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

Study Overview
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Brief Summary
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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).

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

Conditions
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Multiple Myeloma, Frailty

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The time from the date of inclusion to the date of treatment discontinued from any cause, up to 24 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 
| Early mortality(EM) | Early mortality is defined as death within 3, 6, 12 and 24 months(EM3,EM6,EM12 and EM24). | The time from the date of inclusion to the date of death from any cause, up to 24 months. | 
| Overall response rate (ORR) | 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. | From the date of inclusion to the date of last follow-up, up to 24 months. | 
| Overall survival (OS) | 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. | The time from the date of inclusion to the date of death from any cause, up to 24 months | 
| 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Newly diagnosed multiple myeloma, Elderly, Dynamic treatment