Rapid DFLC Response Predict CHR in AL Amyloidosis

RecruitingOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

October 26, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

July 1, 2026

Conditions
Systemic AL Amyloidosis
Interventions
DRUG

Dara IV

The treament follow the clinical routine practice, as daratumumab 16mg/kg iv qw OR dara SC 1800mg initially. The treatment schedule involve weekly administrations during cycles 1 to 2, following by biweekly administrations during cycles 3 to 6. Subsequently, monthly administrations are given as monotherapy.

DRUG

Bortezomib (drug)

Bortezomib is administered subcutaneously. The dosage range from 0.7 to 1.3 mg/m2 on days 1, 8, 15, and 22 of each cycle, for a maximum of 6 cycles

DRUG

Dexamethasone

Dexamethasone is administered intravenously at a dose of 40 mg weekly for each cycle, for a maximum of 6 cycles. For patients over 70 years of age or with severe edema, heart failure, or uncontrolled diabetes mellitus, dexamethasone can be administered at a dose of 10-20 mg per week.

DRUG

Cyclophosphamide (CTX)

Some patients may receive cyclophosphamide orally or intravenously at a dosage of 300 mg/m2 weekly.

DRUG

Dara SC

The treament follow the clinical routine practice, as daratumumab 16mg/kg iv qw OR dara SC 1800mg initially. The treatment schedule involve weekly administrations during cycles 1 to 2, following by biweekly administrations during cycles 3 to 6. Subsequently, monthly administrations are given as monotherapy.

Trial Locations (2)

100044

RECRUITING

Peking University People's Hospital, Beijing

100045

RECRUITING

Fuxing Hospital affiliated to Capital Medical University, Beijing

All Listed Sponsors
lead

Peking University People's Hospital

OTHER