Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with MIDD
Recruiting now · Phase 2
Conditions studied: Monoclonal Gammopathy of Renal Significance
In brief
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.
Key facts
- Study ID
- NCT06418477
- Run by
- Peking University People's Hospital
- People needed
- 20
- Starts
- 2024-06-15
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2024-10-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Prior therapy for MIDD, with the exception of equal or less than 160 mg dexamethasone (or equivalent corticosteroid)
- Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
- Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
- Severe or persistent infection that cannot be effectively controlled;
- Presence of severe autoimmune diseases or immunodeficiency disease;
- Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]);
- Patients with HIV infection or syphilis infection;
- Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Where it is running
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)
- Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)
- The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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