A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma
To compare progression-free survival in subjects with relapsed multiple myeloma who are receiving CRd vs subjects receiving Rd in a randomized multicenter setting.
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 : Dexamethasone
- drug : Carfilzomib
- drug : Lenalidomide
Phase: Phase 3
Ages Eligible For Study:
1. Symptomatic multiple myeloma 2. Measurable disease, as defined by one or more of the following (assessed within 21 days prior to randomization): - Serum M-protein ? 0.5 g/dL - Urine Bence-Jones protein ? 200 mg/24 hours - For IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ? 750 mg/dL (0.75 g/dL) 3. Prior treatment with at least one, but no more than three, regimens for multiple myeloma 4. Documented relapse or progressive disease on or after any regimen 5. Achieved a response to at least one prior regimen 6. Age ? 18 years 7. Life expectancy ? 3 months 8. Eastern Cooperative Oncology Group performance status 0-2 9. Adequate hepatic function, with serum ALT ? 3.5 times the upper limit of normal and serum direct bilirubin ? 2 mg/dL (34 µmol/L) within 21 days prior to randomization 10. Absolute neutrophil count ? 1.0 × 10^9/L within 21 days prior to randomization 11. Hemoglobin ? 8 g/dL (80 g/L) within 21 days prior to randomization 12. Platelet count ? 50 × 10^9/L (? 30 × 10^9/L if myeloma involvement in the bone marrow is > 50%) within 21 days prior to randomization 13. Creatinine clearance (CrCl) ? 50 mL/minute within 21 days prior to randomization 14. Written informed consent in accordance with federal, local, and institutional guidelines 15. Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception 16. Male subjects must agree to practice contraception