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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06099912
Other study ID # Dynamic Frailty Assessment
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
FengYan Jin

References & Publications (18)

Antoine-Pepeljugoski C, Braunstein MJ. Management of Newly Diagnosed Elderly Multiple Myeloma Patients. Curr Oncol Rep. 2019 May 24;21(7):64. doi: 10.1007/s11912-019-0804-4. — View Citation

Bringhen S, Mateos MV, Zweegman S, Larocca A, Falcone AP, Oriol A, Rossi D, Cavalli M, Wijermans P, Ria R, Offidani M, Lahuerta JJ, Liberati AM, Mina R, Callea V, Schaafsma M, Cerrato C, Marasca R, Franceschini L, Evangelista A, Teruel AI, van der Holt B, Montefusco V, Ciccone G, Boccadoro M, San Miguel J, Sonneveld P, Palumbo A. Age and organ damage correlate with poor survival in myeloma patients: meta-analysis of 1435 individual patient data from 4 randomized trials. Haematologica. 2013 Jun;98(6):980-7. doi: 10.3324/haematol.2012.075051. Epub 2013 Feb 26. — View Citation

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

Global Burden of Disease Cancer Collaboration; Fitzmaurice C, Abate D, Abbasi N, Abbastabar H, Abd-Allah F, Abdel-Rahman O, Abdelalim A, Abdoli A, Abdollahpour I, Abdulle ASM, Abebe ND, Abraha HN, Abu-Raddad LJ, Abualhasan A, Adedeji IA, Advani SM, Afarideh M, Afshari M, Aghaali M, Agius D, Agrawal S, Ahmadi A, Ahmadian E, Ahmadpour E, Ahmed MB, Akbari ME, Akinyemiju T, Al-Aly Z, AlAbdulKader AM, Alahdab F, Alam T, Alamene GM, Alemnew BTT, Alene KA, Alinia C, Alipour V, Aljunid SM, Bakeshei FA, Almadi MAH, Almasi-Hashiani A, Alsharif U, Alsowaidi S, Alvis-Guzman N, Amini E, Amini S, Amoako YA, Anbari Z, Anber NH, Andrei CL, Anjomshoa M, Ansari F, Ansariadi A, Appiah SCY, Arab-Zozani M, Arabloo J, Arefi Z, Aremu O, Areri HA, Artaman A, Asayesh H, Asfaw ET, Ashagre AF, Assadi R, Ataeinia B, Atalay HT, Ataro Z, Atique S, Ausloos M, Avila-Burgos L, Avokpaho EFGA, Awasthi A, Awoke N, Ayala Quintanilla BP, Ayanore MA, Ayele HT, Babaee E, Bacha U, Badawi A, Bagherzadeh M, Bagli E, 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F, Naldi L, Nam HS, Nasiri N, Nazari J, Negoi I, Neupane S, Newcomb PA, Nggada HA, Ngunjiri JW, Nguyen CT, Nikniaz L, Ningrum DNA, Nirayo YL, Nixon MR, Nnaji CA, Nojomi M, Nosratnejad S, Shiadeh MN, Obsa MS, Ofori-Asenso R, Ogbo FA, Oh IH, Olagunju AT, Olagunju TO, Oluwasanu MM, Omonisi AE, Onwujekwe OE, Oommen AM, Oren E, Ortega-Altamirano DDV, Ota E, Otstavnov SS, Owolabi MO, P A M, Padubidri JR, Pakhale S, Pakpour AH, Pana A, Park EK, Parsian H, Pashaei T, Patel S, Patil ST, Pennini A, Pereira DM, Piccinelli C, Pillay JD, Pirestani M, Pishgar F, Postma MJ, Pourjafar H, Pourmalek F, Pourshams A, Prakash S, Prasad N, Qorbani M, Rabiee M, Rabiee N, Radfar A, Rafiei A, Rahim F, Rahimi M, Rahman MA, Rajati F, Rana SM, Raoofi S, Rath GK, Rawaf DL, Rawaf S, Reiner RC, Renzaho AMN, Rezaei N, Rezapour A, Ribeiro AI, Ribeiro D, Ronfani L, Roro EM, Roshandel G, Rostami A, Saad RS, Sabbagh P, Sabour S, Saddik B, Safiri S, Sahebkar A, Salahshoor MR, Salehi F, Salem H, Salem MR, Salimzadeh H, 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Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2017: A Systematic Analysis for the Global Burden of Disease Study. JAMA Oncol. 2019 Dec 1;5(12):1749-1768. doi: 10.1001/jamaoncol.2019.2996. Erratum In: JAMA Oncol. 2020 Mar 1;6(3):444. JAMA Oncol. 2020 May 1;6(5):789. JAMA Oncol. 2021 Mar 1;7(3):466. — View Citation

