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PVd Versus Vd in NDMM Patients With RI

NCT05432414 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2023-01-31

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Peking University People's Hospital

    collaborator OTHER

  • Shanghai Changzheng Hospital

    collaborator OTHER

  • Shanghai 6th People's Hospital

    collaborator OTHER

  • Peking University Shenzhen Hospital

    collaborator OTHER

  • The Third People's Hospital of Chengdu

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • Ningbo No. 1 Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Nanchang University

    collaborator OTHER

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Jian Hou, PhD · RenJi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-08
Primary Completion
2023-12-31
Completion
2024-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05432414 on ClinicalTrials.gov