EMMA-1 (Erbitux for Multiple Myeloma)

Prof. Dr. Andreas Engert

Status and phase

Terminated

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: Cetuximab +/- Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT00368121

EMMA-1

Details and patient eligibility

About

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

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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