Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed/Relapsed and Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 2018-10-26
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2 open-label study to evaluate the efficacy and safety of ibrutinib in combination with bortezomib and dexamethasone for patients with relapsed or relapsed and refractory multiple myeloma.

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

Details

• Lead Sponsor: Pharmacyclics LLC.; Pharmacyclics Switzerland GmbH
• Collaborator: Janssen Research & Development, LLC
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Subjects with multiple myeloma (MM) who have received 1-3 prior lines of therapy and have demonstrated disease progression since the completion of the most recent treatment regimen. (Subjects may have received prior bortezomib exposure if it does not meet the exclusion criteria for prior proteasome inhibitor use)

• Measurable disease defined by at least one of the following:

• Serum monoclonal protein (SPEP) ≥1 g/dL (for subjects with immunoglobulin A (IgA), immunoglobulin D (IgD), immunoglobulin E (IgE) or immunoglobulin M (IgM) multiple myeloma SPEP ≥0.5 g/dL)

• Urine monoclonal protein (UPEP) ≥200 mg by 24 hour urine electrophoresis

• Adequate hematologic, hepatic and renal function

• Eastern Cooperative Oncology Group (ECOG) performance status of ≤2

Exclusion Criteria:

• Subject must not have primary refractory disease

• Refractory or non-responsive to prior proteasome inhibitor (PI) therapy (bortezomib or carfilzomib)

• Peripheral neuropathy Grade ≥2 or Grade 1 with pain at Screening

• Plasma cell leukemia, primary amyloidosis, or POEMS syndrome

• Unable to swallow capsules or disease significantly affecting gastrointestinal function

• Requires treatment with strong CYP3A inhibitors

• Women who are pregnant or breast feeding