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

November 4, 2019 updated by: Pharmacyclics LLC.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
  • Czechia
      • Brno, Czechia, 625 00
        • Fakultni nemocnice Brno
      • Ostrava, Czechia, 708 52
        • Fakultni Nemocnice Ostrava
      • Praha, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze
  • Germany
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus
  • Greece
    • Attiki
      • Athens, Attiki, Greece, 11528
        • 'Alexandra' General Hospital of Athens
  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Valencia, Spain, 46017
        • Hospital Universitario Doctor Peset
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1: Dose Finding
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Drug: Dexamethasone
Drug: Pomalidomide
Drug: Ibrutinib
Experimental: Phase 2: Treatment Arm A
Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
Drug: Dexamethasone
Drug: Pomalidomide
Drug: Ibrutinib
Experimental: Phase 2: Treatment Arm B
Placebo PO+ Pomalidomide PO+ Dexamethasone PO
Drug: Placebo
Drug: Dexamethasone
Drug: Pomalidomide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) According to the IMWG Response Criteria Per Investigator Assessment
Time Frame: 14 Months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Benefit Response (CBR)
Time Frame: 14 Months
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
Duration of Response (DOR)
Time Frame: 14 Months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmacyclics LLC.

Collaborators

Celgene Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

June 13, 2018

Study Completion (Actual)

June 13, 2018

Study Registration Dates

First Submitted

September 3, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimate)

September 14, 2015

Study Record Updates

Last Update Posted (Actual)

November 21, 2019

Last Update Submitted That Met QC Criteria

November 4, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCYC-1138-CA
  • PCI-32765 (Other Identifier: Pharmacyclics)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe