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

Part of paid clinical trials in Duarte, California.

Sponsor
Pharmacyclics LLC.
Study ID
NCT01962792
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
  • Carfilzomib — DRUG
  • Dexamethasone — DRUG

Study Details

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 Dates

Start date
Dec 31, 2013
Status verified
Nov 2021
Primary completion
Mar 31, 2019
Completion
Mar 31, 2019

Study Design

Enrollment
84 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 - Dose Finding
    Ibrutinib PO 560mg + Carfilzomib IV 20/27mg/m2 + Dexamethasone PO 20mg
  • Experimental: Phase 2b - Main Study
    Ibrutinib PO 560mg + Carfilzomib IV 20/36mg/m2 + Dexamethasone PO 20mg
  • Experimental: Phase 2b - Sub-study
    Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: up to 4 years ]

Locations (16)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
University of California Los AngelesLos AngelesCalifornia90095-
Colorado Blood Cancer InstituteDenverColorado80218-
University of Nebraska Medical CenterOmahaNebraska68198-
Mount Sinai HospitalNew YorkNew York10029-
New York Presbyterian Hospital - Weill-CornellNew YorkNew York10021-
Carolinas Healthcare SystemCharlotteNorth Carolina28204-
Duke University Medical CenterDurhamNorth Carolina27705-
University of CincinnatiCincinnatiOhio45267-
Cleveland ClinicClevelandOhio44195-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
MUSC Hollings Cancer CenterCharlestonSouth Carolina29425-
Vanderbilt Ingram Cancer CenterNashvilleTennessee37232-
University of Texas Southwestern Medical CenterDallasTexas75390-
Methodist Healthcare SystemSan AntonioTexas78229-
Virginia Commonwealth UniversityRichmondVirginia23298-

Find similar trials in Duarte, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
City of Hope· Duarte, CAUniversity of California Los Angeles· Los Angeles, CAColorado Blood Cancer Institute· Denver, COUniversity of Nebraska Medical Center· Omaha, NEMount Sinai Hospital· New York, NYNew York Presbyterian Hospital - Weill-Cornell· New York, NY

Related Studies