Phase II study of cetuximab for the treatment of refractory or relapsed multiple myeloma: Erbitux for Multiple MyelomA (EMMA)
| ISRCTN | ISRCTN81968533 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81968533 |
| ClinicalTrials.gov number | NCT00368121 |
| Secondary identifying numbers | EMMA-1 |
- Submission date
- 30/11/2005
- Registration date
- 22/09/2006
- Last edited
- 07/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Andreas Engert
Scientific
Scientific
University Hospital of Cologne
Department I of Internal Medicine
Kerpener Str. 62
Cologne
50937
Germany
Study information
| Study design | Open-label, non-randomised phase II study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Phase II study of cetuximab for the treatment of refractory or relapsed multiple myeloma: Erbitux for Multiple MyelomA (EMMA) |
| Study acronym | EMMA-1 |
| Study objectives | Efficacy of Erbitux in relapsed or refractory multiple myeloma. |
| Ethics approval(s) | Ethics commission of the Medical Faculty of the University Hospital of Cologne, approval received on 03/08/2006 (reference number: 06-062). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Cetuximab (Erbitux) |
| Primary outcome measure | 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 study start date | 01/03/2006 |
| Completion date | 30/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 33 |
| Total final enrolment | 15 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2006 |
| Date of final enrolment | 30/11/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
University Hospital of Cologne
Cologne
50937
Germany
50937
Germany
Sponsor information
University of Cologne (Germany)
University/education
University/education
Kerpener Str. 62
Cologne
50937
Germany
"ROR" |
https://ror.org/00rcxh774 |
|---|
Funders
Funder type
Industry
Merck Pharma GmbH (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2014 | 07/01/2021 | Yes | No |
Editorial Notes
07/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NCT number has been added.
