EUCTR2008-001885-96-DE进行中（未招募）1 期
Treatment with Lenalidomide, Bendamustine and Prednisone (RBP) in Patients with Relapsed or Refractory Multiple Myeloma after Autologous Stem Cell Transplantation or Conventional Chemotherapy OSHO #077 - OSHO #077
niversity of Leipzig0 个研究点目标入组 50 人开始时间: 2009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
- 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
- •1.Understand and voluntarily sign an informed consent form.
- •2.Age =18 years at the time of signing the informed consent form.
- •3.Life expectancy of at least 3 months
- •4.Able to adhere to the study visit schedule and other protocol requirements.
- •5.Relapsed or refractory MM (only first or second relapse) in stage II or III after autologous SCT or conventional chemotherapy (histological or cytological proven/ Salmon and Durie criteria) with detectable myeloma protein in blood or urine
- •6.All previous cancer therapy, including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, without corticosteroids therapy.
- •7.ECOG performance status of = 2 at study entry.
- •8.Laboratory test results within these ranges:
- •Absolute neutrophil count = 1.5 x 10 9/L
- •Platelet count = 100 x 109/L
- •GFR = 50 ml/min
- •Total bilirubin = 1.5 mg/dl
- •AST (SGOT) and ALT (SGPT) = 2 x ULN or = 5 x ULN if hepatic metastases are present.
- •9.Disease free of prior malignancies for = 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma insitu” of the cervix or breast
- •10.Female subjects of childbearing potential must:
- •o Understand that the study medication could have a potential teratogenic risk
- •o Agree to use, and be able to comply with, effective 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 unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception
- •?Levonorgestrel-releasing intrauterine system (IUS)
- •?Medroxyprogesterone acetate depot
- •?Tubal sterilisation
- •?Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
- •?Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
- •o Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days from 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.
- •o Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
- •Male subjects must
- •o Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
- •o Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
- •All subjects must
- •o Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
- •o Agree not to share study medication with another person and to return all unused study drug to the investigator
- •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
排除标准
- •1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •2. Pregnant or breast feeding females.
- •3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •4. Patients with contraindications (exclusion criteria) for treatment with lenalidomide, bendamustine and prednisone.
- •5. Uncontrolled or 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).
- •6. Use of any other experimental drug or therapy within 28 days of baseline.
- •7. Known hypersensitivity to thalidomide or purine analogues
- •8. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- •9. Any prior use of lenalidomide or bendamustine in the last six months
- •10. Concurrent use of other anti-cancer agents or treatments other than those stated in this treatment plan.
- •11. Known positive for HIV or infectious hepatitis, type A, B or C.
研究者
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