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

NCT ID: NCT01962792

Last Updated: 2021-12-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2019-03-31

Brief Summary

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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

Detailed Description

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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).

Conditions

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Multiple Myeloma

Keywords

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PCI-32765 Multiple Myeloma Relapsed Refractory Multiple Myeloma Bruton's Tyrosine Kinase Carfilzomib Dexamethasone Ibrutinib

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1 - Dose Finding

Ibrutinib PO 560mg + Carfilzomib IV 20/27mg/m2 + Dexamethasone PO 20mg

Group Type EXPERIMENTAL

Ibrutinib

Intervention Type DRUG

Carfilzomib

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Phase 2b - Main Study

Ibrutinib PO 560mg + Carfilzomib IV 20/36mg/m2 + Dexamethasone PO 20mg

Group Type EXPERIMENTAL

Ibrutinib

Intervention Type DRUG

Carfilzomib

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Phase 2b - Sub-study

Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg

Group Type EXPERIMENTAL

Ibrutinib

Intervention Type DRUG

Carfilzomib

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Interventions

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Ibrutinib

Intervention Type DRUG

Carfilzomib

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Eligibility Criteria

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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


* 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 (\<PR) following at least 4 cycles and are 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmacyclics LLC.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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City of Hope

Duarte, California, United States

Site Status

University of California Los Angeles

Los Angeles, California, United States

Site Status

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

New York Presbyterian Hospital - Weill-Cornell

New York, New York, United States

Site Status

Mount Sinai Hospital

New York, New York, United States

Site Status

Carolinas Healthcare System

Charlotte, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

MUSC Hollings Cancer Center

Charleston, South Carolina, United States

Site Status

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Methodist Healthcare System

San Antonio, Texas, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

McGill University

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Ibrutinib (PCI-32765)

Identifier Type: -

Identifier Source: secondary_id

PCYC-1119-CA

Identifier Type: -

Identifier Source: org_study_id