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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Newly Diagnosed Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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D-VTD-MM07

Identifier Type: -

Identifier Source: org_study_id