UARK 2009-32 Compassionate Use Study of Carfilzomib

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

This is a compassionate use, open-label, IND study for the purpose of providing carfilzomib to patients with relapsed or resistant refractory 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