Actively Recruiting
A Prospective Study Comparing DRd With VRd-lite in Elderly Newly Diagnosed Multiple Myeloma
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-08-17
112
Participants Needed
6
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to compare the efficacy and safety of daratumumab, lenalidomide and dexamethasone (DRd) to that of modified bortezomib, lenalidomide and dexamethasone (VRd-lite), in terms of progression-free survival and minimal residual disease negativity rate in elderly participants with newly diagnosed multiple myeloma.
CONDITIONS
Official Title
A Prospective Study Comparing DRd With VRd-lite in Elderly Newly Diagnosed Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- Newly diagnosed multiple myeloma with measurable disease per International Myeloma Working Group criteria
- Diagnosis includes at least one CRAB or SLiM criterion
- Measurable disease defined by specific serum or urine monoclonal protein levels or free light chain abnormalities
- Expected survival longer than 3 months
- No active infectious disease
- Ability to understand the disease and voluntarily consent to treatment and follow-up
- Signed informed consent by the patient or immediate family member
You will not qualify if you...
- Active hepatitis B, hepatitis C, or other acquired or congenital immunodeficiency diseases
- Peripheral neuropathy or neuropathic pain grade 2 or higher, except due to extramedullary disease compression
- Plasma cell leukemia or non-bone-related extramedullary lesions
- Severe thrombotic events prior to treatment
- Liver dysfunction with elevated liver enzymes (≥ 2.5 times upper limit of normal)
- Total bilirubin ≥ 1.5 times upper limit of normal
- Major surgery within 30 days before enrollment
- Epilepsy, dementia, or other mental disorders requiring treatment that impair study participation
- Serious physical or mental illness interfering with study participation as judged by investigator
- Drug abuse or medical, psychological, or social conditions interfering with participation or evaluation
- Receiving other experimental drug treatments
- Pregnant or lactating women
- Investigator judgment that participant is unsuitable for enrollment
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
Actively Recruiting
2
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
3
Nanjing First People's Hospital
Nanjing, Jiangsu, China, 21000
Actively Recruiting
4
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001
Actively Recruiting
5
Taizhou People's Hospital
Taizhou, Jiangsu, China, 225300
Actively Recruiting
6
Yancheng First People's Hospital
Yancheng, Jiangsu, China, 224006
Actively Recruiting
Research Team
Y
Yuanyuan Jin, Doctor
CONTACT
L
Lijuan Chen
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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