drugset / Trial / NCT06409702
Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection
NaSingle-groupOpen-labelTreatment
Summary
The goal of this study is to evaluate sustained MRD negativity for one year in DKRD induction \& consolidation therapy +/- ASCT in newly diagnosed high-risk multiple myeloma patients. It aims to evaluate the efficacy and safety of the combination regimen of Daratumumab in combination with carfilzomib, lenalidomide, and dexamethasone (DKRD) +/- ASCT for the treatment of patients with newly diagnosed high-risk multiple myeloma. Participants will receive bortezomib based induction therapy for one cycle, and then DKRD induction for 3 cycles(+ASCT), DKRD consolidation for 2-4 cycles, and DKR maintenance treatment(adjusted according to MRD negativity after consolidation therapy)
Timeline
- Start
- 2024-06-12
- Primary completion
- 2027-11-30
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | — |
| Subject | Carfilzomib | Other / unclassified | 20 mg/m2 | — |
| Subject | Carfilzomib | Other / unclassified | 36 mg/m2 | — |
| Subject | Carfilzomib | Other / unclassified | 56 mg/m2 | — |
| Subject | Carfilzomib | Other / unclassified | 70 mg/m2 | — |
| Subject | Daratumumab | Monoclonal antibody | 16 mg/kg | — |
| Subject | Dexamethasone | Small molecule | 20 mg | Oral |
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 10 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |