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Compassionate Use Study of Carfilzomib for Patients With Relapsing or Resistant Multiple Myeloma

18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

Compassionate Use Study of Carfilzomib for Patients With Relapsing or Resistant Multiple Myeloma

The protocol has been designed for relapsing or refractory multiple myeloma patients. A
maximum of 30 patients may be treated on this protocol.

Since this is a compassionate use study of an investigational agent, the size is determined
by agreement with the manufacturer of carfilzomib. Therefore, the time period for enrollment
and accrual number will be limited to N=30.

Inclusion Criteria:

- Participants must have histologically documented multiple myeloma which is relapsing
or resistant after stem cell transplantation, or when other conventional therapies
have failed or are contraindicated

- Serum creatinine < 3.0 mg/dL OR calculated creatinine clearance >15 mL/min calculated
or measured clearance is ≥15 mL/min

- ANC > 1000/mm3 (may be supported with growth factors)

- Platelet count > 30,000/mm3 (may receive transfusion)

- Female participant of child-bearing potential has agreed to use dual methods of
contraception for the duration of the study

- Male participant has agreed to use a barrier method of contraception if sexually
active with a female of child-bearing potential

- Patients must have signed and IRB-approved written informed consent form and
demonstrate willingness to meet follow-up schedule and study procedure obligations

Exclusion Criteria:

- Active infection requiring systemic treatment

- Requires concomitant use of approved or investigative anticancer therapeutic
treatment with activity against multiple myeloma, other than dexamethasone

- Concomitant use of other investigative agents (e.g., antibiotics or antiemetics)

- Pregnant or breast-feeding

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

prevent CMV

Outcome Time Frame:

19 weeks

Safety Issue:


Principal Investigator

Bart Barlogie, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas


United States: Food and Drug Administration

Study ID:

UARK 2009-32



Start Date:

November 2009

Completion Date:

December 2013

Related Keywords:

  • Multiple Myeloma
  • MM
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205