EUCTR2008-004083-39-DE进行中（未招募）1 期
The combination of Lenalidomide and Dexamethasone with or without intensification by high-dose Melphalan in the treatment of multiple myeloma
GMIHO Gesellschaft für Medizinische Innovation – Hämatologie und Onkologie mbH0 个研究点目标入组 348 人开始时间: 2009年4月15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
- 348
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 60-75 years.
- •3. Able to adhere to the study visit schedule and other protocol requirements.
- •4. Symptomatic multiple myeloma requiring therapy
- •5. Measurable monoclonal protein present in serum and/or urine
- •6. Monoclonal plasma cells in the bone marrow = 10% and/or biopsy-proven plasmacytoma
- •7. Myeloma-related organ dysfunction, at least one of
- •[C] Calcium elevation in the serum (> 11.5 mg/dL or > 2.65 mmol/l)
- •[R] Renal insufficiency (creatinine > 2mg/dL or > 173 µmol/l)
- •[A] Anemia (Hb < 10 g/dL or 2 g/dL < normal)
- •[B] Bone lesions or general osteoporosis
- •8. ECOG performance status of = 2 at time of randomization
- •9. Laboratory test results within these ranges within 1 week prior to
- •randomization/registration:
- •Absolute neutrophil count = 1.0x10e9/L
- •Platelet count = 75 x 10e9/L or in case of bone marrow infiltration with myeloma cells = 30x10e9/L
- •Total bilirubin = 2mg/dL
- •AST and ALT = 3xULN
- •10. Female subjects of childbearing potential must:
- •o Understand the study drug has a teratogenic risk to the unborn child
- •o Agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time
- •periods related to this study: 1) for at least 28 days before starting
- •lenalidomide; 2) while taking lenalidomide; 3) during dose
- •interruptions; and 4) for at least 28 days after last dose of
- •lenalidomide . The two methods of reliable contraception must
- •include one highly effective method and one additional effective
- •(barrier) method. The following are examples of highly effective and additional effective methods of contraception:
- •Examples of highly effective methods:
- •- Intrauterine device (IUD)
- •- Hormonal (birth control pills, injections, implants, levonorgestrel-releasing intrauterine System [IUS], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills [e.g.
- •desogestrel]))
- •- Tubal ligation
- •- Partner’s vasectomy
- •Examples of additional effective methods:
- •- Male condom
- •- Diaphragm
- •- Cervical Cap
- •o Agree to have two medically supervised negative pregnancy tests
- •(sensitivity of at least 25 mIU/mL) prior to starting lenalidomide. The
- •first pregnancy test must be performed within 10 to 14 days prior to
- •the start of lenalidomide and the second pregnancy test must be
- •performed within 24 hours prior to the start of lenalidomide. The
- •patient may not receive lenalidomide until the study doctor has
- •verified that the results of these pregnancy tests are negative. This
- •requirement also applies to women of childbearing potential who
- •practice complete and continued abstinence. The test should ensure the subject is not pregnant when she starts treatment.
- •o Agree to have a medically supervised pregnancy test weekly for the
- •first 28 days of study participation and then every 28 days while taking
- •lenalidomide, at study discontinuation, and at day 28 following the last dose of lenalidomide. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days of study participation and then every 14 days while taking lenalidomide, at study discontinuation, and at days 14 and 28 following the last dose of
- •lenalidomide.
- 另有 3 项未显示
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 lactating 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. Patient currently is enrolled in another clinical research study or has been enrolled
- •in such a study within 4 weeks before randomization and/or is receiving an investigational agent for any reason or has received such an agent
- •within 4 weeks before randomization/registration
- •5. Known hypersensitivity to thalidomide, dexamethasone, or melphalan
- •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, with the exception of radiotherapy to restricted areas
- •9. Known positive for HIV; active or chronic hepatitis A, B or C infection (including patients who are tested anti-HBc positive and/or HBsAg positive) - serological testing for hepatitis A, B, C required
- •10. Prior treatment with dexamethasone discontinued because of = grade 3
- •dexamethasone-related toxicity
- •11. Any prior chemotherapy with the exception of a short course of dexamethasone for symptom control
- •12. Immunotherapy or antibody therapy within 8 weeks before
- •randomization
- •13. Major surgery within 4 weeks before randomization
- •14. Renal failure requiring dialysis
- •15. Myocardial infarction within 6 months before randomization/registration, NYHA Class III or IV heart failure, uncontrolled angina, severe
- •uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
- •ischemia or active conduction system abnormalities
- •16. Severe pulmonary disease (diffusion capacity < 50% of normal)
- •17. Treatment for cancer other than multiple myeloma within 5 years before
- •randomization, with the exception of basal cell carcinoma or cervical
- •cancer in situ
- •18. Cardiac amyloidosis
- •19. Poorly controlled hypertension, diabetes mellitus, or other serious medical or
- •psychiatric illness that could potentially interfere with the completion of treatment
- •according to the protocol
- •20. Any systemic infection requiring treatment
- •21. Unability or unwillingness of the patient to receive antithrombotic prophylaxis
研究者
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