EUCTR2006-001865-41-IE进行中（未招募）不适用
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
- 不适用
- 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 mg/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
- •4. Karnofsky performance status = 60%.
- •5. Able to adhere to the study visit schedule and other protocol requirements.
- •6. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual intercourse during the 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.
- •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 28 days (4 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.
研究者
相似试验
进行中（未招募）
1 期
A Trial to Assess the Safety and Efficacy of Emactuzumab versus Placebo in Patients with Giant Cell Tumours.Tenosynovial Giant Cell TumourMedDRA version: 21.1Level: LLTClassification code 10025564Term: Malignant giant cell tumorSystem Organ Class: 100000004864EUCTR2021-001716-29-ESSynOx Therapeutics Ltd160
进行中（未招募）
不适用
Evaluation of Ceftaroline Fosamil versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.complicated bacterial skin and soft tissue infectionsMedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-004013-16-ATAstraZeneca AB765
进行中（未招募）
不适用
Evaluation of Ceftaroline Fosamil versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.Complicated bacterial skin and soft tissue infectionsMedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-004013-16-GRAstraZeneca AB765
进行中（未招募）
1 期
A Trial to Assess the Safety and Efficacy of Emactuzumab versus Placebo in Patients with Giant Cell Tumours.EUCTR2021-001716-29-ATSynOx Therapeutics Ltd160
进行中（未招募）
不适用
Evaluation of Ceftaroline Fosamil versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.EUCTR2011-004013-16-ESAstraZeneca AB765