Actively Recruiting
Individualized Dynamic Frailty-tailored Therapy (DynaFiT) in Elderly Patients With NDMM
Led by FengYan Jin · Updated on 2026-02-12
131
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
Sponsors
F
FengYan Jin
Lead Sponsor
S
Sun Yat-Sen University Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Frailty is dynamic and confers poor outcomes in elderly patients with newly diagnosed multiple myeloma (NDMM), mainly because of the high prevalence of treatment discontinuation due to intolerability. We designed a multi-center prospective study (DynaFiT) based on our real-life practice to evaluate the feasibility and benefits of a dynamic frailty-tailored therapy in elderly patients with different fitness/frailty statuses. Since Dara-based treatment have recently become the new standard regimens, in this amendment of the study, daratumumab added to VRd is recommended as induction therapy regimen.
CONDITIONS
Official Title
Individualized Dynamic Frailty-tailored Therapy (DynaFiT) in Elderly Patients With NDMM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 65 years or older who are either not eligible for transplant or do not plan immediate transplant
- Diagnosed with multiple myeloma confirmed by 10% or more monoclonal plasma cells in the bone marrow or biopsy-proven plasmacytoma
- Measurable disease with serum or urine monoclonal protein levels meeting specified thresholds
- No prior systemic therapy for multiple myeloma
- Organs must have sufficient function to tolerate systemic therapy
- Able and willing to provide informed consent and follow study requirements
You will not qualify if you...
- Active systemic viral, fungal, or bacterial infections requiring treatment
- Severe organ dysfunction defined as NYHA class III or IV heart failure or high transaminase levels, except if caused by amyloidosis secondary to multiple myeloma
- History of hematologic or solid tumors treated with chemotherapy or radiotherapy within the past 5 years
- Current hematologic or solid tumors requiring chemotherapy or radiotherapy
- Failure to provide informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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