Study of the Bruton's Tyrosine Kinase Inhibitor in Combination With Carfilzomib (Kyprolis™) in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:10/10/2018
Start Date:December 2013
End Date:April 2019

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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

Phase 1 will be an open-label study. The dose escalation portion of the study is designed to
establish the MTD of ibrutinib in combination with carfilzomib with or without dexamethasone.

Phase 2b will be an open-label, multicenter study designed to evaluate the overall response
rate when ibrutinib is administered in combination with carfilzomib and dexamethasone.

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. PCI-32765 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 PCI-32765 in combination with carfilzomib (Kyprolis™)
with and without dexamethasone in subjects with relapsed or relapsed and refractory multiple
myeloma (MM).

Inclusion Criteria:

- Measurable disease of MM as defined by at least ONE of the following:

1. Serum monoclonal protein (SPEP) ≥1 g/dL

2. Urine M-protein ≥200 mg/24 hrs

3. 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:

1. Achieved less than a partial response ( without evidence of progression disease (PD).

OR

2. Disease progression following an initial confirmed response of MR or better to
the combination (according to IMWG response criteria).

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 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
We found this trial at
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-444-9814
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Los Angeles, California 90095
310-825-4321
Phone: 310-794-0242
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Charleston, South Carolina 29425
Phone: 843-792-8856
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Charlotte, North Carolina 28203
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Phone: 513-584-0439
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Phone: 214-648-7030
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
720-754-4800
Phone: 720-754-4891
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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Duarte, California 91010
Phone: 626-218-0830
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-668-6524
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Montreal, Quebec
Phone: (514) 934-1934 xext35718
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New York, New York 10021
Phone: 646-962-9338
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New York, New York 10029
Phone: 212-241-2592
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Phone: 402-559-4135
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-503-3037
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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San Antonio, Texas 78229
Phone: 210-575-4281
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