Relapsed or refractory multiple myeloma
Conditions
Sponsors
University of Cologne
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
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, psychatric illness Insufficient bone marrow reserve (Leucocytes 3.0 mg/dl A FEV1 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess activity of Cetuximab in patients with refractory/relapsed multiple myeloma;Secondary Objective: Safety profile of Cetuximab +/- Dexamethasone Freedom from treatment failure Progression-free survival Overall survival Pharmacogenomic evaluation of response to treatment;Primary end point(s): Overall response rate (complete response + partial response + minimal response) | — |
Countries
Germany
Outcome results
None listed