Treatment for newly diagnosed monoclonal immunoglobulin deposition disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter Phase 2 study investigates the efficacy of a treatment regimen consisting of daratumumab, bortezomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed monoclonal immunoglobulin deposition disease. Approximately 25 subjects will be enrolled to receive this combination therapy, with the primary endpoint being the overall complete hematologic response rate assessed at 6 months. The study aims to provide insights into the effectiveness of this treatment approach for this specific condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of monoclonal immunoglobulin deposition disease without anti-plasma cell treatment
2. ECOG 0,1,2
3. Neu≥ 1.0\*10\^9/L, HGB ≥70g/L, PLT ≥ 50\*10\^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 Criteria:

1. Prior therapy for MIDD, with the exception of equal or less than 160 mg dexamethasone (or equivalent corticosteroid)
2. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
3. Presence of other tumors which is/are in advanced malignant stage and has/have systemic 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 subject or affect the results of the study.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting
• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting
• The First Affiliated Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Jin Lu — Peking University People's Hospital
• Study coordinator: Jin Lu
• Email: jin1lu@sina.com
• Phone: 86-13311491805

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.