UARK 2009-32 Compassionate Use Study of Carfilzomib (2009-32)
Primary Purpose
Multiple Myeloma
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Carfilzomib
Sponsored by
About this trial
This is an expanded access trial for Multiple Myeloma focused on measuring MM
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
Sites / Locations
- University of Arkansas for Medical Sciences
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00999414
First Posted
October 20, 2009
Last Updated
October 23, 2015
Sponsor
University of Arkansas
Collaborators
Onyx Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00999414
Brief Title
UARK 2009-32 Compassionate Use Study of Carfilzomib
Acronym
2009-32
Official Title
Compassionate Use Study of Carfilzomib for Patients With Relapsing or Resistant Multiple Myeloma
Study Type
Expanded Access
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
No longer available
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
Onyx Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
MM
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart Barlogie, MD, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.myeloma.uams.edu/
Description
MIRT Clinical Trials
Learn more about this trial
UARK 2009-32 Compassionate Use Study of Carfilzomib
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