UARK 2009-32 Compassionate Use Study of Carfilzomib

• Status: No longer available
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Collaborator: Onyx Therapeutics, Inc.

Criteria

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