EUCTR2010-022253-42-DE进行中（未招募）不适用
An open, multicentric phase II trial to evaluate the efficacy and safety of Bendamustine, Lenalidomide (Revlimid®) and Dexamethasone (BRd) as 2nd-line therapy for patients with relapsed or refractory multiple myeloma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •Subjects must meet the following inclusion criteria to be eligible for the study:
- •- Written informed consent to be obtained before any study specific procedure
- •- Patients with first relapsed or refractory multiple myeloma (including patients with relapse after high dose chemotherapy followed by autologous stem cell transplantation) who have received no more than one prior anti-myeloma treatment line. Refractory myeloma is defined as relapse or disease progression while on first line therapy, or progression within 60 days after completion of 1st-line therapy.
- •- Treatment with a lenalidomide/ dexamethasone-based 2nd-line regimen is indicated and intended
- •- Measurable disease as defined by at least one of the following 3 measurements:
- •*serum monoclonal protein level = 1 g/dl (= 10 g/l) or
- •*urine M-protein level = 200 mg/24hours or
- •*serum FLC assay: Involved FLC level = 10 mg/dl (= 100 mg/l) provided serum FLC ratio is abnormal
- •- ECOG performance status 0, 1, or 2
- •- Age = 18 years
- •- All previous cancer therapy (except corticosteroid therapy), including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
- •- No prior treatment with a bendamustine containing regimen
- •- Prior treatment with lenalidomid is allowed if the treatment is completed > 12 months prior to study entry and the patient responded to prior lenalidomid treatment
- •- Adequate hematological values
- •- Adequate hepatic function
- •- Adequate renal function
- •- Disease free of prior malignancies for > 5 years unless the patient
- •o has been treated with a curative intent and is considered to be in complete remission for =2 years prior to study enrolment
- •o or has a curatively-treated
- •o basal cell/ squamous cell carcinoma of the skin,
- •o carcinoma „in situof the cervix,
- •o ductal breast carcinoma in situ with complete surgical resection(i.e. negative margins),
- •o medullary or papillary thyroid tumor
- •o or low grade, early stage localized prostate cancer treated surgically with curative intent
- •- Patient has the capability to understand the information given by the investigator on the trial
- •- Patient?s adherence to the protocol and geographic proximity to allow proper staging, treatment, and follow-up
- •- Female subjects of childbearing potential* must:
- •o understand that the study medication could have a potential teratogenic risk
- •o agree to fully comply with the mandatory pregnancy prevention programme as requested for the treatment with lenalidomide
- •o agree to use, and be able to comply with an effective, double-method contraception** without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. This applies also to females confirming abstinence to sexual intercourse.
- •o agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days prior to the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence. The test should ensure that the subject is not pregnant at start of treatment
- •- Male subjects must
- •o agree to use condoms throughout study drug therapy, during any dose interruption and for at least 6 months after cessation of study therapy with bendamustine and for at least one week after cess
排除标准
- •- Pregnant or breast feeding females
- •- Any prior use of bendamustine
- •- Patients who are unable or unwillingly to undergo antithrombotic therapy
- •- Any serious underlying medical condition (at the judgment of the investigator) which impairs the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric disorder)
- •- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she would participate in the study or any condition significantly confounding the ability to interpret data from the study, based on the local investigator?s judgment
- •- Severe cardiovascular disease, including myocardial infarction within 6 months before study entry, New York Heart Association Class III or IV heart failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias (= Lown 3)
- •- Use of any other experimental drug or therapy /treatment in a clinical trial 30 days prior to trial entry
- •- Known hypersensitivity to study drug(s) or hypersensitivity to any other component of the study drugs
- •- Any major surgical procedure within 30 days prior to study therapy
- •- Any concurrent antineoplastic therapy with chemotherapeutic agents or biologic agents or radiation therapy
- •- Known chronic hepatitis B or C, known HIV infection
- •- Jaundice or any other severe damage of the liver parenchyma
- •- Any contraindication for the treatment with bendamustine, lenalidomide, dexamethasone and / or pegfilgrastim in accordance with the appropriate SmPCs
- •- Any other concomitant drugs contraindicated for the use together with the study drugs according to the national health authorities.
研究者
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