Comparing stem cell transplant and non-transplant treatments in multiple myeloma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.