drugset / Trial / NCT05432414
PVd Versus Vd in NDMM Patients With RI
Phase 2
Unknown
79 enrolled
RenJi Hospital
Ningbo No. 1 Hospital · collabPeking University People's Hospital · collabPeking University Shenzhen Hospital · collabShanghai 6th People's Hospital · collabShanghai Changzheng Hospital · collabThe First Affiliated Hospital of Nanchang University · collabThe First Affiliated Hospital with Nanjing Medical University · collabThe Third People's Hospital of Chengdu · collabXinhua Hospital, Shanghai Jiao Tong University School of Medicine · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, randomized controlled, open-label study, and the purpose of this study is to compare the efficiency and safety of PVD regimen (Pomalidomide \& Bortezomib \& Dexamethasone) versus VD regimen (Bortezomib \& Dexamethasone) in NDMM patients with RI. The main efficacy indicator is VGPR after 4 cycles of induction therapy.
Timeline
- Start
- 2022-12-08
- Primary completion
- 2023-12-31
- Completion
- 2024-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 20 mg | Oral |
| Subject | Pomalidomide | Other / unclassified | 4 mg | Oral |