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Dara-BCD for Rare MGRS

ConditionMonoclonal Gammopathy of Renal Significance (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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Dara-CyBorD

    Drug

    Dara-CyBorD will be used for newly diagnosed PGNMID, OR LCPT, OR TMA OR CGGN.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Dara-CyBorDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of Hematologic Complete Response at the completion of 6 cycles

Hematologic complete response requires absence of monoclonal protein by immunofixation electrophoreses of both serum and urine as well as a normal FLC ratio (FLCr). CR is considered when FLCr was altered in favour of the non-amyloidogenic, uninvolved FLC (uFLC), even though the ratio may not have been normalised.

Time frame
6 months

Secondary outcomes

1

Rate of Hematologic CR (Complete Response)+ VGPR (very good partial response) at the completion of 6 cyels

Time frame
6 months
2

Rate of Hematologic ORR (Overall Response, CR+VGPR+low-dFLC response+PR) at the completion of 6 cyels

Time frame
6 months
3

Renal response at 6 months

Time frame
6 months
4

MRD status at 6 months

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: