Individualized Dynamic Frailty-tailored Therapy (DynaFiT) in Elderly Patients With NDMM

Trial Title: Individualized Dynamic Frailty-tailored Therapy (DynaFiT) in Elderly Patients With NDMM

NCT ID: NCT06099912

Condition: Multiple Myeloma
Frailty

Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Frailty

Conditions: Keywords:
Newly diagnosed multiple myeloma
Frailty
Elderly
Dynamic frailty-tailored therapy

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Summary: 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.

Detailed description: Older patients with MM represent a heterogeneous population with different fitness/frailty statuses. Unlike fit patients who can benefit from intensive therapies due to their endurance, frail patients are often susceptible to treatment-related toxicity, leading to treatment discontinuation and poor outcomes. More importantly, frailty can diminish the prognostic impact of disease-related factors over disease trajectory. Thus, it is of utmost importance to determine the fitness/frailty status for treatment decision-making that carefully balances efficacy and safety in this vulnerable population. However, geriatric assessment is often conducted at diagnosis in clinical practice. Although baseline frailty status, as a static risk factor, is significantly associated with OS, its predictive ability decreases over time. Of note, emerging evidence indicates that the fitness/frailty status is highly dynamic because of age increase, disease trajectory, and treatment, raising the notion that frailty-tailored therapy should be designed based on the baseline fitness/frailty status and also according to its longitudinal changes during the treatment course. Thus, current frailty status better predicts OS. To improve outcomes in elderly patients, this study was designed to investigate an entirely novel therapeutic strategy, the dynamic frailty-tailored therapy, in elderly MM patients with different fitness/frailty statuses.

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Adult males and females aged ≥65 years who were either transplant-ineligible or had no intent for immediate transplant; - Subject must have documented multiple myeloma as defined by the criteria below: Monoclonal plasma cells in the bone marrow 10% or presence of a biopsy-proven plasmacytoma; Measurable disease as defined by any of the following: - 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. - Has not had prior systemic therapy for multiple myeloma; - The functional reserve of the organs can withstand systemic therapy; - Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the ICF. Exclusion Criteria: - 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; - Non-signation of informed consent.

Gender: All

Minimum age: 65 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: The First Hospital of Jilin University

Address:
City: Changchun
Zip: 130021
Country: China

Status: Recruiting

Contact:
Last name: Fengyan Jin, Professor

Phone: +8613844989638
Email: fengyanjin@jlu.edu.cn

Start date: September 8, 2021

Completion date: September 8, 2029

Lead sponsor:
Agency: FengYan Jin
Agency class: Other

Source: The First Hospital of Jilin University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06099912