PHASE II STUDY OF CETUXIMAB FOR THE TREATMENT OF REFRACTORY OR RELAPSED MULTIPLE MYELOMA EMMA-1 (ERBITUX FOR MULTIPLE MYELOMA) - EMMA-1

niversity of Cologne0 个研究点目标入组 0 人开始时间: 2006年4月24日最近更新: 2020年12月7日

适应症

试验速览

暂无简介。

•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 performance 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 4 weeks of study entry
•Signed written informed consent
•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

•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, psychatric illness
•Insufficient bone marrow reserve (Leucocytes < 1500/µl; Thromocytes < 50000/µl)
•Creatinine-Clearance < 30 ml/min or serum creatinine > 3.0 mg/dl
•A FEV1 < 50% of the reference value
•Bilirubin > 2 mg/dl; ASAT, ALAT > 100 U/l
•Pregnancy (absence confirmed by serum/urine b-HCG) or breast-feeding
•Pulmonary dysfunction
•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

发起方

niversity of Cologne