Comparing stem cell transplant and non-transplant treatments in multiple myeloma patients
Comparing the Efficacy and Safety of Autologous Hematopoietic Stem-cell Transplantation Versus Non Transplantation Regimen in Primary Multiple Myeloma Achieved MRD Negativity After Induction: A Multiple Center, Prospective Cohort Study
This study is testing whether a stem cell transplant works better than other treatments for multiple myeloma patients who have very low levels of the disease after their initial therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, prednisone |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06463717 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the efficacy and safety of autologous hematopoietic stem-cell transplantation (ASCT) versus non-ASCT regimens in patients with primary multiple myeloma who have achieved minimal residual disease (MRD) negativity after induction therapy. Participants will choose between ASCT and non-ASCT treatment options, and researchers will evaluate any significant differences in outcomes between the two groups. The study focuses on understanding whether non-ASCT regimens can provide similar benefits to ASCT in terms of efficacy and safety.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed multiple myeloma patients aged 18-70 who have achieved MRD negativity after induction therapy.
Not a fit: Patients with high-risk cytogenetic abnormalities or those who do not achieve MRD negativity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into less invasive treatment options for multiple myeloma patients while maintaining efficacy.
How similar studies have performed: Other studies have explored treatment regimens for multiple myeloma, but this specific comparison of ASCT versus non-ASCT in MRD-negative patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Newly diagnosed multiple myeloma according to the criteria of International Working Group of Myeloma 2. Age ranges from 18-70 years old 3. Achieved MRD negativity and at least very good partial response in clinical response after 4-6 courses of induction therapy. MRD is measured by MRD by multicolor flow with a sensitivity of 10-5. 4. At enrollment, score of Eastern Cooperative Oncology Group (ECOG) should be 0-2. 5. Organ function requirement: Blood bilirubin ≤ 2mg/dL (35 μ mol/L), Alanine aminotransferase/Aspartate aminotransferase below 2 times the upper limit of normal value, Creatinine clearance rate (Ccr) ≥ 30ml/min and Cardiac ejection fraction ≥50%. 6. Expected survival more than 3 months. Exclusion Criteria: 1. Two or more high-risk cytogenetic abnormalities, including del (17p), t (4; 14), t (14; 16), del (1p), amp (1q). Fluorescence in situ hybridization was used to analyze CD138 positive sorted cells, with cut off value of 15% for translocation, 10% for deletion, and amp (1q) of 20%. 2. Extracellular plasma cell disease, central invasion of myeloma, plasma cell leukemia 3. History of other malignant tumors within the past 5 years 4. Patients with HIV, active tuberculosis, clinically active hepatitis A, B, or C 5. Other serious condition that may restrict patients from continuing treatment (such as advanced infection, uncontrolled diabetes, severe cardiac insufficiency, or angina pectoris) 6. General condition not suitable for chemotherapy 7. Pregnant or lactating women 8. Suffering from other serious organic diseases and mental disorders.
Where this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Haitao Meng — Zhejiang University
- Study coordinator: Liangshun You
- Email: youliangshun@zju.edu.cn
- Phone: +86 15088687797
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.