Actively Recruiting
A Study of VRd-based Regimen Combined With CART-ASCT-CART2 Treatment in NDMM Patients With P53 Abnormalities
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-04
20
Participants Needed
1
Research Sites
205 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(Bortezomib, Lenalidomide and Dexamethasone)-based regimen combined with CART-ASCT-CART2 in patients with newly diagnosed multiple myeloma with p53 gene abnormalities.
CONDITIONS
Official Title
A Study of VRd-based Regimen Combined With CART-ASCT-CART2 Treatment in NDMM Patients With P53 Abnormalities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to give written informed consent
- Age 18 to 65 years
- Newly diagnosed multiple myeloma according to accepted Chinese guidelines (2022)
- No prior anti-multiple myeloma chemotherapy, hormone therapy (except short-term symptom control), or extensive pelvic radiotherapy
- At least one measurable multiple myeloma lesion including serum M protein 1.0 g/dL, urine M protein 200 mg/24h, or abnormal serum free light chain ratio with affected light chain 10 mg/dL
- Presence of p53 gene abnormalities confirmed by FISH or sequencing with cut-off 20%
- ECOG performance status 0 or 1
- No active infection
- Screening blood biochemistry within protocol limits: bilirubin <1.5 x ULN, AST/ALT <3 x ULN, creatinine clearance 60 mL/min
- Normal lung function and oxygen saturation 92% on room air
- Routine blood tests within specified limits and no recent transfusions or supportive treatments
- Able to take anticoagulant therapy as recommended
- Women not pregnant or breastfeeding and agree to avoid pregnancy during and 12 months after study; men agree their partners avoid pregnancy
- Willing and able to complete study procedures and follow-up
You will not qualify if you...
- Plasma cell leukemia
- Active amyloidosis
- Multiple myeloma involving central nervous system
- Unsuitable for autologous stem cell transplantation due to severe cardiopulmonary disorders
- Peripheral neuropathy grade greater than 2 or with pain at baseline
- Known intolerance or contraindication to BCMA-CAR-T cell products
- Unstable or active cardiovascular disease including recent heart attack, uncontrolled hypertension, significant conduction abnormalities, severe heart failure, low left ventricular ejection fraction, recent stroke or serious thrombotic event
- HIV positive
- Active hepatitis B or C infection without confirmed negative DNA/RNA tests
- Life expectancy less than 3 months
- Pregnant or breastfeeding women
- Active gastrointestinal dysfunction affecting medication intake
- Recent major surgery within 2 weeks or not fully recovered
- Live attenuated vaccine within 4 weeks prior to treatment
- Serious mental or medical illness affecting treatment or consent
- Contraindicated medications or supportive therapies
- Diseases or complications interfering with study
- Unwillingness or inability to comply with study protocol
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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