2024-520433-76-00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., Emn Trial Office S.r.l. Impresa Sociale27 个研究点 分布在 4 个国家目标入组 150 人开始时间: 2025年10月20日最近更新:
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
- 27
- 主要终点
- PFS at 18 months, defined as the duration from the date of randomization to first documented PD, or death, whichever occurs first.
研究概览
简要总结
To determine the PFS at 18 months in patients treated with Tec-Dara (Cohort 1) or Tal-Dara (Cohort 2)
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomized, open-label phase II trial with 2 parallel cohorts
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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 the following criteria (see protocol)
- •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
- •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 C1D
- •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.
- •Central nervous system involvement of myeloma or presence of the following heart conditions: a. Severe cardiac dysfunction (NYHA classification III-IV) b. Myocardial infarction, unstable angina, or coronary artery bypass graft ≤6 months prior to eligibility c. History of clinically significant ventricular arrhythmia d. Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities e. Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia’s formula (QTcF) >500 msec f. Screening ECHO or MUGA: left ventricular ejection fraction (LVEF) <35%
- •Significant pulmonary dysfunction defined as: a. Acute diffuse infiltrative pulmonary disease. b. COPD with Forced Expiratory Volume in 1 second (FEV1) <50% of predicted normal or diffusing capacity of the lungs for carbon monoxide [DLCO] <50%. (Note that FEV1 testing is required for patients suspected of having COPD and patients must be excluded if FEV1<50 of predicted normal). c. Moderate or severe persistent asthma within the past 2 years or currently uncontrolled asthma of any classification. (Note that patients who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study).
- •Stroke, transient ischemic attack, or seizure within 6 months of eligibility.
- •Evidence of active systemic viral, fungal, or bacterial infections, requiring systemic antimicrobial therapy.
- •Any of the following infections: a. Seropositive for Human Immunodeficiency Virus (HIV). b. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). c. Seropositive for hepatitis C (anti-HCV antibody positive or HCV-RNA quantitation positive).
- •Exclude for any of the following: a. 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. b. Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured: i. Non-muscle invasive bladder cancer (solitary Ta-PUN-LMP or low grade, <3 cm, no CIS) ii. Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone iii. Non-invasive cervical cancer iv. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ or history of localized breast cancer (anti-hormonal therapy is permitted) v. Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP/RT/focal treatment) vi. Other malignancy that is considered cured with minimal risk of recurrence in consultation with the sponsor’s medical monitor.
- •Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before eligibility. Exception: a. Vitiligo not on systemic therapy b. Controlled Type 1 diabetes c. Prior autoimmune thyroid disease that is currently euthyroid based on clinical symptoms and laboratory testing
- •Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study treatment or its excipients (refer to IB and most recently applicable RSI).
结局指标
主要结局
PFS at 18 months, defined as the duration from the date of randomization to first documented PD, or death, whichever occurs first.
PFS at 18 months, defined as the duration from the date of randomization to first documented PD, or death, whichever occurs first.
次要结局
- Secondary efficacy endpoints: ● PFS ● OS ● MRD negativity rate at 18 months and over time ● MRD-negative CR at 18 months and over time ● Sustained MRD-negative CR (≥12 months) ● Depth of response defined by the ORR and the rate of sCR, CR, VGPR and PR ● Time to partial response and time to best response ● EFS, with events defined as: PD, death, treatment discontinuation due to toxicity ● PFS2 from the date of randomization to 2nd PD or death, whichever comes first ● TNT
- ● Depth of response defined by the ORR (sCR, CR, VGPR and PR) after re-treatment ● MRD-negativity rate after re-treatment
- ● Incidence and severity of AEs during initial therapy, TFI and after restarting therapy ● Discontinuation rate due to treatment related toxicity during initial therapy and after restarting therapy, including overall discontinuation rate, discontinuation rate of daratumumab, teclistamab and talquetamab ● Causes of discontinuation of therapy during initial therapy and after restarting therapy ● Incidence, grade and cause of infections [...] (for more information, refer to the protocol)
研究者
Prof. Dr. Sonja Zweegman
Scientific
European Myeloma Network B.V.
研究点 (27)
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