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

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · May 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a combination of four medications—daratumumab, bortezomib, cyclophosphamide, and dexamethasone—to see how well they work in treating patients with a condition called monoclonal immunoglobulin deposition disease (MIDD). This disease can affect the kidneys, and the trial is open to adults aged 65 to 74 who have just been diagnosed and have not yet started treatment for this condition. Participants will be closely monitored during the study to assess how the treatment affects their health.

To join the trial, patients must meet certain criteria. They should have a confirmed diagnosis of MIDD, be in good enough overall health (measured by certain blood tests), and be able to understand and sign a consent form. However, those who have received previous treatment for MIDD or have other serious health conditions, like advanced cancer or severe infections, may not be eligible. If you or a loved one is interested in this study, it could be a chance to receive a new treatment option while contributing to important medical research.

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ALL

Eligibility criteria

• 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.

Trial Officials