Joao C, Geraldes C, Neves M, Mariz M, Trigo F. Management of older and frail patients with multiple myeloma in the Portuguese routine clinical practice: Deliberations and recommendations from an expert panel of hematologists. J Geriatr Oncol. 2020 Nov;11(8):1210-1216. doi: 10.1016/j.jgo.2020.06.002. Epub 2020 Jun 27. — View Citation

Kumar SK, Dispenzieri A, Lacy MQ, Gertz MA, Buadi FK, Pandey S, Kapoor P, Dingli D, Hayman SR, Leung N, Lust J, McCurdy A, Russell SJ, Zeldenrust SR, Kyle RA, Rajkumar SV. Continued improvement in survival in multiple myeloma: changes in early mortality and outcomes in older patients. Leukemia. 2014 May;28(5):1122-8. doi: 10.1038/leu.2013.313. Epub 2013 Oct 25. — View Citation

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Larocca A, Dold SM, Zweegman S, Terpos E, Wasch R, D'Agostino M, Scheubeck S, Goldschmidt H, Gay F, Cavo M, Ludwig H, Straka C, Bringhen S, Auner HW, Caers J, Gramatzki M, Offidani M, Dimopoulos MA, Einsele H, Boccadoro M, Sonneveld P, Engelhardt M. Patient-centered practice in elderly myeloma patients: an overview and consensus from the European Myeloma Network (EMN). Leukemia. 2018 Aug;32(8):1697-1712. doi: 10.1038/s41375-018-0142-9. Epub 2018 Apr 25. — View Citation

Mian H, Wildes TM, Vij R, Pianko MJ, Major A, Fiala MA. Dynamic frailty risk assessment among older adults with multiple myeloma: A population-based cohort study. Blood Cancer J. 2023 May 10;13(1):76. doi: 10.1038/s41408-023-00843-5. — View Citation

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Palumbo A, Avet-Loiseau H, Oliva S, Lokhorst HM, Goldschmidt H, Rosinol L, Richardson P, Caltagirone S, Lahuerta JJ, Facon T, Bringhen S, Gay F, Attal M, Passera R, Spencer A, Offidani M, Kumar S, Musto P, Lonial S, Petrucci MT, Orlowski RZ, Zamagni E, Morgan G, Dimopoulos MA, Durie BG, Anderson KC, Sonneveld P, San Miguel J, Cavo M, Rajkumar SV, Moreau P. Revised International Staging System for Multiple Myeloma: A Report From International Myeloma Working Group. J Clin Oncol. 2015 Sep 10;33(26):2863-9. doi: 10.1200/JCO.2015.61.2267. Epub 2015 Aug 3. — View Citation

Palumbo A, Bringhen S, Mateos MV, Larocca A, Facon T, Kumar SK, Offidani M, McCarthy P, Evangelista A, Lonial S, Zweegman S, Musto P, Terpos E, Belch A, Hajek R, Ludwig H, Stewart AK, Moreau P, Anderson K, Einsele H, Durie BG, Dimopoulos MA, Landgren O, San Miguel JF, Richardson P, Sonneveld P, Rajkumar SV. Geriatric assessment predicts survival and toxicities in elderly myeloma patients: an International Myeloma Working Group report. Blood. 2015 Mar 26;125(13):2068-74. doi: 10.1182/blood-2014-12-615187. Epub 2015 Jan 27. Erratum In: Blood. 2016 Mar 3;127(9):1213. Blood. 2016 Mar 3;127(9):1213. Blood. 2016 Aug 18;128(7):1020. — View Citation

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Stege CAM, Nasserinejad K, Klein SK, Timmers GJ, Hoogendoorn M, Ypma PF, Nijhof IS, Velders GA, Strobbe L, Durdu-Rayman N, Westerman M, Davidis-van Schoonhoven MA, van Kampen RJW, Beeker A, Koster A, Dijk AC, van de Donk NWCJ, van der Spek E, Leys RBL, Silbermann MH, Groen K, van der Burg-de Graauw NCHP, Sinnige HAM, van der Hem KG, Levenga H, Bilgin YM, Sonneveld P, Levin MD, Zweegman S. Improving the identification of frail elderly newly diagnosed multiple myeloma patients. Leukemia. 2021 Sep;35(9):2715-2719. doi: 10.1038/s41375-021-01162-z. Epub 2021 Feb 15. No abstract available. — View Citation

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* Note: There are 18 references in allClick 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.
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