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Combination of Daratumumab and BD Regimen and Dapagliflozin in the Treatment of M-protein Related Cardiac Disease

NCT06297681 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2024-03-07

No results posted yet for this study

Summary

It is expected to include 40 patients with M-protein related cardiac disease. The treatment medication for enrolled patients must comply with the treatment regimen of Daratumumab + Bortezomib + Dexamethasone. All patients were given Dapagliflozin 10mg/day at the beginning of treatment (creatinine clearance rate greater than 20ml/min).

Conditions

  • M-protein Related Cardiac Disease

Interventions

DRUG

Daratumumab + Bortezomib + Dexamethasone + Dapagliflozin

The treatment medication for enrolled patients must comply with the treatment regimen of Daratumumab + Bortezomib + Dexamethasone: subcutaneous injection of 1800mg of Daratumumab, d1, 8,15,22 (28 day cycle); (After 2 cycles of improvement in cardiac indicators, it can be adjusted to intravenous injection of daratumumab); Bortezomib 1.3 mg/m2 d1, 8, 15, 22; D1, 8, 15, 22; Dexamethasone 20 mg d1, 2, 8, 9, 15, 16, 22, 23. When NTProBNP is greater than 5400ng/ml, bortezomib 1.0mg/m2; When NTProBNP is greater than 8500ng/ml, bortezomib is 0.7mg/m2. When NTProBNP is greater than 10000ng/ml, bortezomib is temporarily not allowed; NTProBNP greater than 4500ng/ml dexamethasone starts at 10 mg/dose. All patients were given Dapagliflozin 10mg/day at the beginning of treatment (creatinine clearance rate greater than 20ml/min).

Sponsors & Collaborators

  • Beijing Chuiyangliu Hospital

    collaborator OTHER_GOV

  • Beijing Boren Hospital

    collaborator OTHER

  • Beijing Chao Yang Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2025-01-30
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06297681 on ClinicalTrials.gov