Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis
NCT06342466 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2024-12-30
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.
Conditions
- Systemic Amyloidosis
Interventions
- DRUG
-
Bortezomib 1.3mg/m2 sc weekly
- DRUG
-
4mg per day taken orally on 1-21 of repeated 28-day cycles
- DRUG
-
Dexamethasone 20mg-40mg weekly
Sponsors & Collaborators
-
Jin Lu, MD
lead OTHER
Principal Investigators
-
Jin Lu · Peking University People's Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-06
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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