Actively Recruiting
Risk Stratification and MRD-driven Maintenance for MM After ASCT
Led by Peking University People's Hospital · Updated on 2024-11-25
100
Participants Needed
4
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study evaluates the maintenance strategy based on risk stratification and MRD status after stem cell transplantation. This is a single-arm, multicenter, prospective study. Participants who are R2-ISS 1,2 and MRD negative receive the single drug lenalidomide maintenance. In other circumstances, for example, patients who are R2-ISS 3 or 4 will receive daratumumab combined with lenalidomide regardless of MRD status, while patients with MRD positivity will also receive daratumumab plus lenalidomide maintenance.
CONDITIONS
Official Title
Risk Stratification and MRD-driven Maintenance for MM After ASCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed multiple myeloma with at least 4 cycles of induction therapy
- Received high-dose therapy and autologous stem cell transplantation within 12 months of induction start
- Within 6 months of autologous stem cell transplantation
- Achieved partial response or better before maintenance
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- Allows post-transplant consolidation therapy
- Absolute neutrophil count 91.0 x 10^9/L, hemoglobin 85 g/L
- Platelets 75 x 10^9/L if bone marrow plasma cells less than 50%, or platelets 50 x 10^9/L if 50% or more
- No active infection
- Total bilirubin less than 1.5 times upper limit of normal (or less than 3 times for Gilbert's syndrome)
- AST and ALT less than 3 times upper limit of normal
- Creatinine clearance of 45 mL/min or higher
You will not qualify if you...
- Refractory or intolerant to lenalidomide in Arm A
- Refractory or intolerant to both lenalidomide and daratumumab in Arm B
- Disease progression on multiple myeloma therapy before screening
- Chronic obstructive pulmonary disease with FEV1 less than 50% of predicted
- Moderate or severe persistent asthma within past 2 years or uncontrolled asthma currently
- History of stroke or serious blood clot within 12 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Fuxing Hospital
Beijing, Beijing Municipality, China, 100038
Actively Recruiting
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
3
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
4
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
Actively Recruiting
Research Team
Y
Yang Dr, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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