Overview

EMMA-1 (Erbitux for Multiple Myeloma)

Status:
Terminated
Trial end date:
2012-06-01
Target enrollment:
0
Participant gender:
All
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 Cetuximab+/-Dexamethasone. The planed treatment duration per patient is 16 weeks. Patients achieving a response or stable disease after 16 weeks of treatment may continue study medication for 6 more months (patients receiving Cetuximab alone) or for 3 more months (patients receiving Cetuximab plus Dexamethasone). Responding patients who relapse during follow-up period of two years may receive a second treatment with Cetuximab following initial study guidelines
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Prof. Dr. Andreas Engert
Collaborator:
The Clinical Trials Centre Cologne
Treatments:
BB 1101
Cetuximab
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Criteria
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