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

NCT05561049 | Unknown FDA Drug

• 1 other identifier: D-VTD-MM07
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Newly Diagnosed Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Very good partial response (VGPR) rate

  28 days after consolidation therapy

Interventions

Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens DRUG

Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. newly diagnosed MM; 2. age over 18 years, male or female; 3. glomerular filtration rate (eGFR) \< 40 mL/min 4. patients who completed at least one course of treatment were included in the safety observation; 5. Patients who completed at least 2 courses of treatment were included in the efficacy observation;

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

MeSH Terms

Interventions

daratumumab; Bortezomib; Thalidomide

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: October 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2025
• Last Updated: September 30, 2022

Record last verified: 2022-09