RecruitingPhase 2NCT06418477

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

Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with Monoclonal Immunoglobulin Deposition Disease


Sponsor

Peking University People's Hospital

Enrollment

20 participants

Start Date

Jun 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of four drugs — daratumumab, bortezomib, cyclophosphamide, and dexamethasone — to treat a rare kidney disease called monoclonal immunoglobulin deposition disease (MIDD), where abnormal proteins produced by certain blood cells deposit in the kidneys and cause damage. **You may be eligible if...** - You have been diagnosed with MIDD and have not yet received treatment targeting the underlying plasma cell disease - Your general health is acceptable (ECOG 0, 1, or 2) - Your blood counts and liver function are within acceptable ranges - You understand the study and have signed informed consent **You may NOT be eligible if...** - You have previously received treatment for MIDD (other than a small amount of steroids) - You meet the criteria for active multiple myeloma or active lymphoplasmacytic lymphoma - You have another advanced cancer with widespread spread - You have an active serious infection that cannot be controlled - You have a severe autoimmune disease or immune deficiency - You have active hepatitis B, hepatitis C, HIV, or syphilis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDara-CyBorD

Patient will receive Dara-CyBorD (Daratumumab, Bortezomib, Cyclophosphamide, Dexamethasone) for at least 6 cycles, and then Daratumumab maintainance. Drug: Daratumumab: 16mg/kg IV dose OR 1800 mg subcutaneously Drug: Cyclophosphamide: 300 mg/m\^2 as an oral or IV dose Drug: Bortezomib: 1.3 mg/m\^2 as an subcutaneous (SC) injection. Drug: Dexamethasone: 20-40mg Patients will receive the above drugs (Dara-CyBorD) on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. Daratumumab will be administered weekly for the first 8 weeks (2 cycles), then every 2 weeks for 4 cycles (cycles 3-6), and then every 4 weeks until progression of disease or subsequent therapy for a maximum of 1 years. Note: If patients achieve less than hematologic VGPR by cycle 3 or less than PR by cycle 2, treatment plan will be allowed to discontinued, according to treatment principle in systemic light chain amyloidosis.


Locations(3)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT06418477


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