Actively Recruiting
SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-08-17
35
Participants Needed
6
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of SVRd in NDMM patients presenting with extramedullary disease.
CONDITIONS
Official Title
SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 75 years old
- Confirmed diagnosis of multiple myeloma according to IMWG guidelines
- Newly diagnosed with extramedullary disease including paraskeletal plasmacytoma, soft tissue plasmacytoma, or other sites confirmed by imaging or biopsy (≥2 cm)
- Adequate blood counts: ANC ≥1.0 x 10^9/L, hemoglobin ≥75 x 10^9/L, platelets ≥50 x 10^9/L with ≥50% plasma cells in marrow
- Expected survival time of more than 3 months
- No active infectious disease
- Female patients of child-bearing potential must have a negative pregnancy test and agree to use two reliable contraception methods for six months after last medication dose
- Willingness and ability to comply with study visits, treatments, lab tests, and procedures
- Signed informed consent form indicating understanding and willingness to participate
You will not qualify if you...
- Presence of hepatitis B, hepatitis C, or other acquired or congenital immunodeficiency diseases
- Grade 2 or higher peripheral neuropathy or neuralgia as per NCI CTCAE v4.0
- Diagnosis of plasma cell leukemia
- History of serious thrombotic events
- Active or unstable cardiovascular problems including symptomatic ischemia, uncontrolled conduction abnormalities (except first-degree AV block or certain bundle branch blocks), NYHA Class III-IV heart failure, LVEF <40%, or recent myocardial infarction within 3 months
- Significant liver dysfunction (ALT or AST ≥3 times upper limit of normal)
- Serum bilirubin ≥1.5 times upper limit of normal
- Creatinine clearance less than 30 ml/min
- History of active cancer within past 5 years except certain skin or cervical cancers
- Major surgery within 30 days before treatment start
- Epilepsy, dementia requiring medication, or mental disorders impairing study compliance
- Serious physical or mental illnesses likely to interfere with study
- Psychological, social, or geographical conditions hindering compliance
- Current participation in another clinical trial
- Pregnant or breastfeeding women
- Other medical conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Changzhou Second People's Hospital
Changzhou, Jiangsu, China, 213000
Not Yet Recruiting
2
Nanjing First People's Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
3
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
4
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001
Not Yet Recruiting
5
Taizhou People's Hospital
Taizhou, Jiangsu, China, 225300
Not Yet Recruiting
6
Yancheng First People's Hospital
Yancheng, Jiangsu, China, 224006
Not Yet Recruiting
Research Team
Y
Yuanyuan Jin, Doctor
CONTACT
L
Lijuan Chen, Doctor
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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