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
This trial does not accept healthy volunteersQualifiers
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 population
Diagnosed with primary multiple myeloma according to the 2014 IMWG multiple myeloma diagnostic criteria,aged ≥65 years who were either transplant-ineligible or had no intent for immediate transplant.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Overall response rate (at least PR) on induction therapy
Overall response rate(ORR) is defined as the percentage of participants with presence of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). ORR assessment will be based on International Myeloma Working Group (IMWG) response criteria.
Time frame
From the date of inclusion to the end of induction therapy, up to 8 months.Secondary outcomes
1
Rate of treatment discontinued(TD)
The effect of intensive or mild treatment based on dynamic frailty status on treatment discontinued(TD) in elderly newly diagnosed multiple myeloma.
Time frame
The time from the date of inclusion to the date of treatment discontinued from any cause, up to 24 months.2
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
Baseline, end of every induction cycle and maintenance cycle, until disease progression or treatment discontinued, up to 24 months.3
Early mortality(EM)
Early mortality is defined as death within 3, 6, 12 and 24 months (EM3,EM6,EM12 and EM24).
Time frame
The time from the date of inclusion to the date of death from any cause, up to 24 months.4
Progression-free survival(PFS)
Progression-free survival(PFS) is defined as the time from inclusion to the time of first documented evidence of disease progression or death from any cause. Individuals who are lost to follow-up or progression-free at the time of analysis will be censored at their last known date to be alive and progression-free. Disease progression is defined according to the IMWG Uniform Response Criteria for Multiple Myeloma.
Time frame
The time from the date of inclusion to the date of first documented evidence of disease progression or death from any cause, up to 24 months.Other outcomes
1
To establish a new and better comprehensive geriatric assessment system to predict prognosis of elderly NDMM
To establish a new and better comprehensive geriatric frailty assessment system that can predict TD and OS in NDMM patients, combining objective biological markers (biomarkers of sarcopenia, n-terminal pro-brain natriuretic peptide, inflammatory markers such as C-reactive protein, aging biomarkers, and immune markers).
Time frame
Through study completion, up to 24 months.2
To explore the value of sarcopenia in predicting treatment discontinued(TD) and prognosis of the elderly newly diagnosed multiple myeloma
Number of participants with imaging sarcopenia as assessed by dual-energy X-ray absorptiometry and whole-body low-dose CT;Number of participants with functional sarcopenia as assessed by grip strength and 6-meter walking speed;Number of participants with objective biomarkers in sarcopenia as assessed by peripheral blood test.
Time frame
Through study completion, up to 24 months.3
Minimal residual disease (MRD)
By using multiparameter flow cytometry and/or next-generation sequencing techniques dynamically monitor MRD status and its effect on OS and PFS
Time frame
Through study completion, up to 24 months.4
Discovery and identification of frailty biomarkers in elderly newly diagnosed multiple myeloma
Discovery and identification of frailty biomarkers in elderly newly diagnosed multiple myeloma.
Time frame
Through study completion, up to 24 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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