Prior treatment with carfilzomib or oprozomib