drugset / Trial / NCT04096066
A Trial That Compare Two Treatments in Newly Diagnosed Myeloma Patients Not Eligible for Transplant
RandomizedParallel-groupOpen-labelTreatment
Summary
The combination of lenalidomide plus low-dose dexamethasone (Rd) is considered the new standard for elderly newly diagnosed multiple myeloma (NDMM) patients. The combination carfilzomib plus lenalidomide-dexamethasone (KRd) in relapsed-refractory MM patients improved the progression-free survival (PFS) of approximately 1 year compared to standard Rd treatment. In a small phase 2 trial (23 pts) the KRd combination in elderly NDMM pts showed a complete response (CR) rate of 79% and a PFS at 3 years of 80%. Cardiovascular adverse events are the most limiting toxicities, especially in elderly patients.
Timeline
- Start
- 2019-07-01
- Primary completion
- 2026-01-01
- Completion
- 2026-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carfilzomib | Other / unclassified | 56 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |
| Background | Lenalidomide | Other / unclassified | 25 mg | Oral |