EUCTR2006-001904-36-GR进行中（未招募）1 期
A Phase 2, Randomized, Double-blind, Placebo-controlled Study Comparing the Combination of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and Velcade® versus Velcade alone in Subjects with Relapsed or Refractory Multiple Myeloma
Centocor B.V.0 个研究点目标入组 290 人开始时间: 2007年11月20日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 290
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
- •To be eligible for the study, subjects must meet all of the following criteria:
- •1. Male or female age = 18 years
- •2. Signed informed consent obtained prior to any study-specific screening procedures
- •3. Confirmed diagnosis of multiple myeloma
- •4. Measurable secretory disease defined as either serum monoclonal paraprotein, (M-protein) =1 g/dL or urine monoclonal (light chain) protein (> 200 mg/24 hours)
- •5. Documented disease progression (according to EBMT criteria) after at least 1 prior line of therapy but no more than 3 or have had no response to previous treatment (primary refractory disease)
- •a. A single line of therapy may consist of 1 or more drugs such as, melphalan plus prednisone; vincristine plus conventional doxorubicin (or Doxil/Caelyx) plus dexamethasone (VAD/DVd); lenalidomide; or high-dose pulse corticosteroid with or without thalidomide (rituximab alone or experimental agents alone should not be considered a line of therapy)
- •b. A single line of therapy may include induction chemotherapy followed by hematopoietic stem cell transplantation and maintenance therapy or progression of disease before a response during the initial line of therapy (primary refractory disease) with a regimen that may have contained an anthracycline, an alkylating agent, or high-dose corticosteroids (rituximab alone or experimental agents alone should not be considered a line of therapy
- •6. ECOG performance status score of =2
- •7. Subjects experiencing toxicities resulting from previous therapy must have fully recovered or stabilized to = Grade 1
- •8. Subjects of childbearing potential must use adequate birth control measures. Female subjects of childbearing potential must have a negative serum pregnancy test at screening
- •9. Adequate bone marrow, liver, and renal function at first dose/randomization as described below:
- •a. Hemoglobin = 7.5 g/dL (4.7 mmol/L; 75 g/L) with or without transfusion dependency
- •b. Platelets = 50,000/mm3 without transfusion dependency
- •c. Absolute neutrophil count (ANC) = 1000 mm3 without hematopoietic cytokine support
- •d. AST, ALT, and alkaline phosphatase = 3 x ULN
- •e. Bilirubin = 2 x ULN
- •f. Calculated creatinine clearance = 30 mL/min
- •g. Corrected serum calcium < 12 mg/dL (3.0 mmol/L) or ionized calcium < 6.5 mg/dL (1.6 mmol/L). This level may be achieved by treatment but it must be reached before the subject is randomized
- •10. Able to adhere to study visit schedule and all protocol requirements
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects meeting any of the following criteria may not be enrolled in the study:
- •1. Prior treatment with bortezomib
- •2. Hypersensitivity or allergic reactions to boron or mannitol, or compounds containing these components
- •3. Refractory to high-dose dexamethasone defined by less than PR, or progressive disease within 6 to 12 months of achieving a response, or discontinuation of the drug due to = Grade 3 dexamethasone-related AEs. High-dose dexamethasone is defined as receiving > 500 mg over a 10-week period (alone or in combination)
- •4. = Grade 2 peripheral neuropathy (according to NCI CTCAE, Version 3.0)
- •5. Treatment with systemic cancer therapy (including clarithromycin) or radiotherapy within 30 days of randomization
- •6. Treatment with nitrosoureas within 42 days of first dose/randomization
- •7. Major surgery within 30 days of first dose/randomization or planning to have surgery (except for minor surgical procedures) during the study
- •8. Received any investigational drug/agent within 30 days or 5 half-lives (whichever is longer) of first dose/randomization
- •9. Received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant
- •10. Has clinically significant residual toxicities associated with prior autologous bone marrow or peripheral blood stem cell transplant
- •11. Administered platelet transfusion or neutrophil growth factor within 2 weeks prior to the collection of screening hematology laboratory sample
- •12. Transplanted solid organ with the exception of a corneal transplant (= 3 months prior to first dose/randomization)
- •13. Received any mAb within 60 days of first dose/randomization
- •14. Serious concurrent illness (medical or psychiatric), uncontrolled infection, or any uncontrolled medical condition (eg, uncontrolled diabetes), including the presence of laboratory abnormalities, that places the subject at unacceptable risk by participating in the study or confounds the ability to interpret data from the study
- •15. Myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class II or higher heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic, clinically significant conduction system abnormalities, baseline QTc interval >450 milliseconds, history of hypokalemia, or any cardiac condition that is = Grade 3
- •16. Prior or concomitant malignancy (other than multiple myeloma) except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer for which the subject has been disease-free for = 3 years
- •17. Any other concomitant disease-related treatment such as, immunotherapy, biotherapy, radiotherapy, chemotherapy, investigative therapy, or immunosuppressive therapy/corticoid steroids (other than study specific treatments)
- •18. Vaccinated with live or attenuated vaccines within 4 weeks of the first administration of CNTO 328/placebo
- •19. Known to be seropositive for HIV, or active hepatitis A, B or C infection
- •20. Pregnant or lactating women
- •21. Known allergies or clinically significant reactions to murine, chimeric or human proteins
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