EMMA-1 (Erbitux for Multiple Myeloma) (EMMA-1)
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Cetuximab
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- University of Cologne, Department I of Internal Medicine
- Universtiy Hospital of Muenster, Internal Medicine A
- University of Würzburg
Arms of the Study
Arm 1
Experimental
Cetuximab + Dexamethasone