Compassionate Use Study of Carfilzomib (2009-32)
This study is currently recruiting participants.
Verified December 2012 by University of Arkansas
Sponsor:
University of Arkansas
Collaborator:
Onyx Therapeutics, Inc.
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00999414
First received: October 20, 2009
Last updated: December 19, 2012
Last verified: December 2012
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Purpose
This is a compassionate use, open-label, IND study for the purpose of providing carfilzomib to patients with relapsed or resistant refractory multiple myeloma.
| Condition | Intervention |
|---|---|
|
Multiple Myeloma |
Drug: Carfilzomib |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Compassionate Use Study of Carfilzomib for Patients With Relapsing or Resistant Multiple Myeloma |
Resource links provided by NLM:
MedlinePlus related topics:
Multiple Myeloma
Drug Information available for:
Carfilzomib
U.S. FDA Resources
Further study details as provided by University of Arkansas:
Primary Outcome Measures:
- prevent CMV [ Time Frame: 19 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 140 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Carfilzomib |
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. |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999414
Contacts
| Contact: Nathan Petty | 501-526-6990 ext 2435 | pettynathanm@uams.edu |
| Contact: Susan Panozzo | 501-526-6990 ext 2457 | panozzosusanb@uams.edu |
Locations
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Nathan Petty 501-526-6990 ext 2435 pettynathanm@uams.edu | |
| Principal Investigator: Bart Barlogie, MD, PhD | |
| Sub-Investigator: Monica Grazziutti, MD | |
| Sub-Investigator: Frits van Rhee, MD, PhD | |
| Sub-Investigator: Sarah Waheed, MD | |
| Sub-Investigator: Saad Usmani, MD | |
| Sub-Investigator: Alejandro Restrepo, MD | |
| Sub-Investigator: Sajjad Haider, MD | |
| Sub-Investigator: Zainab Shahid, MD | |
| Sub-Investigator: Al-Ola Abdallah, MD | |
| Sub-Investigator: Jameel Muzaffar, MD | |
| Sub-Investigator: Nisar Ahmad, MD | |
| Sub-Investigator: Senu Apewokin, MD | |
| Sub-Investigator: Shebli Atrash, MD | |
| Sub-Investigator: Aziz Bakhous, MD | |
| Sub-Investigator: Surachit Kumar, MD | |
Sponsors and Collaborators
University of Arkansas
Onyx Therapeutics, Inc.
Investigators
| Principal Investigator: | Bart Barlogie, MD, PhD | University of Arkansas |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT00999414 History of Changes |
| Other Study ID Numbers: | UARK 2009-32 |
| Study First Received: | October 20, 2009 |
| Last Updated: | December 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Arkansas:
|
MM |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013