Individualized Dynamic Frailty-tailored Therapy (DynaFiT) in Elderly Patients With NDMM
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorFengYan Jin
About this trial
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.
Eligibility criteria
Qualifiers
Adult males and females aged ≥65 years who were either transplant-ineligible or had no intent for immediate transplant;
Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
IgA multiple myeloma: serum M-protein level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
Light chain multiple myeloma: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
Disqualifiers
There are active systemic viral, fungal, or bacterial infections that require systemic anti-infective treatment;
Severe organ dysfunction (New York Heart Association class III and IV or transaminases ≥5 normal level, except those caused by cardiac and hepatic amyloidosis secondary to MM)
Patients with prior history of hematologic or solid tumors treated with radiotherapy or chemotherapy(except ≥5 years);
Patients who currently have hematologic tumors or solid tumors that require radiotherapy or chemotherapy;
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
FengYan Jin
Lead sponsor
The First Hospital of Jilin University
Sponsor institution
Sun Yat-Sen University Cancer Center
Collaborator
Ruijin Hospital
Collaborator
Second Hospital of Shanxi Medical University
Collaborator
The First Affiliated Hospital of Air Force Medicial University
Collaborator
Source ClinicalTrials.gov