A Perspective, Single Center Study of the MRD-tailored Therapy in Patients With Newly Diagnosed Multiple Myeloma With Persistent Minimal Residual Disease After Initial Treatment

Study Purpose

The investigators designed the present study with the aim of observing the rate of MRD conversion and its impact on survival in primary multiple myeloma (NDMM) patients with persistent MRD positivity after induction and consolidation therapy (autologous hematopoietic stem cell transplantation or consolidation of the original regimen) after tonification therapy and comparing them with the same NDMM patients who obtained MRD negativity after induction and consolidation therapy, and observing the rate of persistent MRD negativity, progression-free survival (PFS), and overall survival in the two groups. progression survival (PFS) and overall survival (OS).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age of 18 years or older and gender; 2. Diagnosed with primary multiple myeloma according to the 2014 IMWG multiple myeloma diagnostic criteria, receiving induction and consolidation therapy to achieve partial remission (PR) and above, and MRD-negative, or persistently MRD-positive and agreeing to adjust the treatment regimen; 3. No progression of extramedullary plasmacytoma or new bone destruction and extramedullary plasmacytoma confirmed by whole-body low-dose CT, MRI, or PET-CT after induction and consolidation therapy; 4. Females of childbearing age must have a negative pregnancy test prior to enrollment and agree to use contraception during the study and for 3 months after the last treatment; 5. Subjects and family members agree to participate in the study and sign an informed consent form.

Exclusion Criteria:

1. Failure to achieve PR after induction and consolidation therapy; 2. Relapsed multiple myeloma; 3. disagreed to participate in this clinical study.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06109233
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	FengYan Jin
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma, Minimal Residual Disease

Arms & Interventions

Arms

: MRD negativity

NDMM patients who obtained MRD negativity after induction and consolidation therapy

: MRD positivity

NDMM patients who MRD positivity after induction and consolidation therapy and agree to adjust the treatment regimen

Interventions

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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