UARK 2009-32 Compassionate Use Study of Carfilzomib

NCT ID: NCT00999414

Last Updated: 2015-10-26

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS
• Study Start Date: 2009-11-30
• Study Completion Date: 2015-04-30

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.

Conditions

Multiple Myeloma

Interventions

Carfilzomib

Carfilzomib (20mg/m2) IV push to be given at maximum rate of 10ml/minute on Days 1 and Day 2 of Cycle 1 only.

Carfilzomib (27mg/m2) IV bolus to be given at maximum rate of 10ml/minute on Day 8, 9, 15, and 16 of Cycle 1, then through Cycle 2 and beyond if initial dosing with 20mg/m2 tolerated.

For patients who tolerated 27mg/m2 through cycle 2 Days 1 and 2, Carfilzomib dose may be escalated to 36mg/m2 on days 8, 9, 15 and 16 of cycle 2. If tolerated, subsequent cycles will utilize 36mg/m2.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Onyx Therapeutics, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bart Barlogie, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Related Links

http://www.myeloma.uams.edu/

MIRT Clinical Trials

Other Identifiers

111527

Identifier Type: -

Identifier Source: org_study_id