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

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 15, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Monoclonal Gammopathy of Renal Significance
Interventions
DRUG

Dara-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."

Trial Locations (3)

100005

RECRUITING

Peking Union Medical College Hospital, Beijing

100044

RECRUITING

Peking University People's Hospital, Beijing

510062

RECRUITING

The First Affiliated Hospital, Sun Yat-sen University, Guangzhou

All Listed Sponsors
lead

Peking University People's Hospital

OTHER