Actively Recruiting
Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis
Led by Jin Lu, MD · Updated on 2024-12-30
40
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of AL amyloidosis confirmed by specific laboratory methods
- Newly diagnosed or previously treated systemic AL amyloidosis
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Measurable disease with specific blood markers: serum free light chain ≥2.0 mg/dL with abnormal ratio or monoclonal spike ≥5 g/L
- Symptomatic involvement of organs such as heart, kidney, liver, gastrointestinal tract, or peripheral nerves
- Adequate blood counts: absolute neutrophil count ≥1.0 x 10^9/L, hemoglobin ≥70 g/L, platelets ≥50 x 10^9/L
- Kidney function with eGFR ≥20 mL/min/1.73 m^2
- Written informed consent provided
- Use of contraception consistent with local regulations
You will not qualify if you...
- Diagnosis of active multiple myeloma or active lymphoplasmacytic lymphoma
- Presence of other advanced malignant tumors with systemic metastasis
- Severe or persistent infection that cannot be controlled effectively
- Severe autoimmune diseases or immunodeficiency disorders
- Active hepatitis B or hepatitis C infection
- HIV infection or syphilis infection
- Any condition that increases risk or may affect study results as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
Y
Yang Liu, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here