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

Newly Diagnosed Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05561049
• Other study ID #: D-VTD-MM07
• Status: Not yet recruiting
• Start date: October 1, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: September 2022
• Source: The First Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. newly diagnosed multiple myeloma;

2. age over 18 years, male or female;

3. glomerular filtration rate (eGFR) < 40 mL/min

4. Patients must have the ability to understand and voluntarily sign the informed consent form, which must be signed before any trial process;

5. patients who completed at least one course of treatment were included in the safety observation;

6. Patients who completed at least 2 courses of treatment were included in the efficacy observation;

Exclusion Criteria:

1. acute and chronic renal insufficiency not caused by myeloma;

2. are receiving any other investigational drug or investigational medical device;

3. 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;

4. patients who do not complete a course of DVTd treatment for any reason, unless permanent discontinuation or death due to the drug;

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Newly Diagnosed Multiple Myeloma

Intervention

Drug:
• Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens
Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Very good partial response (VGPR) rate		28 days after consolidation therapy