Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06418477

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

Led by Peking University People's Hospital · Updated on 2024-10-01

20

Participants Needed

3

Research Sites

132 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of monoclonal immunoglobulin deposition disease without prior anti-plasma cell treatment
  • ECOG performance status of 0, 1, or 2
  • Absolute neutrophil count (Neu) at least 1.0 x 10^9/L, hemoglobin (HGB) at least 70 g/L, and platelets (PLT) at least 50 x 10^9/L
  • Total bilirubin at most 3 times the upper limit of normal; AST and ALT at most 3 times the upper limit of normal
  • Patient has been informed about the study, understands it, and has signed informed consent
Not Eligible

You will not qualify if you...

  • Prior therapy for MIDD except dexamethasone at doses of 160 mg or less
  • Diagnosis of active multiple myeloma or active lymphoplasmacytic lymphoma
  • Presence of advanced malignant tumors with systemic metastasis
  • Severe or persistent infections that cannot be controlled
  • Severe autoimmune diseases or immunodeficiency diseases
  • Active hepatitis B or C infection (HBVDNA+ or HCVRNA+)
  • Infection with HIV or syphilis
  • Any condition that increases risk or may affect study results as judged by researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100005

Actively Recruiting

2

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

3

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510062

Actively Recruiting

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Research Team

J

Jin Lu

CONTACT

Y

Yang Liu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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