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

NCT ID: NCT02548962

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-06-13

Brief 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.

Detailed Description

Bruton's tyrosine kinase (Btk) is an enzyme that is present in hematopoietic cells other than T cells and is necessary for downstream signal transduction from various hematopoietic receptors including the B cell receptor as well as some Fc, chemokine, and adhesion receptors, and is crucial for both B cell development and osteoclastogenesis. Although down-regulated in normal plasma cells, Btk is highly expressed in the malignant cells from many myeloma patients and some cell lines. Ibrutinib is a potent and specific inhibitor of Btk currently in Phase 2 and 3 clinical trials. The current study is designed and intended to determine the safety and efficacy of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Phase 1: Dose Finding

Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO

Group Type: EXPERIMENTAL

Ibrutinib

Intervention Type: DRUG

Pomalidomide

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Phase 2: Treatment Arm A

Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO

Group Type: EXPERIMENTAL

Ibrutinib

Intervention Type: DRUG

Pomalidomide

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Phase 2: Treatment Arm B

Placebo PO+ Pomalidomide PO+ Dexamethasone PO

Group Type: EXPERIMENTAL

Pomalidomide

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Interventions

Ibrutinib

Intervention Type: DRUG

Pomalidomide

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Pharmacyclics LLC.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States; Australia; Czechia; Germany; Greece; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PCI-32765

Identifier Type: OTHER

Identifier Source: secondary_id

PCYC-1138-CA

Identifier Type: -

Identifier Source: org_study_id