Primary Multiple Myeloma Who Achieved MRD Negativity After Induction Therapy, ASCT or Not

Summary

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.

Eligibility

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.

Conditions3

Interventions2

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