EUCTR2006-001865-41-BE进行中（未招募）1 期
A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled, 3-Arm Parallel Group Study to Determine the Efficacy and Safety of Lenalidomide (Revlimid) in Combination with Melphalan and Prednisone Versus Placebo Plus Melphalan and Prednisone in Subjects with Newly Diagnosed Multiple Myeloma Who Are 65 Years of Age or Older
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
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. Must understand and voluntarily sign an informed consent form
- •2. Age equal to or greater than 65 years at the time of signing the informed consent
- •3. Newly diagnosed with symptomatic multiple myeloma as defined by the 3 criteria below:
- •MM diagnostic criteria (all 3 required)
- •Monoclonal plasma cells in the bone marrow =10% and/or presence of a biopsy proven plasmacytoma
- •Monoclonal protein present in the serum and/or urine
- •Myeloma-related organ dysfunction
- •AND have measurable disease as defined by the following;
- •IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level = 1.0 g/dL or urine M-protein level = 200 mg/24 hours
- •IgA multiple myeloma: Serum M-protein level = 0.5 g/dL or urine M-protein level = 200 mg/24 hours
- •IgD multiple myeloma: Serum M-protein level = 0.05 g/dL or urine M-protein level = 200 mg/24 hours
- •Light chain multiple myeloma: Serum M-protein level = 1.0 g/dL or urine M-protein level = 200 mg/24 hours
- •IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level = 1.0g/dL or urine M-protein level =200mg/24hours
- •4. Karnofsky performance status = 60%.
- •5. Able to adhere to the study visit schedule and other protocol requirements.
- •6. Women of childbearing potential (WCBP) must:
- •a. Have a negative medically supervised pregnancy test prior to start of study
- •therapy. She must agree to ongoing pregnancy testing during the course of the
- •study, and after end of study therapy. This applies even if the subject practices complete and continued sexual abstinence.
- •b. Either commit to continued abstinence from heterosexual intercourse (which must
- •be reviewed on a monthly basis) or agree to use, and be able to comply with,
- •effective contraception without interruption, 28 days prior to starting study drug,
- •during the study therapy (including dose interruptions), and for 28 days after
- •discontinuation of study therapy.
- •7. Male subjects must:
- •a. Agree to use a condom during sexual contact with a WCBP, even if they have had
- •a vasectomy, throughout study drug therapy, during any dose interruption and
- •after cessation of study therapy.
- •b. Agree to not donate semen during study drug therapy and for a period after end of study drug therapy.
- •8. All subjects must:
- •a. Have an understanding that the study drug could have a potential teratogenic risk.
- •b. Agree to abstain from donating blood while taking study drug therapy and
- •following discontinuation of study drug therapy.
- •c. Agree not to share study medication with another person.
- •d. All patients must be counseled about pregnancy precautions and risks of fetal
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous treatment with antimyeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 28 days [4 weeks] of randomisation]).
- •2. Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds experimental the ability to interpret data from the study.
- •3. Pregnant or lactating females.
- •4. Radiotherapy within 14 days (2 weeks) of randomisation.
- •5. Plasmapheresis within 28 days (4 weeks) of randomisation.
- •6. Any of the following laboratory abnormalities:
- •Absolute neutrophil count (ANC) < 1,500 cells/µL (1.5 x 10.9/L)
- •Platelet count < 75,000/µL (75 x 10.9/L) for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; but platelet count <30,000/mcrL for subjects in whom = 50% of bone marrow nucleated cells are plasma cells
- •Haemoglobin < 8.0 g/dL (80 g/L)
- •Serum creatinine > 2.5 mg/dL (221 µmol/L)
- •Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
- •7. Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for = 3 years. Exceptions include the following:
- •Basal cell carcinoma of the skin
- •Squamous cell carcinoma of the skin
- •Carcinoma in situ of the cervix
- •Carcinoma in situ of the breast
- •Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
- •8. Neuropathy of = grade 2 severity.
- •9. Known HIV positivity or active infectious hepatitis, type A, B or C.
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