An observational study in Multiple Myeloma and Minimal Residual Disease, sponsored by FengYan Jin. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by FengYan Jin · Observational
The aim of this study was to observe the rate of MRD conversion and the impact on survival in newly diagnosed multiple myeloma (NDMM) patients with persistent MRD positivity after induction and consolidation therapy (autologous hematopoietic stem cell transplantation or consolidation of the original regimen) who were switched to high-intensity therapy, and to compare the rate of persistent MRD-negativity, progression-free survival (PFS), and overall survival (OS) between the two groups in comparison with NDMM patients who achieved MRD-negativity after the same induction and consolidation therapy.
There is still an unmet clinical need as to whether NDMM patients with persistent MRD positive would benefit from switching to high-intensity therapy. The induction regimen (Dara+/- (Vd, Rd, Pd, VRd, VPd)) was selected based on the frail or high-risk status of NDMM patients. Transplantation or consolidation and maintenance regimens were adjusted by MRD status detected by NGF.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 80 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →FengYan Jin is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
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Diagnosed with multiple myeloma according to the 2014 IMWG multiple myeloma diagnostic criteria, receiving induction and consolidation therapy to achieve partial remission (PR) or better, and MRD-negative, or persistently MRD-positive and agreeing to adjust the treatment regimen.
Exclusion Criteria:
NDMM patients who obtained MRD negativity after induction and consolidation therapy
NDMM patients who MRD positivity after induction and consolidation therapy and agree to adjust the treatment regimen
Adjusted treatment-adjusted MRD-negative rates
To explore the rate of conversion to MRD-negative after adjusting treatment in NDMM patients with persistent MRD-positive status.
Time frame: through study completion, up to 2 years
Progression-Free Survival (PFS)
PFS were calculated from the enrollment to the first instance of disease progression, relapse, or death
Time frame: through study completion, up to 2 years
Overall Survival (OS)
OS were calculated from the time of enrollment to death or the last follow-up
Time frame: through study completion, up to 2 years
Persistent MRD-negative rates and survival
Persistent MRD-negative rates and survival (including PFS and OS) in both groups compared to NDMM patients who achieved MRD-negativity after the same induction and consolidation therapy
Time frame: through study completion, up to 2 years
Treatment related adverse event(TRAE)
Toxicity and safety will be reported based on the adverse events, as graded by CTCAE V5 and determined by routine clinical assessments.
Time frame: through study completion, up to 2 years
explore the molecular basis for the dynamic changes and differences in MRD
Bone puncture samples from routine clinical consultations were collected, and single-cell transcriptome sequencing technology was applied to analyze and compare the differences in MM cells (clones) and bone marrow microenvironment (including immunity, inflammation, and stroma) of MRD-transformed and non-transformed patients after adjusting the treatment regimen, using the samples before adjusting the treatment regimen as the baseline control, in order to explore the molecular basis for the dynamic changes and differences in MRD
Time frame: through study completion, up to 2 years
explore the elderly (especially debilitated) patients' MRD-adjusted treatment
For patients ≥65 years old, through the adjusted treatment-adjusted MRD-negative rates to explore the impact of strategy adjustment on elderly patients
Time frame: through study completion, up to 2 years
Plan to share: Undecided
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FengYan Jin