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Phase II Study of Cetuximab for the Refractory or Relapsed Multiple Myeloma EMMA-1(Erbitux for Multiple Myeloma)

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

Phase II Study of Cetuximab for the Refractory or Relapsed Multiple Myeloma EMMA-1(Erbitux for Multiple Myeloma)

Inclusion Criteria:

- 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 Criteria:

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (CR+PR+MR)at 16 weeks and during follow-up (every 3 months)

Outcome Time Frame:

After 16 weeks

Safety Issue:


Principal Investigator

Andreas Engert, Prof. MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cologne


Germany: Paul-Ehrlich-Institut

Study ID:




Start Date:

August 2006

Completion Date:

June 2012

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Cetuximab
  • Multiple Myeloma
  • Neoplasms, Plasma Cell