Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT01665794
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pomalidomide — DRUG
    Pomalidomide taken orally at assigned dose.
  • Carfilzomib — DRUG
    Carfilzomib given by intravenous (IV) infusion at assigned dose.
  • dexamethasone — DRUG
    Dexamethasone taken orally of given by IV infusion.
  • Daratumumab — DRUG
    Daratumumab given by intravenous (IV) infusion at assigned dose.

Study Details

The study will investigate the effects of adding carfilzomib to the combination of pomalidomide and dexamethasone in sequential dose escalation cohorts in patients with relapsed or refractory multiple myeloma. This portion of the study is complete. This study will also investigate the effects of adding daratumumab to the combination of carfilzomib, pomalidomide and dexamethasone.

Key Dates

Start date
Aug 13, 2012
Status verified
Nov 2025
Primary completion
Nov 14, 2025
Completion
Nov 14, 2025

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: PdC Group
    Patients receive carfilzomib, pomalidomide, and dexamethasone at indicated doses and schedule every 28 days. Patients may continue to receive treatment in the absence of disease progression or unacceptable toxicity.
  • Experimental: PdC + Dara Group
    Patients receive carfilzomib, pomalidomide, dexamethasone, and daratumumab at indicated doses and schedule every 28 days. Patients may continue to receive treatment in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose (MTD) of carfilzomib when administered in combination with pomalidomide and dexamethasone [ Time Frame: 28 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-1470-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Wayne State University - Karmonos Cancer CenterDetroitMichigan48201-
Sarah Cannon Research InstituteNashvilleTennessee37203-

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