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Carfilzomib in Patients with Relapsed and Refractory Multiple Myeloma (PX-171-003)
Newly Expanded Open-label, Single-arm, Phase 2 Study in Patients with Relapsed and Refractory Multiple Myeloma: Carfilzomib given at increasing doses and with dexamethasone.
06.01.09

Open-label, Single-arm, Phase 2 Study in Patients with Relapsed and Refractory Multiple Myeloma
Carfilzomib given at increasing doses and with dexamethasone.

Trial description:
This is a single-arm study for patients who have relapsed following two or more therapies and are refractory to the most recently received therapy. All patients will receive an initial dose of carfilzomib, which will be increased after the first cycle if well tolerated. Patients also receive dexamethasone with each dose of carfilzomib.

Trial objectives:
To evaluate the efficacy and safety of carfilzomib at different doses

Inclusion criteria:

  • 18 years or older
  • Adequate ability to perform acts of daily living
  • Symptomatic myeloma with measurable disease
  • Received 2 or more prior regimens for relapsed disease
  • Refractory to the most recent treatment
  • Previously treated with Velcade and with either thalidomide or Revlimid

Exclusion Criteria:

  • Non-secretory myeloma and disease measurable only by serum free light chain (SFLC) analysis
  • Patients who were not responsive to standard first-line therapy
  • Systemic myeloma treatment within 3 weeks of study, radiation or immunotherapy within previous 4 weeks of study or local radiation therapy within one week of study.
  • Significant neuropathy (Grade 3, 4 or Grade 2 with pain)
  • Acute active infection requiring systemic antibiotics, antivirals or antifungals with 2 weeks of study

Locations and Trial Coordinator Telephone Contacts:

USA

  • Mayo Clinic
    Scottsdale, AZ
    480-301-4890

  • Tower Cancer Research Foundation
    Beverly Hills, CA
    310-285-7269

  • City of Hope
    Duarte, CA
    626-256-4673, X 65282

  • Scripps Cancer Center
    La Jolla, CA
    858-652-5538

  • UCSF
    San Francisco, CA
    415-502-3176

  • Moffitt Cancer Center
    Tampa, FL
    813-745-5758

  • Emory University
    Atlanta, GA
    404-778-5747

  • Northwestern University
    Chicago, IL
    312-695-1383

  • Rush University Medical Center,
    Chicago, IL:
    312-942-3327

  • University of Kentucky,
    Lexington, KY
    859-257-4465

  • University of Michigan,
    Ann Arbor, MI
    734-936-2740

  • Karmanos Cancer Institute,
    Detroit, MI
    313-576-8673

  • Mayo Clinic
    Rochester, MN
    507-538-7623

  • Washington University School of Medicine
    St. Louis, MO
    314-454-8377

  • Hackensack University Medical Center,
    Hackensack, NJ
    210-336-8020

  • Roswell Park Cancer Institute,
    Buffalo, NY
    716-845-2912

  • St. Vincent Catholic Medical Center
    New York NY: 
    212-367-0195

  • Wake  Forest University,
    Winston-Salem, NC:
    336-713-6915

  •  Gabrail Cancer Center
    Canton, OH
    330-492-3345, X 208


  • Cleveland Clinic,
    Cleveland, Ohio
    216-445-6235


  • University of Pennsylvania
    Philadelphia, PA
    215-662-2716

  • Sarah Cannon Research Institute
    Nashville, TN
    615-329-723

  • MD Anderson Cancer Center
    Houston, TX
    713-792-9559

CANADA

  • University of Calgary Health Sciences Centre,
    Calgary, Alberta
    403-521-3452

  • Cross Cancer Institute,
    Edmonton, Alberta
    780-432-8261

  • Princess Margaret Hospital,
    Toronto, Ontario
    416-946-4501, X5931

  • Leukemia/BMT Program of BC
    Vancouver, British Columbia
    604-875-4111, X 62887


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