Study of the Bruton's Tyrosine Kinase Inhibitor in Combination With Carfilzomib (Kyprolis™) in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1 will be an open-label study. The dose escalation portion of the study is designed to establish the MTD of ibrutinib in combination with carfilzomib with or without dexamethasone.

Phase 2b will be an open-label, multicenter study designed to evaluate the overall response rate when ibrutinib is administered in combination with carfilzomib and dexamethasone.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacyclics LLC.
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Measurable disease of MM as defined by at least ONE of the following:

1. Serum monoclonal protein (SPEP) ≥1 g/dL

2. Urine M-protein ≥200 mg/24 hrs

3. Serum free light chain (SFLC): involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal kappa to lambda serum free light chain ratio

• Relapsed or relapsed and refractory MM after receiving at least 2 previous therapies, including an immunomodulator and bortezomib and had either no response or documented disease progression (according to IMWG criteria) to the most recent treatment regimen

• Adequate hematologic, hepatic, and renal function

• ECOG performance status of 0-2

Inclusion Criteria for Phase 2 Sub-study Cohort:

• Must meet all inclusion criteria defined in main study and in addition the following criteria must be met:

• Subject must have received a regimen containing carfilzomib in combination with dexamethasone as their most recent line of therapy and have:

1. Achieved less than a partial response (without evidence of progression disease (PD).

OR

2. Disease progression following an initial confirmed response of MR or better to the combination (according to IMWG response criteria).

Exclusion Criteria:

• Subject must not have primary refractory disease

• Plasma cell leukemia, primary amyloidosis or POEMS syndrome

• Unable to swallow capsules or disease significantly affecting gastrointestinal function

• Requires anti-coagulation with warfarin or a vitamin K antagonist

• Requires treatment with strong CYP3A inhibitors

Exclusion Criteria for Phase 2 Sub-study Cohort:

• Must not meet any exclusion criteria defined in main study except for exclusion criteria "Subject must not have primary refractory disease" which is related to prior carfilzomib