RecruitingNCT06463717

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

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


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

210 participants

Start Date

Dec 1, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial investigates the best maintenance strategy after stem cell transplant for people with multiple myeloma who achieved very deep remission (MRD negativity) after induction treatment — testing whether transplant or continued drug treatment offers the best long-term outcomes. **You may be eligible if...** - You are between 18 and 70 years old with a new diagnosis of multiple myeloma - After 4–6 cycles of induction therapy, you achieved a very good partial response or better, including MRD negativity (no detectable cancer cells at a very sensitive level) - Your ECOG performance score is 0–2 and major organ function is within normal limits - Your expected survival is more than 3 months **You may NOT be eligible if...** - You have two or more high-risk genetic changes in your myeloma cells (such as del17p, t(4;14), or amp1q) - You have plasma cell leukemia or cancer in the central nervous system - You have had another cancer in the past 5 years - You have HIV, active tuberculosis, or active hepatitis A, B, or C - You have serious uncontrolled infections, heart failure, or diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTransplant, Autologous

High-dose melphalan followed by autologous stem cell transplantation

DRUGChemotherapy drug

Regimen such as Bortezomib plus Lenalidomide plus Dexamethasone


Locations(1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

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NCT06463717


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