A Multicenter, Prospective Study Evaluating the DVd-Lite Regimen (Reduced-Dose Daratumumab-Based Therapy) in Patients with Light-Chain (AL) Amyloidosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500103075

Enrollment

Unknown

Registered

2025-05-23

Start date

2025-06-01

Completion date

Unknown

Last updated

2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AL Amyloidosis

Interventions

DVd-Lite Group:DVd-Lite Regimen (D-Daratumumab (SC/IV), Administered per prescribing information: 1800 mg (subcutaneous) or 800 mg (intravenous). During Cycles 1-2, the investigator may adjust the dos

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1: Newly diagnosed AL amyloidosis patients with a confirmed pathological diagnosis, classified as Mayo 2004 stage III. 2: Patients with an Eastern Cooperative Oncology Group (ECOG) performance status greater than 2.

Exclusion criteria

Exclusion criteria: 1: AL amyloidosis patients who have previously received anti-plasma cell therapy. 2: Patients who meet the diagnostic criteria for multiple myeloma as defined by the International Myeloma Working Group. 3: Pregnant or breastfeeding women. 4: Patients with an expected survival time of less than 6 months.

Design outcomes

Primary

Measure	Time frame
Overall survival;progression free survival, PFS;	—

Secondary

Measure	Time frame
major organ deterioration progression free survival;Time to Next Treatment;Serious Adverse Events;Duration of Response;Health-Related Quality of Life, HRQoL;Duration of Therapy, DoT;Hematologic Response Rate;Organ Response Rate;Adverse Event Rate;	—

Countries

China

Contacts

Public ContactWu Yu

West China Hospital of Sichuan University

wu_yu@scu.edu.cn+86 28 8542 2370

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026