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Brief Title: Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients With MIDD
Official Title: Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients With Monoclonal Immunoglobulin Deposition Disease
Study ID: NCT06418477
Brief Summary: This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed monoclonal immunoglobulin deposition disease treated with daratumumab, bortezomib, cyclophosphamide, and dexamethasone.
Detailed Description: The current study aims to investigate daratumumab, bortezomib, cyclophosphamide, and dexamethasone regimen in patients with newly diagnosed monoclonal immunoglobulin deposition disease. Approximately 25 subjects will receive primary therapy with daratumumab-CyBorD. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Peking Union Medical College Hospital, Beijing, Beijing, China
Peking University People's Hospital, Beijing, Beijing, China
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Name: Jin Lu
Affiliation: Peking University People's Hospital
Role: PRINCIPAL_INVESTIGATOR