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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02548962
• Other study ID #: PCYC-1138-CA
• Secondary ID: PCI-32765
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: March 2016
• Est. completion date: June 13, 2018

Study information

• Verified date: November 2019
• Source: Pharmacyclics LLC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: June 13, 2018
• Est. primary completion date: June 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Ibrutinib

• Pomalidomide

• Dexamethasone

• Placebo

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Pharmacyclics LLC.	Celgene Corporation

Countries where clinical trial is conducted

United States,  Australia,  Czechia,  Germany,  Greece,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR) According to the IMWG Response Criteria Per Investigator Assessment	The overall response rate, defined as the proportion of subjects achieving a best overall response of PR or better per investigator assessment per IMWG at or prior to initiation of subsequent anticancer therapy	14 Months
Secondary	Clinical Benefit Response (CBR)	The clinical benefit response, defined as the proportion of subjects achieving a best overall response of MR or better per investigator assessment per IMWG at or prior to initiation of subsequent anticancer therapy.	14 Months
Secondary	Duration of Response (DOR)	The time interval between the date of initial documentation of a response and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects not progressed/died. The censoring date is the last adequate tumor assessment date.	14 Months