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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05561049

Enrollment

120

Registered

2022-09-30

Start date

2022-10-01

Completion date

2025-09-30

Last updated

2022-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly Diagnosed Multiple Myeloma

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.

Interventions

DRUGDaratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens

Daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone Regimens

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame
Very good partial response (VGPR) rate	28 days after consolidation therapy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026