Dara-BCD for Rare MGRS
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPeking University People's Hospital
About this trial
This is an open-label, multicenter, phase 2 study in subjects with newly diagnosed proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMIDs), OR light chain proximal tubulopathy (LCPT), OR thrombotic Microangiopathy (TMA), OR cryoglobulinemic glomerulonephritis, (CGGN), treated with daratumumab, bortezomib, cyclophosphamide, and dexamethasone.
Eligibility criteria
Qualifiers
Diagnosis of PGNMIDs, OR LCPT, OR TMA, OR CGGN.
Evidence of clonal plasma cell in bone marrow.
ECOG 0,1,2
Neu≥ 1.0*10^9/L, HGB ≥70g/L, PLT ≥ 50*10^9/L.
Disqualifiers
Prior therapy for MGRS, 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;
Trial design
Treatments tested in this trial
- Dara-CyBorD
Treatment groups
10 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov