Condition category
Cancer
Date applied
30/11/2005
Date assigned
22/09/2006
Last edited
22/09/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andreas Engert

ORCID ID

Contact details

University Hospital of Cologne
Department I of Internal Medicine
Kerpener Str. 62
Cologne
50937
Germany

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

Sponsor information

Organisation

University of Cologne (Germany)

Sponsor details

Kerpener Str. 62
Cologne
50937
Germany

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes