Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Cetuximab
Brief 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
Interventions
DRUGCetuximab +/- Dexamethasone
Cetuximab dosing schedule: • Loading dose of 400 mg/m2, followed by weekly doses of 250 mg/m2. Cetuximab will be administered once weekly over 16 weeks. Mode of administration: intravenous infusion Dexamethasone dosing schedule: • 20 mg administered on day 1-3, q1w, starting week 5 if evidence of tumor progression or week 9 if no PR or CR to Cetuximab alone. Mode of administration: orally
Sponsors
The Clinical Trials Centre Cologne
Prof. Dr. Andreas Engert
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (CR+PR+MR)at 16 weeks and during follow-up (every 3 months) | After 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety profile of Cetuximab +/- Dexamethasone | During 16 weeks of intervention and 8 weeks after |
| Freedom from treatment failure | From the date of registration until the first event or (if none occurs) until the date of the last determination of continuing complete/partial remission. |
| Progression-free survival | from the date of registration until first documentation of progression/relapse of disease or death related to MM |
| Overall survival | From the date of registration until the date of death from any cause or (if the patients is alive) until the date of last information. |
| Pharmacogenomic evaluation of response to treatment | After 16 weeks of intervention |
Countries
Germany
Outcome results
None listed