ISRCTN81968533CompletedNot Applicable
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 enrollmentStarted: September 22, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 33
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •11. Pregnancy (absence confirmed by serum/urine Beta-Human Chorionic Gonadotropin [Beta-HCG]) or breast-feeding
- •12. Pulmonary dysfunction
- •13. Active secondary malignancy
- •14. Legal incapacity or limited legal capacity
- •15. Having participated in another clinical trial or any investigational agent in the preceding 30 days
- •16. Known allergic/hypersensitivity reaction to any compounds of the treatment
- •17. Other previous malignancy within five years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- •18. 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
- •19. Known drug abuse/alcohol abuse
Investigators
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