PHASE II STUDY OF CETUXIMAB FOR THE TREATMENT OF REFRACTORY OR RELAPSED MULTIPLE MYELOMA EMMA-1 (ERBITUX FOR MULTIPLE MYELOMA) - EMMA-1
- Conditions
- Relapsed or refractory multiple myeloma
- Registration Number
- EUCTR2005-005612-24-DE
- Lead Sponsor
- niversity of Cologne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
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
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
Bilirubin > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess activity of Cetuximab in patients with refractory/relapsed multiple myeloma;Secondary Objective: Safety profile of Cetuximab +/- Dexamethasone<br>Freedom from treatment failure<br>Progression-free survival<br>Overall survival<br>Pharmacogenomic evaluation of response to treatment;Primary end point(s): Overall response rate (complete response + partial response + minimal response)
- Secondary Outcome Measures
Name Time Method