Phase II sudy of cetuximab for the treatment of refractory or relapsed multiple myeloma Erbitux for Multiple MyelomA

niversity of Cologne (Germany)0 sites33 target enrollmentSeptember 22, 2006

Overview

No summary available.

Registry

who.int

Start Date

September 22, 2006

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Cologne (Germany)

•1\. Multiple myeloma diagnosed according to the Durie\-criteria in stage II or III (Salmon and Durie)
•2\. Measurable disease
•3\. Refractory or relapsed disease after at least one line of treatment
•4\. Male or female 18 years of age or older
•5\. Life expectancy more than 12 weeks
•6\. Eastern Cooperative Oncology Group (ECOG) performances status zero to two
•7\. If of childbearing potential, willingness to use effective contraceptive method for the study duration and six months post\-dosing
•8\. No surgery, radiotherapy or chemotherapy or any investigational agent within four weeks of study entry
•9\. Signed written informed consent

•1\. Asecretory multiple myeloma
•2\. Patients eligible and willing to undergo high dose chemotherapy followed by autologous stem cell transplantation
•3\. Prior allogenic transplantation
•4\. Prior antibody or Epidermal Growth Factor Receptor (EGFR)\-pathway targeting therapy
•5\. Severe cardiovascular disease like functionally restricting heart rhythm disturbance or heart malformation or severe hypertension, or cardiac insufficiency more than the New York Heart Association\-II
•6\. Human Immunodeficiency Virus (HIV) infection, Hepatitis B or C
•7\. Brain disorders, psychatric illness
•8\. Insufficient bone marrow reserve (leucocytes less than 1500/µl, thrombocytes less than 50000/µl)
•9\. Creatinine\-clearance less than 50 ml/min or serum creatinine more than 1\.8 mg/dl
•10\. Bilirubin more than 2 mg/dl, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) more than 100 U/l