Dynamic frailty-tailored therapy for elderly patients with newly diagnosed multiple myeloma
Individualized Dynamic Frailty-tailored Therapy (DynaFiT) in Elderly Patients With Newly Diagnosed Multiple Myeloma: a Prospective and Multi-center Study
This study is testing a new treatment plan for older patients with newly diagnosed multiple myeloma to see if adjusting their therapy based on their fitness level helps them tolerate the treatment better and have improved outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 131 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | The First Hospital of Jilin University Academic / other |
| Drugs / interventions | chemotherapy, daratumumab |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT06099912 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and benefits of a dynamic frailty-tailored therapy specifically designed for elderly patients with newly diagnosed multiple myeloma (NDMM). It recognizes that frailty is a dynamic condition that affects treatment outcomes and aims to adjust therapy based on the patient's current fitness and frailty status throughout the treatment course. By incorporating real-life practices and focusing on the unique needs of frail patients, the study seeks to improve treatment tolerability and overall outcomes. The intervention includes the use of daratumumab-based regimens as part of the treatment strategy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 and older with newly diagnosed multiple myeloma who are not eligible for immediate transplant.
Not a fit: Patients who are younger than 65 or those who have previously received systemic therapy for multiple myeloma may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment tolerability and outcomes for elderly patients with multiple myeloma.
How similar studies have performed: While the concept of dynamic frailty-tailored therapy is novel, there is emerging evidence suggesting that personalized treatment approaches can improve outcomes in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Changchun, Jilin
- The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.