Phase 1 will be an open-label, dose finding, multicenter study of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma. Phase 2b will be conducted as a randomized, double-blind, multicenter study of ibrutinib or placebo, in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.

SparkCures ID	866
Trial Phase	Phase 1/2
Enrollment	235 Patients
Treatments	Dexamethasone Ibrutinib Placebo Pomalidomide
Trial Sponsors	Pharmacyclics
NCT Identifier	NCT02548962

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

Subjects with relapsed/refractory MM who have received at least two prior lines of therapy including lenalidomide and either bortezomib or carfilzomib and have demonstrated disease progression on or within 60 days of the completion of the most recent treatment regimen.
Measurable disease defined by at least ONE of the following:
1. Serum monoclonal protein (SPEP) ≥1 g/dL.
2. Urine monoclonal protein (UPEP) ≥200 mg by 24 hour urine.
Adequate hematologic, hepatic, and renal function
ECOG performance status of ≤ 2

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 treatment with strong CYP3A inhibitors
Women who are pregnant or breast feeding.

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

Overview

Am I Eligible?

US Trial Locations