Actively Recruiting
Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with MIDD
Led by Peking University People's Hospital · Updated on 2024-10-01
20
Participants Needed
3
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with MIDD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of monoclonal immunoglobulin deposition disease without prior anti-plasma cell treatment
- ECOG performance status of 0, 1, or 2
- Absolute neutrophil count (Neu) at least 1.0 x 10^9/L, hemoglobin (HGB) at least 70 g/L, and platelets (PLT) at least 50 x 10^9/L
- Total bilirubin at most 3 times the upper limit of normal; AST and ALT at most 3 times the upper limit of normal
- Patient has been informed about the study, understands it, and has signed informed consent
You will not qualify if you...
- Prior therapy for MIDD except dexamethasone at doses of 160 mg or less
- Diagnosis of active multiple myeloma or active lymphoplasmacytic lymphoma
- Presence of advanced malignant tumors with systemic metastasis
- Severe or persistent infections that cannot be controlled
- Severe autoimmune diseases or immunodeficiency diseases
- Active hepatitis B or C infection (HBVDNA+ or HCVRNA+)
- Infection with HIV or syphilis
- Any condition that increases risk or may affect study results as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
Actively Recruiting
2
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
3
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510062
Actively Recruiting
Research Team
J
Jin Lu
CONTACT
Y
Yang Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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