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

Launched by FIRST AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY · Jun 14, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how effective and safe two different treatment options are for people with primary multiple myeloma who have achieved a state called minimal residual disease (MRD) negativity after initial treatment. Specifically, it compares autologous stem cell transplantation (ASCT), where a patient receives their own stem cells, with other treatment regimens that do not involve stem cell transplantation. The main question the researchers want to answer is whether these non-ASCT treatments are just as good as ASCT for patients who have reached MRD negativity.

To join this study, participants need to be 18 to 70 years old and have been newly diagnosed with multiple myeloma. They should have shown a significant positive response to initial therapy, indicated by achieving MRD negativity. Participants can choose whether they want to receive ASCT or another treatment option. Throughout the trial, researchers will monitor how well each treatment works and any side effects that may occur. This trial is currently recruiting participants, and it’s important for anyone considering joining to understand the eligibility criteria, especially regarding their overall health and any pre-existing conditions.

Gender

ALL

Eligibility 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.