Study of BTK Inhibitor, Ibrutinib in Combination With Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma

Completed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

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

Key facts

Study ID

NCT01962792

Run by

Pharmacyclics LLC.

People needed

84

Starts

2013-12-01

Expected to finish

2019-03-01

Last updated by the study team

2021-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Inclusion Criteria for Phase 2 Sub-study Cohort:
• Must meet all inclusion criteria defined in main study and in addition the following criteria must be met:
• 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).
• OR
• 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
• Exclusion Criteria for Phase 2 Sub-study Cohort:
• Must not meet any exclusion criteria defined in main study except for exclusion criteria "Subject must not have primary refractory disease" which is related to prior carfilzomib

Where it is running

• City of Hope — Duarte, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• New York Presbyterian Hospital - Weill-Cornell — New York, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• Carolinas Healthcare System — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• MUSC Hollings Cancer Center — Charleston, South Carolina, United States
• Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Methodist Healthcare System — San Antonio, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• McGill University — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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