DFA: Dynamic Frailty Assessment for Guiding the Treatment in Older Adults With Newly Diagnosed Multiple Myeloma

Sponsor

FengYan Jin (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06099912

Collaborator

(none)

120

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Investigators designed the single-center, prospective real-world based clinical study with the aim of applying the standardized geriatric assessment system IMWG-FS internationally for dynamic frailty assessment of elderly newly diagnosed multiple myeloma(NDMM), guiding therapeutic decision based on their fit/frail status (fit → intensive; frail → mild), to observe their treatment tolerance, treatment related adverse events(TRAE), treatment discontinued(TD), and survival(progression survivaland overall survival).

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Frailty

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Dynamic Frailty Assessment for Guiding the Treatment in Older Adults With Newly Diagnosed Multiple Myeloma :a Prospective and Single-center Study

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2026

Outcome Measures

Primary Outcome Measures

Rate of treatment discontinued(TD) [The time from the date of inclusion to the date of treatment discontinued from any cause, up to 24 months.]
The effect of intensive or mild treatment based on dynamic frailty status on treatment discontinued(TD) in elderly newly diagnosed multiple myeloma.

Secondary Outcome Measures

Treatment related adverse event(TRAE) [Baseline, end of each induction cycle (each induction cycle is 21 days), end of each maintenance cycle (each maintenance cycle is 28 days), until disease progression or treatment discontinued, up to 24 months.]
Toxicity and safety will be reported based on the adverse events, as graded by CTCAE V5 and determined by routine clinical assessments.
Early mortality(EM) [The time from the date of inclusion to the date of death from any cause, up to 24 months.]
Early mortality is defined as death within 3, 6, 12 and 24 months(EM3,EM6,EM12 and EM24).
Overall response rate (ORR) [From the date of inclusion to the date of last follow-up, up to 24 months.]
Overall response rate 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.
Overall survival (OS) [The time from the date of inclusion to the date of death from any cause, up to 24 months]
In each case it is the time from inclusion to the time of death from any cause. Individuals who are lost to follow-up or still alive at the time of analysis will be censored at their last known date to be alive.
Progression-free survival(PFS) [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.]
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.

Other Outcome Measures

To establish a new and better comprehensive geriatric assessment system to predict prognosis of elderly NDMM [Through study completion, up to 24 months.]
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).
To explore the value of sarcopenia in predicting treatment discontinued(TD) and prognosis of the elderly newly diagnosed multiple myeloma [Through study completion, up to 24 months.]
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.
Minimal residual disease (MRD) [Through study completion, up to 24 months.]
By using multiparameter flow cytometry and/or next-generation sequencing techniques dynamically monitor MRD status and its effect on OS and PFS
Discovery and identification of frailty biomarkers in elderly newly diagnosed multiple myeloma [Through study completion, up to 24 months.]
Discovery and identification of frailty biomarkers in elderly newly diagnosed multiple myeloma.
To explore the prognostic significance of blood liquid biopsy based on platelet RNA sequencing for multiple myeloma [Through study completion, up to 24 months.]
Heterogeneity of disease as assessed by platelet RNA sequencing to explore the prognostic significance of blood liquid biopsy based on for multiple myeloma.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult males and females aged 65 years or above;
Diagnosed with primary multiple myeloma according to the 2014 IMWG multiple myeloma diagnostic criteria;
Multiple myeloma was first diagnosed without treatment;
The functional reserve of the organs can withstand systemic therapy;
Ask the informed consent of patients and their families to participate in the research voluntarily.

Exclusion Criteria:

There are active systemic viral, fungal, or bacterial infections that require systemic anti-infective treatment;
Unstable angina or New York Heart Association Grade III or IV congestive heart failure or uncontrolled malignant arrhythmias (except myocardial amyloid secondary to multiple myeloma);
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;
Non-signation of informed consent.