Status and phase
Conditions
Treatments
About
To evaluate the overall response rate and safety and tolerability of carfilzomib in subjects with relapsed and refractory multiple myeloma.
Patients must have received prior treatment with bortezomib and either thalidomide or lenalidomide and be refractory to their last treatment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Disease Related
Multiple myeloma
Subjects must have measurable disease defined as one of the following:
Subjects must have been responsive (i.e., achieved an MR or better) to first-line, standard of care therapy
Refractory to the most recently received therapy. Refractory disease is defined as ≤ 25% response or progression during therapy or within 60 days after completion of therapy.
Subjects must have received ≥ 2 prior regimens for relapsed disease. Induction therapy and stem cell transplant will be considered as one regimen (A1 Only)
Subjects must have received prior treatment with bortezomib, and either thalidomide or lenalidomide
Subjects must have received an alkylating agent either alone or in combination with other myeloma treatments (history of stem cell transplant is acceptable) (A1 Only)
Subjects must have received an anthracycline either alone or in combination with other myeloma treatments, unless not clinically indicated (A1 Only)
Demographic
Laboratory
Adequate hepatic function, with bilirubin less than 2.0 times the upper limit of normal, and AST and ALT of less than 3.0 times the upper limit of normal
Uric acid within normal range (A0 Only)
Total white blood cell (WBC) count ≥ 2.0 × 109/L, absolute neutrophil count (ANC) ≥ 1.0 × 109/L, hemoglobin ≥ 8.0 g/dL, and platelet count ≥ 50.0 × 109/L (A0 Only)
Absolute neutrophil count > 1,000/mm3, hemoglobin > 8.0 g/dL, and platelet count > 50,000/mm3 (A1 Only)
Calculated and measured creatinine clearance of ≥ 30 mL/minute, calculated using the formula of Cockcroft and Gault [(140 - Age) X Mass (kg) / (72 X Creatinine mg/dL)]. Multiply result by 0.85 if female.
Ethical / Other
Exclusion criteria
Disease Related
Concurrent Conditions
Ethical / Other
Primary purpose
Allocation
Interventional model
Masking
312 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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