Actively Recruiting
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd)-Based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With Primary Plasma Cell Leukemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-03
20
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, open-label study to evaluate the efficacy and safety of VRD-based regimen combined with BCMA CAR-T in transplant-ineligible patients with primary plasma cell leukemia
CONDITIONS
Official Title
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd)-Based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With Primary Plasma Cell Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosed with primary plasma cell leukemia based on IMWG criteria (circulating plasma cells 5% or more or absolute tumor plasma cells over 2 x 10^9/L)
- Measurable disease by serum or urine M-protein levels or abnormal free-light chain levels
- Not eligible for high-dose chemotherapy with stem cell transplant due to age, performance status, or other medical reasons
- Bone marrow sample confirmed BCMA-positive
- Screening blood tests within 14 days before enrollment meet specified liver and kidney function criteria
- Routine blood tests within 7 days meet specified white blood cell, neutrophil, hemoglobin, and platelet counts
- Able to take prophylactic anticoagulant therapy as recommended
- Women not pregnant or breastfeeding and agree to avoid pregnancy during study and 12 months after; male patients agree their partners will avoid pregnancy during this time
You will not qualify if you...
- Active amyloidosis
- Central nervous system involvement
- Prior BCMA-targeted or CAR-T therapy
- Peripheral neuropathy greater than grade 2 or with pain at baseline
- Known intolerance or allergy to study drugs or CAR-T cells
- HIV positive
- Hepatitis B or C infection
- Life expectancy less than 6 months
- Pregnant or breastfeeding women
- Active gastrointestinal issues affecting swallowing or absorption of medication
- Recent major surgery within 2 weeks or not fully recovered
- Live attenuated vaccine within 4 weeks prior to treatment
- Serious mental or medical conditions affecting treatment or consent
- Contraindicated medications or supportive therapies
- Other diseases or complications interfering with the study
- Unwilling or unable to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China
Actively Recruiting
Research Team
G
Gang An, PhD&MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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