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Trial Title:
Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma
NCT ID:
NCT05561049
Condition:
Newly Diagnosed Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Thalidomide
Dexamethasone
Bortezomib
Daratumumab
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens
Description:
Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens
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.
Criteria for eligibility:
Study pop:
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;
Sampling method:
Non-Probability Sample
Criteria:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 1, 2022
Completion date:
September 30, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05561049
