Overview

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

Status:
Terminated

Trial end date:
2018-06-13

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pharmacyclics LLC.

Collaborator:

Celgene Corporation

Treatments:

BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Pomalidomide
Thalidomide

Criteria

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.