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NCT Number: NCT06771180

Dara-BCD for Rare MGRS

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

The current study aims to investigate daratumumab, bortezomib, cyclophosphamide, and dexamethasone regimen in patients with newly diagnosed PGNMIDs, LCPT, TMA, CGGN. Approximately 10 subjects will receive primary therapy with daratumumab-CyBorD. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

Dara-CyBorD

Drug

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

Primary outcomes

  1. Rate of Hematologic Complete Response at the completion of 6 cycles

    Time frame: 6 months

    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.

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

  5. Renal Survival in 2 years

    Time frame: 2 years

  6. Overall Survival in 2 years

    Time frame: 2 years

  7. TRAEs

    Time frame: 2 years

    Treatment-related adverse events up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with Rare Monoclonal Gammopathies of Renal Significance

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 13, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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