Study of BTK Inhibitor, Ibrutinib in Combination With Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma
A Multicenter Phase 1/2b Study of the Bruton's Tyrosine Kinase Inhibitor, Ibrutinib (PCI-32765), in Combination With Carfilzomib (Kyprolis™) in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma
2 other identifiers
interventional
84
2 countries
17
Brief Summary
A MULTICENTER PHASE 1/2B STUDY OF THE BRUTON'S TYROSINE KINASE INHIBITOR, IBRUTINIB (PCI-32765), IN COMBINATION WITH CARFILZOMIB (KYPROLIS™) IN SUBJECTS WITH RELAPSED OR RELAPSED AND REFRACTORY MULTIPLE MYELOMA
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 multiple-myeloma
Started Dec 2013
Typical duration for phase_1 multiple-myeloma
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2013
CompletedFirst Posted
Study publicly available on registry
October 14, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedResults Posted
Study results publicly available
December 21, 2021
CompletedDecember 21, 2021
November 1, 2021
5.2 years
September 27, 2013
April 6, 2020
November 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
-To evaluate the overall response (ORR) of ibrutinib in combination with carfilzomib and dexamethasone.
up to 4 years
Secondary Outcomes (3)
Duration of Response (DOR)
Up to 4 years
Overall Survival
Up to 4 years
Progression Free Survival (PFS)
Up to 4 years
Study Arms (3)
Phase 1 - Dose Finding
EXPERIMENTALIbrutinib PO 560mg + Carfilzomib IV 20/27mg/m2 + Dexamethasone PO 20mg
Phase 2b - Main Study
EXPERIMENTALIbrutinib PO 560mg + Carfilzomib IV 20/36mg/m2 + Dexamethasone PO 20mg
Phase 2b - Sub-study
EXPERIMENTALIbrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg
Interventions
Eligibility Criteria
You may qualify if:
- Measurable disease of MM as defined by at least ONE of the following:
- Serum monoclonal protein (SPEP) ≥1 g/dL
- Urine M-protein ≥200 mg/24 hrs
- Serum free light chain (SFLC): involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal kappa to lambda serum free light chain ratio
- Relapsed or relapsed and refractory MM after receiving at least 2 previous therapies, including an immunomodulator and bortezomib and had either no response or documented disease progression (according to IMWG criteria) to the most recent treatment regimen
- Adequate hematologic, hepatic, and renal function
- ECOG performance status of 0-2
- Subject must have received a regimen containing carfilzomib in combination with dexamethasone as their most recent line of therapy and have:
- Achieved less than a partial response (\<PR) following at least 4 cycles and are without evidence of progression disease (PD).
- Disease progression following an initial confirmed response of MR or better to the combination (according to IMWG response criteria).
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 anti-coagulation with warfarin or a vitamin K antagonist
- Requires treatment with strong CYP3A inhibitors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
City of Hope
Duarte, California, 91010, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
New York Presbyterian Hospital - Weill-Cornell
New York, New York, 10021, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Carolinas Healthcare System
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Methodist Healthcare System
San Antonio, Texas, 78229, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
McGill University
Montreal, Quebec, QC H4A 3J1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thorsten Graef, Head of Clinical Development
- Organization
- Pharmacyclics LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2013
First Posted
October 14, 2013
Study Start
December 1, 2013
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
December 21, 2021
Results First Posted
December 21, 2021
Record last verified: 2021-11