Actively Recruiting
Study of Bortezomib, Pomalidomide, and Dexamethasone for Patients with Systemic AL Amyloidosis Phase 2 Open-Label Trial
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
Researchers are evaluating a treatment combination for people with systemic light chain (AL) amyloidosis, a condition that affects organs like the kidneys and heart. This open-label, multicenter Phase 2 study includes participants who are newly diagnosed or have received previous treatment. The investigation focuses on assessing how well the treatment works by measuring blood response rates after six months. The study involves giving participants three drugs: bortezomib, pomalidomide, and dexamethasone. Bortezomib is given as a weekly injection under the skin at a dose of 1.3 mg/m2. Pomalidomide is taken orally at 4 mg daily for 21 days in a 28-day cycle. Dexamethasone is taken weekly at doses between 20 mg and 40 mg. Approximately 40 participants will receive this combined therapy. Throughout the study, participants will be monitored closely with blood tests to evaluate their response to treatment, specifically looking at hematologic very good partial response and complete response rates at six months. Other assessments include organ function and safety evaluations. The study lasts for at least six months, with ongoing tracking of treatment effects and participant health.
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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