ACTRN12613000344796进行中（未招募）2 期
A Phase II Study of Lenalidomide Induction, Autologous Peripheral Stem Cell Transplant and Adjuvant Vaccination with Autologous Dendritic Cells and Lenalidomide Maintenance in Multiple Myeloma.
Peter MacCallum Cancer Centre0 个研究点目标入组 42 人开始时间: 2013年3月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.The patient has a bone marrow biopsy confirmed diagnosis of multiple myeloma (MM)
- •2.Understand and voluntarily sign an informed consent form.
- •3.Age 18 years or over at the time of signing the informed consent form.
- •4.Able to adhere to the study visit schedule and other protocol requirements.
- •5.The diagnostic marrow demonstrates >50% plasmacytosis on immunohistology with anti-CD138 in the 1st 2 cohorts of patients. For the additional cohorts of newly diagnosed patients, <50% plasma cell infiltrate is permitted.
- •6.Patient is eligible (on normal disease and performance status criteria) for autologous SCT
- •7.All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study. Under exceptional circumstances and only with the specific permission of the PI, a single course of Dexamethasone 20mg/day x4 days (or equivalent) is allowed in the 4 weeks prior to the start of therapy.
- •8.Should have measurable disease as per Blade/ EBMT criteria.
- •9.ECOG performance status of less than or equal to 2 at study entry.
- •10.Laboratory test results within these ranges:
- •Absolute neutrophil count greater than or equal to 1.5 x 109/L
- •Platelet count greater than or equal to 100 x 109/L
- •Serum creatinine less than or equal to 2.0 mg/dL
- •Total bilirubin less than or equal to 1.5 mg/dL
- •11.Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner’s vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.
- •Before starting study drug:
- •Female Subjects:
- •a. FCBP must have two negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug. The first pregnancy test must be performed within 10-14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to the start of study drug. The subject may not receive study drug until the Investigator has verified that the results of these pregnancy tests are negative.
- •b. Will be warned that sharing study drug is prohibited and will be counselled about pregnancy precautions and potential risks of foetal exposure.
- •c. Must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from the study.
- •Male Subjects:
- •d. Must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy.
- •e. Will be warned that sharing study drug is prohibited and will be counselled about pregnancy precautions and potential risks of foetal exposure.
- •f. Must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation fr
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. (Lactating females must agree not to breast feed while taking lenalidomide).
- •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.Use of any other experimental drug or therapy within 28 days of baseline.
- •5.Known hypersensitivity to thalidomide.
- •6.The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- •7.Any prior use of lenalidomide.
- •8.Concurrent use of other anti-cancer agents or treatments.
- •9.Known positive for HIV or infectious hepatitis, type A, B or C.
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