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