EUCTR2007-006677-83-DE进行中（未招募）不适用
A Phase 1b/II, Multicenter, Open-Label, Dose-Escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Combination with Lenalidomide and Dexamethasone in Subjects with Relapsed Multiple Myeloma.Elotuzumab (formerly HuLuc63)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
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. Age 18 years or older with confirmed diagnosis of Multiple Myeloma (MM) and documentation of one to three prior therapies.
- •2. Confirmed evidence of disease progression from immediately prior MM therapy(see Appendix A - for the definition of disease progression) or refractory to the immediately prior treatment.
- •3. Measurable disease M-protein component in serum (at least 0.5 g/dL) and/or urine (if present =0.2 g excreted in a 24-hour collection sample). Subjects with light chain only disease are excluded.
- •4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- •5. Creatinine clearance =50 mL/min measured by Cockcroft-Gault.
- •6. Hematological parameters defined by:
- •Absolute neutrophil count >1000 cells/mm3 without growth factors for 7 days.
- •Platelets =75,000 cells/mm3 (75 × 109/L),
- •Hemoglobin =8 g/dL without red blood cell transfusion within 72 hours of screening.
- •7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <3 × upper limit of normal.
- •8. Total bilirubin <2 × upper limit of normal (ULN), direct bilirubin <2.0 mg/dL.
- •9. Negative urine pregnancy test in women of childbearing potential at screening and prior to prescribing lenalidomide. Females of childbearing potential (FCBP) must either commit to continued abstinence from heterosexual intercourse or begin acceptable methods of birth control for 28 days prior to prescribing lenalidomide. Men must agree to use a latex condom during sexual contact with FCBP even if they have had a successful vasectomy, and must agree not to donate semen during study drug therapy and for a period of time after therapy. See protocol Appendix L for United States of America (USA) requirements and Appendix M for all non-USA requirements, including the definition of FCBP.
- •10. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject’s privacy regulations).
- •11. Able to take aspirin daily as prophylactic anticoagulation therapy (subjects intolerant to aspirin may use warfarin or low molecular weight heparin).
- •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 of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •1. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease-free for at least 2 years.
- •2. Active or prior plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma / CD138+ cells or an absolute of 2*10^9/L)
- •3. Uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias, pulmonary disease, and symptomatic heart failure.
- •4. Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
- •5. Treatment with any investigational drug within 2 weeks or 3 half lives (whichever is longer) of the first dose of elotuzumab.
- •6. Use of therapeutic corticosteroids, thalidomide, bortezomib, or cytotoxic chemotherapy within 2 weeks of the first dose of elotuzumab except for steroids with to no systemic absorption (ie, topical or inhaled steroids).
- •7. Prior lenalidomide therapy.
- •8. Prior peripheral stem cell transplant within 12 weeks of the first dose of elotuzumab.
- •9. Treatment with nitrosoureas, such as BiCNU (carmustine), nitrogen mustard agents, or melphalan, within 6 weeks of first dose of elotuzumab.
- •10. Neuropathy =Grade 3 or painful neuropathy =Grade 2 (National Cancer Institute Common Terminology Criteria of Adverse Events [NCI CTCAE] v3.0).
- •11. Known active infections requiring IV antibiotic, antiviral, or antifungal therapy.
- •12. Hypersensitivity to recombinant proteins or excipients in elotuzumab, lenalidomide, or dexamethasone.
- •13. Female subjects who are pregnant or breastfeeding.
- •14. Subjects with serum calcium (corrected albumin) = 12 mg/dL
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