NL-OMON53146招募中2 期
Carfilzomib, Lenalidomide and Dexamethasone versus Lenalidomide and Dexamethasone in High- Risk Smoldering Multiple Myeloma: A Randomized Phase 2 Study - HOVON 147 SMM
HOVO0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
排除标准
- •Patients with symptomatic multiple myeloma (i.e. having myeloma defining
- •Amyloid Light-chain (AL) amyloidosis
- •Patients who are receiving any other investigational agents.
- •Concurrent systemic treatment or prior therapy within 4 weeks for SMM
- •Contraindication to any concomitant medication, including antivirals,
- •anticoagulation prophylaxis, tumor lysis prophylaxis, or hydration given prior
- •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
- •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
- •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
- •Any psychological, familial, sociological and geographical condition
- •potentially hampering compliance with the study protocol and follow-up schedule
研究者
相似试验
进行中（未招募）
1 期
Carfilzomib, Lenalidomide and Dexamethasone versus Lenalidomide and Dexamethasone in High- Risk Smoldering Multiple Myeloma.Smoldering multiple myelomaMedDRA version: 26.1Level: LLTClassification code 10075894Term: Smoldering myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-000555-10-NOHOVON Foundation81
进行中（未招募）
1 期
Carfilzomib, Lenalidomide and Dexamethasone versus Lenalidomide and Dexamethasone in High- Risk Smoldering Multiple Myeloma.Smoldering multiple myelomaMedDRA version: 26.1Level: LLTClassification code 10075894Term: Smoldering myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-000555-10-NLHOVON Foundation81
进行中（未招募）
1 期
Carfilzomib, Lenalidomide and Dexamethasone versus Lenalidomide and Dexamethasone in High- Risk Smoldering Multiple Myeloma.Smoldering multiple myelomaMedDRA version: 20.0Level: LLTClassification code 10075894Term: Smoldering myelomaSystem Organ Class: 100000004864EUCTR2017-000555-10-ITHOVO120
进行中（未招募）
1 期
Carfilzomib, Lenalidomide and Dexamethasone versus Lenalidomide and Dexamethasone in High- Risk Smoldering Multiple Myeloma.Smoldering multiple myelomaMedDRA version: 20.0Level: LLTClassification code 10075894Term: Smoldering myelomaSystem Organ Class: 100000004864EUCTR2017-000555-10-CZHOVON Foundation120
进行中（未招募）
1 期
Carfilzomib + Lenalidomide +Dexamethasone for BTK inhibitors relapsed-refractory or intolerant mantle cell lymphomasBTK inhibitors relapsed-refractory or intolerant mantle cell lymphomasMedDRA version: 20.0Level: PTClassification code 10061275Term: Mantle cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-000540-25-ITFONDAZIONE ITALIANA LINFOMI ONLUS59