Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma

Part of paid clinical trials in Duarte, California.

Sponsor
Pharmacyclics LLC.
Study ID
NCT02548962
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
  • Pomalidomide — DRUG
  • Dexamethasone — DRUG
  • Placebo — DRUG

Study Details

Phase 1 is an open-label, dose finding, multicenter study of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma. Phase 2b is a randomized, double-blind, multicenter study of ibrutinib or placebo, in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.

Key Dates

Start date
Mar 31, 2016
Status verified
Nov 2019
Primary completion
Jun 13, 2018
Completion
Jun 13, 2018

Study Design

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

Arms

  • Experimental: Phase 1: Dose Finding
    Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
  • Experimental: Phase 2: Treatment Arm A
    Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO
  • Experimental: Phase 2: Treatment Arm B
    Placebo PO+ Pomalidomide PO+ Dexamethasone PO

Primary Outcome Measure

Overall Response Rate (ORR) According to the IMWG Response Criteria Per Investigator Assessment [ Time Frame: 14 Months ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Cleveland ClinicClevelandOhio44195-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Virginia Commonwealth UniversityRichmondVirginia23298-

Find similar trials in Duarte, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
City of Hope· Duarte, CADana-Farber Cancer Institute· Boston, MACleveland Clinic· Cleveland, OHMedical University of South Carolina· Charleston, SCVirginia Commonwealth University· Richmond, VA

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