UARK 2009-32 Compassionate Use Study of Carfilzomib

Multiple Myeloma Clinical Trial

— 2009-32  

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT00999414
• Other study ID #: 111527
• Status: No longer available
• Phase: N/A
• First received: October 20, 2009
• Last updated: October 23, 2015
• Start date: November 2009
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

N/A

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	Onyx Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

External Links

•   MIRT Clinical Trials