NCT00368121终止2 期
Phase II Study of Cetuximab for the Refractory or Relapsed Multiple Myeloma EMMA-1(Erbitux for Multiple Myeloma)
Prof. Dr. Andreas Engert3 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2006年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 3
- 主要终点
- Overall response rate (CR+PR+MR)at 16 weeks and during follow-up (every 3 months)
研究概览
简要总结
EMMA-1 is an open-label, non-randomized, two-stage phase II study. Patients with refractory multiple myeloma stage II or III or relapsed disease after at least one line of treatment will receive Cetuximab+/-Dexamethasone.
The planed treatment duration per patient is 16 weeks. Patients achieving a response or stable disease after 16 weeks of treatment may continue study medication for 6 more months (patients receiving Cetuximab alone) or for 3 more months (patients receiving Cetuximab plus Dexamethasone). Responding patients who relapse during follow-up period of two years may receive a second treatment with Cetuximab following initial study guidelines
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple myeloma diagnosed according to the Durie-criteria in stage II or III (Salmon and Durie)
- •Measurable disease
- •Refractory or relapsed disease after at least one line of treatment
- •Male or female >= 18 years of age
- •Life expectancy > 12 weeks
- •ECOG performances status 0-2
- •If of childbearing potential, willingness to use effective contraceptive method for the study duration and 6 months post-dosing.
- •No surgery, radiotherapy or chemotherapy or any investigational agent within 30 days of study entry
- •Signed written informed consent
排除标准
- •Asecretory multiple myeloma
- •Patients eligible and willing to undergo high dose chemotherapy followed by autologous stem cell transplantation
- •Prior allogeneic transplantation
- •Prior antibody or EGFR-pathway targeting therapy
- •Severe cardiovascular disease like functionally restricting heart rhythm disturbance or heart malformation or severe hypertension, or cardiac insufficiency > NYHA-II
- •HIV Infection, Hepatitis B or C
- •Brain disorders, psychiatric illness
- •Insufficient bone marrow reserve (Leucocytes < 1500/µl; Thrombocytes < 50000/µl)
- •Creatinine-Clearance < 30 ml/min or Crea > 3.0 mg/dl
- •Bilirubin > 2 mg/dl; ASAT, ALAT > 100 U/l
- •Pregnancy (absence confirmed by serum/urine beta-HCG) or breast-feeding
- •FEV1 < 50% of the reference value
- •Active secondary malignancy
- •Legal incapacity or limited legal capacity
- •Having participated in another clinical trial or any investigational agent in the preceding 30 days
- •Known allergic/hypersensitivity reaction to any compounds of the treatment
- •Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
- •Known drug abuse/alcohol abuse
研究组 & 干预措施
Cetuximab + Dexamethasone
Experimental
干预措施: Cetuximab +/- Dexamethasone (Drug)
结局指标
主要结局
Overall response rate (CR+PR+MR)at 16 weeks and during follow-up (every 3 months)
时间窗: After 16 weeks
次要结局
- Safety profile of Cetuximab +/- Dexamethasone(During 16 weeks of intervention and 8 weeks after)
- Freedom from treatment failure(From the date of registration until the first event or (if none occurs) until the date of the last determination of continuing complete/partial remission.)
- Progression-free survival(from the date of registration until first documentation of progression/relapse of disease or death related to MM)
- Overall survival(From the date of registration until the date of death from any cause or (if the patients is alive) until the date of last information.)
- Pharmacogenomic evaluation of response to treatment(After 16 weeks of intervention)
研究者
Prof. Dr. Andreas Engert
Prof. Dr.
University of Cologne
研究点 (3)
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