Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EMMA-1
Study information
Scientific title
Acronym
EMMA-1
Study hypothesis
Efficacy of Erbitux in relapsed or refractory multiple myeloma.
Ethics approval
Ethics commission of the Medical Faculty of the University Hospital of Cologne, approval received on 03/08/2006 (reference number: 06-062).
Study design
Open-label, non-randomised phase II study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Relapsed or refractory multiple myeloma
Intervention
Cetuximab (Erbitux) loading dose of 400 mg/m2, followed by weekly doses of 250 mg/m2. Cetuximab will be administered once weekly by intravenous infusion.
Intervention type
Drug
Phase
Phase II
Drug names
Cetuximab (Erbitux)
Primary outcome measures
To assess efficacy of Cetuximab in patients with refractory/relapsed multiple myeloma.
Secondary outcome measures
1. Safety profile of Cetuximab with/without Dexamethasone
2. Freedom from treatment failure
3. Progression-free survival
4. Overall survival
5. Pharmacogenomic evaluation of response to treatment
Overall trial start date
01/03/2006
Overall trial end date
30/11/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
33
Participant 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
Recruitment start date
01/03/2006
Recruitment end date
30/11/2009
Locations
Countries of recruitment
Germany
Trial participating centre
University Hospital of Cologne
Cologne
50937
Germany
Funders
Funder type
Industry
Funder name
Merck Pharma GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary