drugset / Trial / NCT04025450
Comparation of Chidamide Plus VRD (Bortezomib, Lenalidomide, Dexamethasone) With VRD Regimen for Primary High-Risk Multiple Myeloma Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
In the phase I trial, dose escalation of chidamide will be performed at 4 different dosages (15mg, 20mg, 25mg, 30mg) for optimal dosage, in the phase II trial, the safety and efficacy of chidamide+VRD will be compared with that of VRD regimen.
Timeline
- Start
- 2019-07-15
- Primary completion
- 2029-07-15
- Completion
- 2029-07-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tucidinostat | Small molecule | 15 mg | — |
| Subject | Tucidinostat | Small molecule | 20 mg | — |
| Subject | Tucidinostat | Small molecule | 25 mg | — |
| Subject | Tucidinostat | Small molecule | 30 mg | — |
| Background | Bortezomib | Small molecule | 1.3 mg/m2 | — |
| Background | Dexamethasone | Small molecule | 10 mg | — |
| Background | Lenalidomide | Other / unclassified | 25 mg | — |