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 (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05561049

Collaborator

(none)

120

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Newly Diagnosed Multiple Myeloma	Drug: Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma With Renal Dysfunction in Real-World: A Non-interventional Prospective Multicenter Observational Study

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Sep 30, 2025

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

newly diagnosed multiple myeloma;
age over 18 years, male or female;
glomerular filtration rate (eGFR) < 40 mL/min
Patients must have the ability to understand and voluntarily sign the informed consent form, which must be signed before any trial process;
patients who completed at least one course of treatment were included in the safety observation;
Patients who completed at least 2 courses of treatment were included in the efficacy observation;

Exclusion Criteria:

acute and chronic renal insufficiency not caused by myeloma;
are receiving any other investigational drug or investigational medical device;
Patients with other cancers confirmed before MM diagnosis, except cervical carcinoma in situ or scaly cell carcinoma of the skin and basal cell carcinoma that are considered cured for more than 3 years before enrollment;
patients who do not complete a course of DVTd treatment for any reason, unless permanent discontinuation or death due to the drug;