EMMA-1 (Erbitux for Multiple Myeloma)

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

Timeline

Start

2006-08

Primary completion

2012-06

Completion

2012-06

Outcome

Outcome not reported

Stopped (Enrollment): “Lack of recruitable patients”

Drugs

Indications