EUCTR2005-005612-24-DE
Active, not recruiting
Phase 1
PHASE II STUDY OF CETUXIMAB FOR THE TREATMENT OF REFRACTORY OR RELAPSED MULTIPLE MYELOMA EMMA-1 (ERBITUX FOR MULTIPLE MYELOMA) - EMMA-1
niversity of Cologne0 sites0 target enrollmentApril 24, 2006
ConditionsRelapsed or refractory multiple myeloma
DrugsErbitux
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Relapsed or refractory multiple myeloma
- Sponsor
- niversity of Cologne
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
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 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
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 \< 1500/µl; Thromocytes \< 50000/µl)
- •Creatinine\-Clearance \< 30 ml/min or serum creatinine \> 3\.0 mg/dl
- •A FEV1 \< 50% of the reference value
Outcomes
Primary Outcomes
Not specified
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