Status: Closed
Activation Date: 2010JUN15
Closing Date: 2012JUL26
Phase: II
Description: A Phase II Study of AT9283 in Patients with Relapsed or Refractory Multiple Myeloma
Eligibility: Patients must have a confirmed diagnosis of multiple myeloma and measurable disease, according to internationally accepted criteria for myeloma. Patients must have received prior treatment for multiple myeloma, and have relapsed or progressed on prior therapy. No more than three prior regimens; prior treatment must be completed at least 4 weeks prior to registration. ECOG performance status must be 0, 1 or 2; adequate hematologic and organ function.
Objective: To assess the efficacy of AT9283 when given as a 24 hour infusion on Days 1 and 8 every three weeks to patients with relapsed or refractory multiple myeloma; to determine the adverse effects of AT9283; to evaluate potential predictive and prognostic biomarkers (marrow, blood); and to evaluate disease-related symptoms including pain, fatigue and mucositis.
Participation: Limited to invited centres
Lay Description: The main purpose of this study is to find out whether the new drug AT9283 will slow the growth of multiple myeloma. A secondary objective is to learn more about the side effects of AT9283.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I191 | 8 | 4 | 0 | 4 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I191 | 8 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I191 | 8 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |