NCT05432414

PVd Versus Vd in NDMM Patients With RI

Pomalidomide, Bortezomib and Dexamethasone (PVd) Versus Bortezomib and Dexamethasone (Vd) in NDMM Patients With Renal Injury (RI)：A Multicenter, Randomized Controlled, Open-label Trial.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	pomalidomide	Pomalidomide was administered orally at a dose of 4 mg on days 1-14 of each cycle.
DRUG	Bortezomib	Bortezomib was administered intravenously or subcutaneously at a dose of 1.3mg/m2 on days 1, 4, 8, 11 of each cycle.
DRUG	Dexamethasone	Dexamethasone was administered orally at a dose of 20mg on days the same and next day of bortezomib administration.

Timeline

• Start date: 2022-12-08
• Primary completion: 2023-12-31
• Completion: 2024-07-31
• First posted: 2022-06-27
• Last updated: 2023-01-31

Locations

1 site across 1 country: China