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

Multiple Myeloma Clinical Trial

— DFA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06099912
• Other study ID #: Dynamic Frailty Assessment
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: July 1, 2027

Study information

• Verified date: June 2024
• Source: The First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

A retrospective study from our center demonstrated that frailty is an important prognostic factor in elderly NDMM patients and is independent of age and myeloma biology with the ability to predict OS and EM. However, this retrospective study had missing patient baseline data and some patients did not receive standardized induction therapy. Therefore, based on the previous study, investigators designed a present prospective, multicenter, single-arm, observational clinical study. Based on the IMWG frailty score, this study incorporated the Karnofsky Performance Status Scale (KPS) , the Mini-Nutritional Assessment Short-form (MNA-SF) , the 15-item Geriatric Depression Scale (GDS-15) , walking speed, and objective biological indicators including NT-pro-BNP, CRP, and eGFR , a comprehensive geriatric assessment of elderly NDMM patients, and an analysis of the clinical characteristics of frail and elderly patients with multiple myeloma， with the aim of establishing a new and better geriatric and frailty assessment system for identifying frail patients and validating its predictive efficacy for survival in elderly NDMM patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Adult males and females aged 65 years or above;
• 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;
• 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.

Related Conditions & MeSH terms

• Frailty
• Multiple Myeloma
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
FengYan Jin

References & Publications (18)

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Cardoso AL, Fernandes A, Aguilar-Pimentel JA, de Angelis MH, Guedes JR, Brito MA, Ortolano S, Pani G, Athanasopoulou S, Gonos ES, Schosserer M, Grillari J, Peterson P, Tuna BG, Dogan S, Meyer A, van Os R, Trendelenburg AU. Towards frailty biomarkers: Candidates from genes and pathways regulated in aging and age-related diseases. Ageing Res Rev. 2018 Nov;47:214-277. doi: 10.1016/j.arr.2018.07.004. Epub 2018 Jul 30. — View Citation

Coulson AB, Royle KL, Pawlyn C, Cairns DA, Hockaday A, Bird J, Bowcock S, Kaiser M, de Tute R, Rabin N, Boyd K, Jones J, Parrish C, Gardner H, Meads D, Dawkins B, Olivier C, Henderson R, Best P, Owen R, Jenner M, Kishore B, Drayson M, Jackson G, Cook G. Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma (FiTNEss (UK-MRA Myeloma XIV Trial)): a study protocol for a randomised phase III trial. BMJ Open. 2022 Jun 2;12(6):e056147. doi: 10.1136/bmjopen-2021-056147. — View Citation

Encinas C, Hernandez-Rivas JA, Oriol A, Rosinol L, Blanchard MJ, Bellon JM, Garcia-Sanz R, de la Rubia J, de la Guia AL, Jimenez-Ubieto A, Jarque I, Inigo B, Dourdil V, de Arriba F, Perez-Avila CC, Gonzalez Y, Hernandez MT, Bargay J, Granell M, Rodriguez-Otero P, Silvent M, Cabrera C, Rios R, Alegre A, Gironella M, Gonzalez MS, Sureda A, Sampol A, Ocio EM, Krsnik I, Garcia A, Garcia-Mateo A, Soler JA, Martin J, Arguinano JM, Mateos MV, Blade J, San-Miguel JF, Lahuerta JJ, Martinez-Lopez J; GEM/PETHEMA (Grupo Espanol de Mieloma/Programa para el Estudio de la Terapeutica en Hemopatias Malignas) cooperative study group. A simple score to predict early severe infections in patients with newly diagnosed multiple myeloma. Blood Cancer J. 2022 Apr 19;12(4):68. doi: 10.1038/s41408-022-00652-2. — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Through study completion, up to 24 months.
Other	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.	Through study completion, up to 24 months.
Other	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	Through study completion, up to 24 months.
Other	Discovery and identification of frailty biomarkers in elderly newly diagnosed multiple myeloma	Discovery and identification of frailty biomarkers in elderly newly diagnosed multiple myeloma.	Through study completion, up to 24 months.
Other	To explore the prognostic significance of blood liquid biopsy based on platelet RNA sequencing for multiple myeloma	Heterogeneity of disease as assessed by platelet RNA sequencing to explore the prognostic significance of blood liquid biopsy based on for multiple myeloma.	Through study completion, up to 24 months.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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.