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

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT02548962

Run by

Pharmacyclics LLC.

People needed

11

Starts

2016-03-01

Expected to finish

2018-06-13

Last updated by the study team

2019-11-21

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Serum monoclonal protein (SPEP) ≥1 g/dL.
• Urine monoclonal protein (UPEP) ≥200 mg by 24 hour urine.
• Adequate hematologic, hepatic, and renal function
• ECOG performance status of ≤ 2

You may not qualify if…

• 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.

Where it is running

• City of Hope — Duarte, California, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Concord Repatriation General Hospital — Concord, New South Wales, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Fakultni nemocnice Brno — Brno, Czechia
• Fakultni nemocnice Ostrava — Ostrava, Czechia
• Vseobecna fakultni nemocnice v Praze — Prague, Czechia
• Universitätsklinikum Carl Gustav Carus — Dresden, Germany
• 'Alexandra' General Hospital of Athens — Athens, Attica, Greece
• Clinica Universidad de Navarra — Pamplona, Navarre, Spain
• Hospital de La Santa Creu i Sant Pau — Barcelona, Spain
• Hospital Universitario de Salamanca — Salamanca, Spain
• Hospital Universitario Doctor Peset — Valencia, Spain

Full record on ClinicalTrials.gov

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