Actively Recruiting
Primary Multiple Myeloma Who Achieved MRD Negativity After Induction Therapy, ASCT or Not
Led by First Affiliated Hospital of Zhejiang University · Updated on 2024-06-24
210
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Zhejiang University
Lead Sponsor
F
First Affiliated Hospital of Wenzhou Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this observational study is to compare the efficacy and safety of autologous hematopoietic stem-cell transplantation (ASCT) versus non ASCT regimens in primary multiple myeloma patients achieved MRD negativity after induction. The main question it aims to answer is: In primary multiple myeloma patients who achieved MRD negativity after induction, non ASCT regimens are not inferior to ASCT or not? Participants will receive ASCT or non ASCT regimen according to their own choice. Researchers will compare ASCT and non ASCT group see if any significant difference in efficacy and safety.
CONDITIONS
Official Title
Primary Multiple Myeloma Who Achieved MRD Negativity After Induction Therapy, ASCT or Not
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed multiple myeloma according to International Working Group of Myeloma criteria
- Age between 18 and 70 years old
- Achieved MRD negativity and at least very good partial response after 4-6 courses of induction therapy
- Eastern Cooperative Oncology Group (ECOG) score of 0-2 at enrollment
- Blood bilirubin C264 2mg/dL (35 BC mol/L), ALT/AST below twice the upper limit of normal, creatinine clearance rate E9 30ml/min, cardiac ejection fraction E9 50%
- Expected survival longer than 3 months
You will not qualify if you...
- Two or more high-risk cytogenetic abnormalities such as del(17p), t(4;14), t(14;16), del(1p), amp(1q)
- Extramedullary plasma cell disease, central nervous system involvement, plasma cell leukemia
- History of other cancers within the past 5 years
- HIV infection, active tuberculosis, or active hepatitis A, B, or C
- Serious conditions restricting treatment like advanced infection, uncontrolled diabetes, severe heart failure, or angina
- General condition unsuitable for chemotherapy
- Pregnant or breastfeeding women
- Severe organic diseases or mental disorders
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
L
Liangshun You
CONTACT
Q
Qiumei Yao
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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