Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02548962
Recruitment Status : Terminated (After completing Phase 1, the Sponsor elected not to move forward with Phase 2.)
First Posted : September 14, 2015
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Pharmacyclics LLC.

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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Ibrutinib Drug: Pomalidomide Drug: Dexamethasone Drug: Placebo Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
Study Start Date : March 2016
Actual Primary Completion Date : June 13, 2018
Actual Study Completion Date : June 13, 2018


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



Primary Outcome Measures :
  1. Overall Response Rate (ORR) According to the IMWG Response Criteria Per Investigator Assessment [ Time Frame: Up to 3 years ]
    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


Secondary Outcome Measures :
  1. Clinical Benefit Response (CBR) [ Time Frame: Up to 3 years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548962


Locations
Layout table for location information
United States, California
City of Hope
Duarte, California, United States, 91010
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Australia, New South Wales
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Australia, Queensland
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Czechia
Fakultni nemocnice Brno
Brno, Czechia, 625 00
Fakultni nemocnice Ostrava
Ostrava, Czechia, 708 52
Vseobecna fakultni nemocnice v Praze
Praha, Czechia, 128 08
Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Greece
'Alexandra' General Hospital of Athens
Athens, Attiki, Greece, 11528
Spain
Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Hospital de La Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Universitario Doctor Peset
Valencia, Spain, 46017
Sponsors and Collaborators
Pharmacyclics LLC.
Celgene Corporation
  Study Documents (Full-Text)

Documents provided by Pharmacyclics LLC.:
Study Protocol  [PDF] February 13, 2017
Statistical Analysis Plan  [PDF] June 26, 2018


Layout table for additonal information
Responsible Party: Pharmacyclics LLC.
ClinicalTrials.gov Identifier: NCT02548962     History of Changes
Other Study ID Numbers: PCYC-1138-CA
PCI-32765 ( Other Identifier: Sponsor )
First Posted: September 14, 2015    Key Record Dates
Results First Posted: April 23, 2019
Last Update Posted: April 23, 2019
Last Verified: March 2019
Keywords provided by Pharmacyclics LLC.:
Multiple Myeloma
Bruton's Tyrosine Kinase
PCI-32765
Pomalidomide
Dexamethasone
Relapsed Refractory Multiple Myeloma
Ibrutinib
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Thalidomide
Dexamethasone
Dexamethasone acetate
Pomalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents