Multiple myeloma.
Shaji K Kumar, Vincent Rajkumar, Robert A Kyle...
https://pubmed.ncbi.nlm.nih.gov/28726797Actively Recruiting
Age: 18Years +
All Genders
ID06109233
A Perspective Study of the MRD-tailored Therapy in Patients With Newly Diagnosed Multiple Myeloma With Persistent Minimal Residual Disease After Initial Treatment
Led by FengYan Jin · Updated on 2024-07-05
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on newly diagnosed multiple myeloma (NDMM) patients who have minimal residual disease (MRD) after initial treatment. It aims to observe the rate of MRD conversion and the impact on survival for patients who remain MRD positive after induction and consolidation therapy. The study also compares outcomes between patients who achieve MRD negativity and those who remain MRD positive but switch to high-intensity therapy. The research addresses the unmet need of understanding if switching to more intense treatment benefits NDMM patients with persistent MRD positivity. Patients receive an induction regimen tailored by their frailty or risk status, including Dara with or without combinations such as Vd, Rd, Pd, VRd, or VPd. Following induction, they undergo autologous hematopoietic stem cell transplantation or consolidation therapy adjusted according to MRD status detected by next-generation flow (NGF). The study groups include patients who achieve MRD negativity after initial therapy and those who remain MRD positive and agree to modify their treatment. Participants are monitored for up to two years, with the primary outcome measuring the rate of treatment-adjusted MRD negativity. Secondary outcomes include progression-free survival, overall survival, persistent MRD-negative rates, and treatment-related adverse events. The study collects data through regular assessments to evaluate survival and disease progression, providing important information about the impact of MRD-guided therapy in NDMM patients.
CONDITIONS
Brief Title
A Perspective Study of the MRD-tailored Therapy in Patients With Newly Diagnosed Multiple Myeloma With Persistent Minimal Residual Disease After Initial Treatment
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Diagnosed with newly diagnosed symptomatic multiple myeloma as defined by 2014 International Myeloma Working Group criteria
- Achieved a partial response or better to at least one prior treatment regimen
- Women of childbearing potential agree to use two reliable birth control methods or abstain from heterosexual intercourse, with negative pregnancy tests before randomization
- Signed informed consent indicating understanding and willingness to participate
You will not qualify if you...
- Diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma
- Relapsed and refractory myeloma defined as disease nonresponsive during salvage therapy or progressing within 60 days after last therapy
- Primary refractory myeloma defined as disease nonresponsive without achieving minimal response
- Inability to comply with study protocol or any condition that may prevent or confound assessments as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 2 years
Participants with newly diagnosed multiple myeloma are observed for minimal residual disease (MRD) status after initial treatment and may have treatment adjustments based on their MRD results.
Regular visits to monitor MRD status and adjust treatment as needed
Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Progress and Paradigms in Multiple Myeloma.
Kenneth C Anderson
https://pubmed.ncbi.nlm.nih.gov/28151709The multiple myelomas - current concepts in cytogenetic classification and therapy.
Shaji K Kumar, S Vincent Rajkumar
https://pubmed.ncbi.nlm.nih.gov/29686421Metabolic signature identifies novel targets for drug resistance in multiple myeloma.
Patricia Maiso, Daisy Huynh, Michele Moschetta...
https://pubmed.ncbi.nlm.nih.gov/25769724Hedgehog and retinoid signaling alters multiple myeloma microenvironment and generates bortezomib resistance.
Salvador Alonso, Daniela Hernandez, Yu-Ting Chang...
https://pubmed.ncbi.nlm.nih.gov/27775549Differentiation stage of myeloma plasma cells: biological and clinical significance.
B Paiva, N Puig, M T Cedena...
https://pubmed.ncbi.nlm.nih.gov/27479184Current applications of multiparameter flow cytometry in plasma cell disorders.
T Jelinek, R Bezdekova, M Zatopkova...
https://pubmed.ncbi.nlm.nih.gov/29053157Next Generation Flow for highly sensitive and standardized detection of minimal residual disease in multiple myeloma.
J Flores-Montero, L Sanoja-Flores, B Paiva...
https://pubmed.ncbi.nlm.nih.gov/28104919Critical evaluation of ASO RQ-PCR for minimal residual disease evaluation in multiple myeloma. A comparative analysis with flow cytometry.
N Puig, M E Sarasquete, A Balanzategui...
https://pubmed.ncbi.nlm.nih.gov/23860448Comparative analysis of minimal residual disease detection by multiparameter flow cytometry and enhanced ASO RQ-PCR in multiple myeloma.
R Silvennoinen, T Lundan, V Kairisto...
https://pubmed.ncbi.nlm.nih.gov/25303369