Primary Multiple Myeloma Who Achieved MRD Negativity After Induction Therapy, ASCT or Not
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorFirst Affiliated Hospital of Zhejiang University
About this trial
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 criteria
Qualifiers
Newly diagnosed multiple myeloma according to the criteria of International Working Group of Myeloma
Age ranges from 18-70 years old
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.
At enrollment, score of Eastern Cooperative Oncology Group (ECOG) should be 0-2.
Disqualifiers
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%.
Extracellular plasma cell disease, central invasion of myeloma, plasma cell leukemia
History of other malignant tumors within the past 5 years
Patients with HIV, active tuberculosis, clinically active hepatitis A, B, or C
Trial design
Treatments tested in this trial
- Transplant, Autologous
- Chemotherapy drug
Treatment groups
210 Participants
are divided into 2 treatment groupsSponsors and collaborators
First Affiliated Hospital of Zhejiang University
Lead sponsor
First Affiliated Hospital of Wenzhou Medical University
Collaborator
The Affiliated Hospital of Medical College, Ningbo University
Collaborator
Dongyang People's Hospital
Collaborator
Source ClinicalTrials.gov