EUCTR2017-000555-10-NO进行中（未招募）1 期
Carfilzomib, Lenalidomide and Dexamethasone versus Lenalidomide and Dexamethasone in High- Risk Smoldering Multiple Myeloma: A Randomized Phase II Study. - HOVON 147 SMM/ EMN15
HOVON Foundation0 个研究点目标入组 81 人开始时间: 2019年3月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 81
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must have histologically or cytologically confirmed Smoldering Multiple Myeloma based on the 2014 International Myeloma Working Group Criteria:
- •o Serum M-protein =3 g/dl
- •Or urinary monoclonal protein >500 mg per 24 hours
- •And/or monoclonal bone marrow plasma cells =10-60 %
- •o Absence of CRAB symptoms and myeloma defining events.
- •Patients must have high risk Smoldering Multiple Myeloma based on the Mayo Clinic and/or the PETHEMA criteria
- •Measurable disease
- •Age >18 years
- •WHO/ECOG performance status <=2
- •Patients must have normal organ and marrow function
- •Calculated Creatinine Clearance = 50 ml/min
- •Females of childbearing potential must have a negative serum or urine pregnancy test within 10 - 14 days prior to entry and again within 24 hours of starting lenalidomide treatment
- •Patients must be willing and capable to use adequate contraception during and after the therapy (all men, all pre-menopausal women) Patients must be able to adhere to the requirements of the Lenalidomide Pregnancy Prevention Plan
- •Written informed consent
- •Patient is capable of giving informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 34
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 47
排除标准
- •Patients with symptomatic multiple myeloma (i.e. having myeloma
- •defining events)
- •Amyloid Light-chain (AL) amyloidosis
- •Patients who are receiving any other investigational agents.
- •Concurrent systemic treatment or prior therapy within 4 weeks for SMM
- •Treatment with corticosteroids for other indications is not permitted
- •Contraindication to any concomitant medication, including antivirals,
- •anticoagulation prophylaxis, tumor lysis prophylaxis, or hydration given prior to therapy
- •History of allergic reactions attributed to immunomodulatory agents and proteasome inhibitors
- •Hypersensitive reaction to active substances or any excipients of the IMPs
- •Uncontrolled hypertension or diabetes
- •Pregnant or lactating females
- •Significant cardiovascular disease with NYHA grade III or IV symptoms, or hypertrophic cardiomegaly, or restrictive cardiomegaly, or
- •myocardial infarction within 3 months prior to enrollment, or unstable angina, or unstable arrhythmia
- •Active hepatitis B or C infection
- •Known or suspected HIV infection
- •Incidence of gastrointestinal disease that would prevent absorption.
- •Patients with gastric or duodenal ulcers
- •Significant neuropathy =Grade 3 or grade 2 with pain within 14 days of enrollment
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.
- •History of other malignancy (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma) except if the patient has been free of symptoms and without active therapy during at least 5 years
- •Major surgery within 1 month prior to enrollment
- •Pre-existing pulmonary, cardiac or renal impairement that prevents hydration measures
- •Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up
研究者
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