Status:
TERMINATED
EMMA-1 (Erbitux for Multiple Myeloma)
Lead Sponsor:
Prof. Dr. Andreas Engert
Collaborating Sponsors:
The Clinical Trials Centre Cologne
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
EMMA-1 is an open-label, non-randomized, two-stage phase II study. Patients with refractory multiple myeloma stage II or III or relapsed disease after at least one line of treatment will receive Cetux...
Eligibility Criteria
Inclusion
- 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 performances 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 30 days of study entry
- Signed written informed consent
Exclusion
- 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, psychiatric illness
- Insufficient bone marrow reserve (Leucocytes \< 1500/µl; Thrombocytes \< 50000/µl)
- Creatinine-Clearance \< 30 ml/min or Crea \> 3.0 mg/dl
- Bilirubin \> 2 mg/dl; ASAT, ALAT \> 100 U/l
- Pregnancy (absence confirmed by serum/urine beta-HCG) or breast-feeding
- FEV1 \< 50% of the reference value
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00368121
Start Date
August 1 2006
End Date
June 1 2012
Last Update
July 13 2012
Active Locations (3)
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1
University of Cologne, Department I of Internal Medicine
Cologne, Germany, 50931
2
Universtiy Hospital of Muenster, Internal Medicine A
Münster, Germany, 48129
3
University of Würzburg
Würzburg, Germany