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治験 NCT07045727（対象：再発多発性骨髄腫、難治性多発性骨髄腫）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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メイヨー・クリニックPrehabilitation With Aerobic and Resistance Exercise for Improving Physical Fitness and Quality of Life Outcomes in Older Patients Undergoing CAR-T Therapy for Relapsed or Refractory Multiple Myeloma
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07045727 は 介入研究 臨床試験 で、再発多発性骨髄腫、難治性多発性骨髄腫 に関するものです。現在は 募集中 で、2025年8月18日 から開始しています。20 名の参加者 の募集が計画されています。この治験は メイヨー・クリニック によって主催され、2026年9月15日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月11日 です。
概要
This clinical trial evaluates whether prehabilitation with aerobic and resistance exercise improves physical fitness and quality of life outcomes in older patients planning to undergo chimeric antigen receptor (CAR)-T therapy for multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). CAR-T therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. Large numbers of the CAR-T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. While CAR-T therapy is commonly used to treat multiple myeloma, it can result in toxicities that lead to hospitalization, nerve and muscle impairment, and decreased physical function. Prehabilitation programs use targeted interventions to improve functional status prior to medical or surgical treatments. In this study, patients participate in personalized aerobic and resistance prehabilitation activities in the weeks leading up to their CAR-T infusion. This program may improve physical fitness and quality of life, both prior to and after CAR-T infusion, in older patients with relapsed or refractory multiple myeloma.
公式タイトル
Prehabilitation in Patients With Multiple Myeloma Receiving CAR-T Therapy
疾患／病気
再発多発性骨髄腫難治性多発性骨髄腫その他の研究識別子
- 25-001845
- NCI-2025-04165 (登録識別子) (CTRP (Clinical Trial Reporting Program))
- 25-001845 (その他の識別子) (Mayo Clinic Institutional Review Board)
主目的
支持療法
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Supportive care (aerobic and resistance training) Patients receive a personalized exercise plan and use the Connected mHealth app to participate in aerobic and resistance training, according to exercise guidelines and their personalized plan, for 6 weeks. Patients also receive health coaching check-in calls weekly for 6 weeks. Patients also undergo collection of blood and urine samples throughout the study. | 加速度計測 Ancillary studies 有酸素運動 Participate in aerobic training program 生体試料採取 Undergo collection of blood and urine samples 電子健康記録レビュー Ancillary studies 運動カウンセリング Receive health coaching check-in calls インターネットベースの介入 Use Connected mHealth app インタビュー Ancillary studies 身体能力検査 Ancillary studies レジスタンストレーニング Participate in resistance training program 調査管理 Ancillary studies Tailored Intervention Receive personalized exercise plan |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Enrollment rate | Enrollment rate will be evaluated as the number of patients eligible versus the number of patients enrolled. | Up to 1 year |
Retention rate | Retention rate will be evaluated as the proportion of enrolled patients who complete assessments at visit 2 (at 2 days prior to CAR-T infusion) and visit 3 (30 days post-CAR-T infusion). | Up to 30 days post-chimeric antigen receptor (CAR)-T infusion |
Program completion | Will be evaluated according to the completion of weekly phone calls, the frequency, intensity, and duration of exercise engagement, and accelerometer summary outcomes. The program will be considered feasible if there is \> 70% program completion, based on weekly phone calls. | Up to 30 days post-CAR-T infusion |
Incidence of adverse events | The program will be considered feasible if there are no serious adverse events due to the intervention. | Up to 30 days post-CAR-T infusion |
Patient satisfaction | Patient satisfaction will be determined using post-program satisfaction phone interviews. Qualitative interviews will be analyzed using thematic analysis. | Up to 30 days post-CAR-T infusion |
Change in muscle strength | Assessed as grip strength, as measured (in kg) by maximal force generated by forearm muscles using calibrated handheld dynamometer | Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3) |
Change in muscle mass | Assessed via SOZO by ImpediMed \[bioimpedance spectroscopy (BIS)\] and Positron Emission Tomography (PET) Computed Tomography (CT) CT scan images, obtained as part of the patient's usual care. | Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3) |
Change in physical performance | Assessed via short physical performance test (approximately 90 minutes) followed by wearing an activity monitor (Actigraph) for 7 days following each of 3 in-person physical assessments. Participants receive a postage-paid envelope to return the monitor after wearing it. | Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3) |
Change in quality of life - EORTC QLQ-C30 | Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, a 30-item questionnaire where 28 questions are answered on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, and 4= very much) and 2 two questions are answered on a scale of 1-7 (1= very poor and 7=excellent). Higher summary scores indicate better health related quality of life. | Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3) |
Change in physical activity - monitor | Assessed using Polar heart rate monitor with data collected through the Connected mHealth app. | Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3) |
Change in physical activity - RPE Scale | Assessed using patient self-reported Rate of Perceived Exertion (RPE) scale score within the Connected mHealth app after exercise: 1=very light activity; 2-3=light activity; 4-5=moderate activity; 7-8=vigorous activity; 9=very hard activity; and 10=maximal effort. | Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3) |
Changes in frailty status - IMWG-FI | Assessed using International Myeloma Working Group (IMWG) Frailty Index (FI) scores. The IMWG-FI assigns scores based on age, comorbidities, and the ability to perform activities of daily living (ADL) and instrumental activities of daily living (IADL). Patients are categorized as follows: Fit: Score of 0; Intermediate-fit: Score of 1; Frail: Score of 2 or higher. | Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3) |
Changes in frailty status - FP | The Fried frailty phenotype (FP) defines frailty as the presence of three or more of the following: unintentional weight loss ≥10 lb in previous year; self-reported exhaustion; weakness measured by grip strength; slow walking speed ;and low physical activity (less than 3 days of physical activity per week defined by the Department of Health Services \& Human Services). The presence of: 1) ≥3 criteria indicates frail status, 2) 1 or 2 criteria indicates intermediate or pre-frail status, and 3) 0 criteria indicates robust status. | Baseline (prior to the intervention; Visit 1); Post-intervention (two days prior to CAR-T infusion; Visit 2), Follow-up (Day 30 post CAR-T; Visit 3) |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
60 Years
対象性別
全て
- Multiple myeloma diagnosis
- Females and males ≥ 60 years of age
- Eastern Cooperative Oncology Group (ECOG) score of < 3
- Scheduled for a CAR T therapy transfusion
- Apheresis date at least 7 days prior to date of enrollment
- Primary hematologist attending physician clearance for exercise
- Females or males < 60 years of age
- Any hematological cancer other than multiple myeloma
- Evidence of an absolute contraindication [e.g., heart insufficiency > New York Heart Association (NYHA) III or uncertain arrhythmia; uncontrolled hypertension; reduced standing or walking ability for exercise]
- Other comorbidities that preclude participation in the exercise as deemed by physical therapist or physical medicine and rehabilitation (PM&R) physician
- Active infections, active bleeding disorders, and cytopenias at risk for further adverse events deemed by hematologist-oncologist
メイヨー・クリニック868 件のアクティブな治験を探索試験中央連絡先
連絡先: Clinical Trials Referral Office, 855-776-0015, [email protected]
1 1カ国の場所
Minnesota
Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States
Clinical Trials Referral Office, 連絡先, 855-776-0015, [email protected]
Nadine H. Abdallah, MD, 研究責任者
Diane K. Ehlers, PhD, 研究責任者
募集中