Phase II Study of Cetuximab for the Refractory or Relapsed Multiple Myeloma EMMA-1(Erbitux for Multiple Myeloma)
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