Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT05561049
Status
Unknown

Conditions

  • Newly Diagnosed Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is an observational, multi-center, non-interventional study, which is designed to evaluate the safety and efficacy of daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone (D-VTD) Regimens in NDMM patients with renal dysfunction in real-world clinical practice. The data collected in this trial are for subjects with NDMM and renal dysfunction treated with D-VTd regimen and consist of 2 treatment phases, efficacy and safety data from induction phase and consolidation phase.

Key Dates

Start date
Oct 1, 2022
Status verified
Sep 2022
Primary completion
Sep 30, 2024
Completion
Sep 30, 2025

Study Design

Enrollment
120 participants (estimated)

Primary Outcome Measure

Very good partial response (VGPR) rate [ Time Frame: 28 days after consolidation therapy ]

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