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| Sponsor: | Proteolix |
|---|---|
| Information provided by: | Proteolix |
| ClinicalTrials.gov Identifier: | NCT00511238 |
Purpose
250 evaluable subjects with relapsed and refractory multiple myeloma will be enrolled to evaluate the overall response rate and safety and tolerability of carfilzomib in this phase 2 study. Patients must have received prior treatment with bortezomib and either thalidomide or lenalidomide and be refractory to their last treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: carfilzomib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Open-label, Single-arm, Phase 2 Study of Carfilzomib in Patients With Relapsed and Refractory Multiple Myeloma |
| Estimated Enrollment: | 250 |
| Study Start Date: | August 2007 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Disease Related
Subjects must have measurable disease defined as one of the following:
Demographic
Laboratory
Ethical / Other
Exclusion Criteria:
Disease Related
Concurrent Conditions
Ethical / Other
Contacts and Locations
Show 34 Study Locations
More Information
| Responsible Party: | Proteolix Inc ( Michael Kauffman, MD,PhD ) |
| Study ID Numbers: | PX-171-003 |
| Study First Received: | August 1, 2007 |
| Last Updated: | October 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00511238 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Proteolix PR171 carfilzomib |
multiple myeloma relapsed refractory |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |