Evaluating the Impact of a 12-month Multi-Modal Lifestyle Management Intervention on Disease Relevant Biomarkers

Официальное название

Evaluating the Impact of a 12-month Multi-Modal Lifestyle Management Intervention on Disease Relevant Biomarkers Associated With Monoclonal Gammopathy of Unknown Significance (MGUS) and Smoldering Myeloma (SM): A Prospective Intervention Pilot Study

Обзор

A prospective, pilot study to assess the impact of a 12-month multi-focal lifestyle intervention on myeloma-relevant biomarkers in patients with MGUS or SM. The multimodal lifestyle intervention has six foci that patients will participate in over the course of one-year.

Подробное описание

Patients with a diagnosis of MGUS or SM who are willing and able to participate in this 12-month multimodal lifestyle approach. Eligible patients include those 18 years of age and older diagnosed with MGUS/SM, ECOG PS 0-2, absence of significant comorbidities, and ability to speak/read/understand English.

The multimodal lifestyle intervention has six foci: Positive cognition \[mindset\], Exercise/movement, Stress Reduction, Social Connection, Emotional Wellbeing, and Nutrition. All programming will take place online to maximize convenience/sustained participation.

Вмешательства

• Другое The Multimodal Lifestyle Intervention
  The multimodal lifestyle intervention has six foci: positive cognition, exercise/movement, stress reduction, social connection, emotional well-being, and nutrition

Первичные конечные точки

• Efficacy of multi-modal lifestyle intervention based on any of the 3 specified myeloma tumor burden biomarker surrogates [Срок оценки: At study entry, 4 months, 8 months, and up to 12 months]

Вторичные конечные точки (2)

• Patient Acceptability (engagement) of the Lifestyle Intervention [Срок оценки: At study entry, 4 months, 8 months, and up to 12 months]
• Patient Adherence (compliance) to the Lifestyle Intervention [Срок оценки: At study entry, 4 months, 8 months, and up to 12 months]

Критерии участия

Критерии включения

• Adults 18 years or older.
• Diagnosed with MGUS or SM based on commonly accepted criteria per the

International Multiple Myeloma Working Group (IMWG), defined as follows:

a. For a diagnosis of Smoldering Multiple Myeloma (SM), both criteria must be met: i. Serum monoclonal protein (IgG or IgA) ≥ 30g/L or urinary monoclonal protein ≥ 500mg per 24h and/or clonal bone marrow plasma cells 10-60% ii. Absence of myeloma-defining events or amyloidosis b. For a diagnosis of Non-IgM Monoclonal Gammopathy of Undetermined

Significance (MGUS):

i. Serum monoclonal protein <30g/L ii. Clonal bone marrow plasma cells <10% iii. Absence of end-organ damage such as hypercalcemia, renal insufficiency, anemia, and bone lesions (CRAB) or amyloidosis that can be attributed to the plasma cell proliferative disorder c. For a diagnosis of IgM MGUS: i. Serum IgM monoclonal protein <30g/L ii. No evidence of anemia, constitutional symptoms, hyperviscosity, lymphadenopathy, hepatosplenomegaly, or other end-organ damage that can be attributed to the plasma cell proliferative disorder d. For a diagnosis of light change MGUS: i. Abnormal FLC ratio (<0.26 or >1.65) ii. Increased level of the appropriate free light chain (increased κ FLC in patients with ratio >1.65 and increased λ FLC in patients with ratio <0.26) iii. No immunoglobulin heavy chain expression on immunofixation iv. Absence of end-organ damage such as hypercalcemia, renal insufficiency, anemia, and bone lesions (CRAB) or amyloidosis that can be attributed to the plasma cell proliferative disorder v. Clonal bone marrow plasma cells <10% vi. Urinary monoclonal protein <500mg/24h

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
• Ability to speak, read and comprehend the English language.
• Absence of significant intercurrent illness such as uncontrolled heart failure, unstable angina, cardiac arrhythmia and psychiatric illness which would preclude informed consent.
• Patient understands the purpose of the trial and procedures required for the trial, and can provide signed informed consent as which includes compliances with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.
• Ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and test specimen (blood sample) collection at specified time points.

Критерии исключения

• Evidence of any one or more of the following biomarkers of malignancy, or myeloma-defining events (MDEs) meeting IMWG criteria for a diagnosis of multiple myeloma:

• 60% or greater clonal plasma cells on bone marrow examination
• Serum involved / uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved light chain is at least 100mg/L (a patient's involved free light chain either kappa or lambda is the one that is above the normal reference range; the uninvolved free light chain is the one that is typically in, or below, the normal range)
• More than one focal lesion on MRI that is at least 5mm or greater in size.
• Evidence of end-organ damage as per the IMWG CRAB criteria, defined as follows:

• Hypercalcemia: serum calcium >0.25 mmol/L (>1mg/dL) higher than the upper limit of normal or >2.75 mmol/L (>11mg/dL)
• Renal insufficiency: creatinine clearance <40 mL per minute or serum creatinine >177mol/L (>2mg/dL)
• Anemia: hemoglobin value of >20g/L below the lowest limit of normal, or a hemoglobin value <100g/L
• Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET/CT. If bone marrow has <10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement
• Unwillingness or inability to follow required intervention behaviors, including any safety issues related to participating in any part of the intervention (e.g., a contraindication to gentle movement/exercise, BMI <18 kg/m2, etc.).
• Pregnancy or breastfeeding
• Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Mateos MV, Landgren O. MGUS and Smoldering Multiple Myeloma: Diagnosis and Epidemiology. Cancer Treat Res. 2016;169:3-12. doi: 10.1007/978-3-319-40320-5_1. PMID 27696254
• Plano F, Corsale AM, Gigliotta E, Camarda G, Vullo C, Di Simone M, Shekarkar Azgomi M, Speciale M, Carlisi M, Caccamo N, Dieli F, Meraviglia S, Siragusa S, Botta C. Monoclonal Gammopathies and the Bone Marrow Microenvironment: From Bench to Bedside and Then Back Again. Hematol Rep. 2023 Jan 9;15(1):23-49. doi: 10.3390/hematolrep15010004. PMID 36648882
• Padala SA, Barsouk A, Barsouk A, Rawla P, Vakiti A, Kolhe R, Kota V, Ajebo GH. Epidemiology, Staging, and Management of Multiple Myeloma. Med Sci (Basel). 2021 Jan 20;9(1):3. doi: 10.3390/medsci9010003. PMID 33498356
• Cancer.Org. Published 2012. Https://Www.Cancer.Org/Cancer/Multiple-Myeloma/Detectiondiagnosis-Staging/Surviva l-Rates.Html. Accessed January 19, 2023.
• Multiple Myeloma - Statistics. Cancer.Net. Published February 28, 2019. Https://Www.Cancer.Net/Cancer-Types/Multiple-Myeloma/Statistics. Accessed January 19, 2023.
• Kyle RA, Remstein ED, Therneau TM, Dispenzieri A, Kurtin PJ, Hodnefield JM, Larson DR, Plevak MF, Jelinek DF, Fonseca R, Melton LJ 3rd, Rajkumar SV. Clinical course and prognosis of smoldering (asymptomatic) multiple myeloma. N Engl J Med. 2007 Jun 21;356(25):2582-90. doi: 10.1056/NEJMoa070389. PMID 17582068
• Mateos MV, Kumar S, Dimopoulos MA, Gonzalez-Calle V, Kastritis E, Hajek R, De Larrea CF, Morgan GJ, Merlini G, Goldschmidt H, Geraldes C, Gozzetti A, Kyriakou C, Garderet L, Hansson M, Zamagni E, Fantl D, Leleu X, Kim BS, Esteves G, Ludwig H, Usmani S, Min CK, Qi M, Ukropec J, Weiss BM, Rajkumar SV, Durie BGM, San-Miguel J. International Myeloma Working Group risk stratification model for smolderi PMID 33067414
• Aljama MA, Sidiqi MH, Lakshman A, Dispenzieri A, Jevremovic D, Gertz MA, Lacy MQ, Buadi FK, Dingli D, Muchtar E, Fonder AL, Hayman SR, Hobbs MA, Gonsalves WI, Warsame R, Kourelis TV, Hwa YL, Kapoor P, Leung N, Go RS, Kyle RA, Rajkumar SV, Kumar SK. Plasma cell proliferative index is an independent predictor of progression in smoldering multiple myeloma. Blood Adv. 2018 Nov 27;2(22):3149-3154. doi: PMID 30463914

Идентификаторы

NCT: NCT06987708 · Pro2024-0235 · MGUS-SM-Lifestyle

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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