UARK 2009-32 Compassionate Use Study of Carfilzomib

• Conditions: Multiple Myeloma

• Registration Number: NCT00999414
• Lead Sponsor: University of Arkansas

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 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.

Study Timeline

• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-20
• Study First Posted: 2009-10-21
• Study Start: 2009-11
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-23
• Last Update Posted: 2015-10-26

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States