Overview

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