UARK 2009-32 Compassionate Use Study of Carfilzomib
2009-32
Compassionate Use Study of Carfilzomib for Patients With Relapsing or Resistant Multiple Myeloma
1 other identifier
expanded_access
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2009
CompletedFirst Posted
Study publicly available on registry
October 21, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedOctober 26, 2015
October 1, 2015
5.4 years
October 20, 2009
October 23, 2015
Conditions
Keywords
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Arkansaslead
- Onyx Therapeutics, Inc.collaborator
Study Sites (1)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bart Barlogie, MD, PhD
University of Arkansas
Study Design
- Study Type
- expanded access
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2009
First Posted
October 21, 2009
Study Start
November 1, 2009
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
October 26, 2015
Record last verified: 2015-10