Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297681
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-03-01
Brief Title:
Combination of Daratumumab and BD Regimen and Dapagliflozin in the Treatment of M-protein Related Cardiac Disease
Sponsor:
Beijing Chao Yang Hospital
Organization:
Beijing Chao Yang Hospital
Study Overview
Official Title:
A Cross-sectional Study on the Efficacy and Safety of the Combination of DaratumumabBortezomibDexamethasone Regimen and Dapagliflozin in the Treatment of M-protein Related Cardiac Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 10mgday at the beginning of treatment creatinine clearance rate greater than 20mlmin
Detailed Description:
This study is a multicenter single arm observational clinical studyIt is expected to include 40 patients with M-protein related cardiac disease who will sign informed consent forms Collect baseline examination treatment period planned 6 cycles and follow-up period survival follow-up data for patients who meet the inclusion and exclusion criteria The treatment medication for enrolled patients must comply with the treatment regimen of Daratumumab Bortezomib Dexamethasone subcutaneous injection of 1800mg of Daratumumab d1 81522 28 day cycle After 2 cycles of improvement in cardiac indicators it can be adjusted to intravenous injection of daratumumab Bortezomib 13 mgm2 d1 8 15 22 D1 8 15 22 Dexamethasone 20 mg d1 2 8 9 15 16 22 23 When NTProBNP is greater than 5400ngml bortezomib 10mgm2 When NTProBNP is greater than 8500ngml bortezomib is 07mgm2 When NTProBNP is greater than 10000ngml bortezomib is temporarily not allowed NTProBNP greater than 4500ngml dexamethasone starts at 10 mgdose All patients were given Dapagliflozin 10mgday at the beginning of treatment creatinine clearance rate greater than 20mlmin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None