NCT07107529招募中2 期
EFfIcacy and Tolerability of FIXed Duration Teclistamab and Talquetamab FOR FRAIL Patients With Newly Diagnosed Multiple Myeloma (2 Cohort Study) - the EMN 37 FITFIX FOR FRAIL Trial
European Myeloma Network B.V.29 个研究点 分布在 4 个国家目标入组 150 人开始时间: 2025年12月12日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 29
- 主要终点
- Progression Free Survival (PFS) per IMWG criteria
研究概览
简要总结
This is a multicenter, open-label phase II study with 2 parallel cohorts for frail patients with newly diagnosed multiple myeloma treated with daratumumab in combination with teclistamab and talquetamab.
The main purpose of this study is to determine the progression free survival at 18 months in patients treated with teclistamab and daratumumab (Cohort 1) or talquetamab and daratumumab (Cohort 2).
详细描述
This study will consist of 4 phases:
- Initial treatment phase where patients will receive fixed duration of Tec-Dara or Tal-Dara.
- TFI.
- Re-treatment phase, where patients with confirmed PD will continue treatment with Tec-Dara or Tal-Dara per their assignment in the initial treatment phase.
- Post-treatment follow-up phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥18 years of age and capable of giving informed consent and must sign an informed consent form (ICF), indicating that they understand the purpose of, and procedures required for, the study and is willing to participate in the study
- •Newly diagnosed and treatment-naïve patients with a confirmed diagnosis of MM with measurable disease according to IMWG criteria
- •Measurable disease defined as M-protein in the serum (≥1 g/dL) or serum free light chain assay ≥10 mg/dL [≥100 mg/L] and abnormal serum immunoglobulin kappa/lambda FLC ratio
- •Frail according to the Simplified IMWG frailty index
- •Have clinical laboratory values meeting defined range
- •Patients of childbearing potential must agree to use adequate/highly effective contraception from the time of signing the informed consent form through 3 months after the last dose of study drug
排除标准
- •Non-secretory MM or measurable disease by urine or plasmacytoma only
- •Central nervous system involvement of myeloma
- •Significant pulmonary dysfunction
- •Stroke, transient ischemic attack, or seizure within 6 months of eligibility
- •Evidence of active systemic viral, fungal, or bacterial infections, requiring systemic antimicrobial therapy
- •HIV and Hepatitis infections
- •Exclude for any of the following:
- •Any history of malignancy other than MM which is considered at high risk of recurrence requiring treatment or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity.
- •Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma.
- •Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before eligibility
- •Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study treatment or its excipients (refer to IB and most recently applicable RSI)
- •Extensive radiotherapy within 14 days or focal radiation only within 7 days of eligibility
- •Current or active therapy for multiple myeloma or received a cumulative dose corticosteroids equivalent to >40 mg dexamethasone within the 14 days prior to C1D1
- •Received a live attenuated vaccine ≤4 weeks before eligibility. Non-live vaccines or non-replicating authorized for emergency use (eg, COVID-19) are allowed
- •Received a strong CYP3A4 inducer or use of St. John's wort ≤5 half-lives prior to dosing
- •Patient had major surgery or significant traumatic injury within 2 weeks prior to eligibility. Kyphoplasty or Vertebroplasty is not considered major surgery
- •Have received an investigational drug (including investigation vaccines) or used an invasive investigational medical device <4 week or 5 PK half-lives, before eligibility or is currently enrolled in an interventional investigational study except if only long-term survival data are collected
- •Concurrent medical or psychiatric condition or disease (eg, uncontrolled diabetes, alcohol or drug abuse, severe dementia or altered mental status), that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participation in the study
- •Any other issue that would impair the ability of the patient to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (eg,, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
研究组 & 干预措施
Cohort 1
Experimental
Tec-Dara
干预措施: Teclistamab (Drug)
Cohort 1
Experimental
Tec-Dara
干预措施: Daratumumab (Drug)
Cohort 2
Experimental
Tal-Dara
干预措施: Talquetamab (Drug)
Cohort 2
Experimental
Tal-Dara
干预措施: Daratumumab (Drug)
结局指标
主要结局
Progression Free Survival (PFS) per IMWG criteria
时间窗: 18 months
defined as the time from the date of randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, where disease progression is determined per IMWG criteria.
次要结局
- Discontinuation(9 years)
- Change from Baseline in Health-Related Quality of Life as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score(Up to 9 years)
- Sustained Minimal Residual Disease (MRD) negative CR(9 years)
- IMWG best response(18 months)
- Time to response(9 years)
- Progression Free Survival 2 (PFS2)(9 years)
- Time to Next Treatment (TNT)(9 years)
- Adverse Events(9 years)
- Change from Baseline in Health-Related Quality of Life as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Myeloma 20 (EORTC-MY-20) Scale Score(Up to 9 years)
- Change from Baseline in Health-Related Quality of Life as Assessed by Instrumental Activities of Daily Living (IADL) questionnaire(Up to 9 years)
- Change from Baseline in Health-Related Quality of Life as Assessed by Scale of Subjective Total Taste Acuity (STTA)(Up to 9 years)
- Change from Baseline in the geriatric assessment as Assessed by Mini Nutritional Assessment (MNA) questionnaire(Up to 9 years)
- Change from Baseline in the geriatric assessment as Assessed by Mini-Mental State Examination (MMSE)(Up to 9 years)
- Overall Survival (OS)(9 years)
- Minimal Residual Disease (MRD) negative CR(18 months)
- Progression Free Survival 2 (PFS2)(9 years)
- Time to Next Treatment (TNT)(9 years)
- Change from Baseline in Health-Related Quality of Life as Assessed by Activities of Daily Living (ADL) questionnaire(Up to 9 years)
- Change from Baseline in Health-Related Quality of Life as Assessed by Scale of Subjective Total Taste Acuity (STTA)(Up to 9 years)
- Change from Baseline in the geriatric assessment as Assessed by Geriatric Assessment in Hematology (GAH) scale(Up to 9 years)
- Minimal Residual Disease (MRD) negativity rate(18 months)
- Sustained Minimal Residual Disease (MRD) negative CR(9 years)
- Discontinuation(9 years)
- Change from Baseline in Health-Related Quality of Life as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score(Up to 9 years)
- Change from Baseline in Health-Related Quality of Life as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Myeloma 20 (EORTC-MY-20) Scale Score(Up to 9 years)
- Change from Baseline in the geriatric assessment as Assessed by Geriatric Depression Scale (GDS)(Up to 9 years)
- Change from Baseline in the geriatric assessment as Assessed by Mini Nutritional Assessment (MNA) questionnaire(Up to 9 years)
- IMWG best response(18 months)
- Time to response(9 years)
- Time to best response(9 years)
- Event free survival (EFS)(9 years)
- Adverse Events(9 years)
- Change from Baseline in Health-Related Quality of Life as Assessed by Instrumental Activities of Daily Living (IADL) questionnaire(Up to 9 years)
- Change from Baseline in the geriatric assessment as Assessed by Mini-Mental State Examination (MMSE)(Up to 9 years)
研究者
研究点 (29)
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