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| Name | Class |
|---|---|
| Onyx Therapeutics, Inc. | INDUSTRY |
This is a compassionate use, open-label, IND study for the purpose of providing carfilzomib to patients with relapsed or resistant refractory multiple myeloma.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carfilzomib | Drug | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bart Barlogie, MD, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| Label | URL |
|---|---|
| MIRT Clinical Trials | View source |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C524865 | carfilzomib |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |