Status:
NO_LONGER_AVAILABLE
UARK 2009-32 Compassionate Use Study of Carfilzomib
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
Onyx Therapeutics, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Brief Summary
This is a compassionate use, open-label, IND study for the purpose of providing carfilzomib to patients with relapsed or resistant refractory multiple myeloma.
Detailed Description
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 investiga...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
EXPANDED_ACCESS
End Date :
April 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00999414
Start Date
November 1 2009
End Date
April 1 2015
Last Update
October 26 2015
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205