An Open-Label Study to Determine the Maximum Tolerated Dose and Evaluate the Efficacy and Safety of CEP-18770 in Patients With Relapsed Multiple Myeloma Refractory to the Most Recent Therapy
The primary objective for part 1 of the study is to determine the maximum tolerated dose (MTD) of CEP-18770 in patients with relapsed and refractory multiple myeloma. The primary objective for part 2 is to evaluate the antitumor activity of CEP-18770 in patients treated at the MTD.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : CEP-18770
Phase: Phase 1/Phase 2
Ages Eligible For Study:
The patient has: - relapsed multiple myeloma that has progressed following therapies that included bortezomib and an IMiD (thalidomide or lenalidomide) either alone or in any combination. - multiple myeloma, which is refractory to the most recent therapy (bortezomib or IMiD, or any other chemotherapy), or the patient did not tolerate and discontinued the most recent therapy for multiple myeloma but has recovered from its toxic effects. - measurable disease defined as 1 of the following: - serum M-protein ?0.5 g/dL - urine M-protein ?200 mg/24 hours - a life expectancy of more than 3 months. - an ECOG performance status of 0, 1, or 2. - adequate hepatic organ function. - an absolute neutrophil count (ANC), hemoglobin level, and platelet count within protocol-specific ranges. - been independent of granulocyte-colony stimulating factor (G-CSF) or granulocyte macrophage-colony stimulating factor (GM-CSF) support for more than 1 week. - been independent of platelet transfusion for more than 1 week. - received, or may have received, an allogeneic and/or autologous transplant. - a creatinine clearance of 30 mL/minute or more as measured or as calculated based on the Cockcroft-Gault method. - if the patient is a female of childbearing potential (not surgically sterile or 1 year postmenopausal): must use a medically accepted method of contraception (including abstinence) and must agree to continue use of this method for the duration of the study and for 3 months after participation in the study. - if the patient is a male: is surgically sterile, or if sexually active, is currently using an effective barrier method of contraception, and agrees to continue use of this method for the duration of the study and for 3 months after the last administration of study drug. Key