Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with Monoclonal Immunoglobulin Deposition Disease
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosis of monoclonal immunoglobulin deposition disease without anti-plasma cell treatment
• ECOG 0,1,2
• Neu≥ 1.0\*10\^9/L, HGB ≥70g/L, PLT ≥ 50\*10\^9/L.
• Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
• Informed consent explained to, understood by and signed by the patient.
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
The First Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Jin Lu
jin1lu@sina.com
86-13311491805
Backup
Yang Liu
pkuphliuyang@bjmu.edu.cn
86-13716926210
Time Frame
Start Date: 2024-06-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Dara-CyBorD
Daratumumab:~Cyclophosphamide Bortezomib Dexamethasone
Related Therapeutic Areas
Sponsors
Leads: Peking University People's Hospital