Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with MIDD

Last updated: September 29, 2024
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Dara-CyBorD

Clinical Study ID

NCT06418477
2024PHB134-001
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of monoclonal immunoglobulin deposition disease without anti-plasma celltreatment

  2. ECOG 0,1,2

  3. Neu≥ 1.010^9/L, HGB ≥70g/L, PLT ≥ 5010^9/L.

  4. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;

  5. Informed consent explained to, understood by and signed by the patient.

Exclusion

Exclusion Criteria:

  1. Prior therapy for MIDD, with the exception of equal or less than 160 mgdexamethasone (or equivalent corticosteroid)

  2. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacyticlymphoma.

  3. Presence of other tumors which is/are in advanced malignant stage and has/havesystemic metastasis;

  4. Severe or persistent infection that cannot be effectively controlled;

  5. Presence of severe autoimmune diseases or immunodeficiency disease;

  6. Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]);

  7. Patients with HIV infection or syphilis infection;

  8. Any situations that the researchers believe will increase the risks for the subjector affect the results of the study.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Dara-CyBorD
Phase: 2
Study Start date:
June 15, 2024
Estimated Completion Date:
December 31, 2026

Study Description

The current study aims to investigate daratumumab, bortezomib, cyclophosphamide, and dexamethasone regimen in patients with newly diagnosed monoclonal immunoglobulin deposition disease. Approximately 25 subjects will receive primary therapy with daratumumab-CyBorD. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months.

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100005
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510062
    China

    Active - Recruiting

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