NCT06342466

Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis

A Study of Bortezomib, Pomalidomide, Dexamethasone in Patients with Systemic AL Amyloidosis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Jin Lu, MD · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed or previous treated systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. The primary outcome is hematologic very good partial response and complete response rate at 6 months.

Detailed description

Proteasome inhibitor and immunmodulators have synergistic effect for plasma cell dyscrasia. Due to the fact that more than 70-80% of patients with amyloidosis have renal involvement, the application of lenalidomide is limited. Thus, the investigators designed this open-label, multicenter, phase 2 study for newly diagnosed or previously treated systemic AL amyloidosis with bortezomib, pomalidomide and dexamethasone regimen.

Conditions

• Systemic Amyloidosis

Interventions

Type	Name	Description
DRUG	Bortezomib	Bortezomib 1.3mg/m2 sc weekly
DRUG	Pomalidomide	4mg per day taken orally on 1-21 of repeated 28-day cycles
DRUG	Dexamethasone	Dexamethasone 20mg-40mg weekly

Timeline

• Start date: 2024-05-06
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-04-02
• Last updated: 2024-12-30

Locations

1 site across 1 country: China