Clinical trial NCT00368121: EMMA-1 (Erbitux for Multiple Myeloma)
Official title: Phase II Study of Cetuximab for the Refractory or Relapsed Multiple Myeloma EMMA-1(Erbitux for Multiple Myeloma)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Cetuximab
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: The Clinical Trials Centre Cologne
First posted: 2006-08-24
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Overall response rate (CR+PR+MR)at 16 weeks and during follow-up (every 3 months)
timeFrame: After 16 weeks
Secondary outcomes:
measure: Safety profile of Cetuximab +/- Dexamethasone
timeFrame: During 16 weeks of intervention and 8 weeks after
measure: Freedom from treatment failure
timeFrame: 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.
measure: Progression-free survival
timeFrame: from the date of registration until first documentation of progression/relapse of disease or death related to MM
measure: Overall survival
timeFrame: 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.
measure: Pharmacogenomic evaluation of response to treatment
timeFrame: After 16 weeks of intervention
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne, Department I of Internal Medicine
city: Muenster
country: Germany
facility: Universtiy Hospital of Muenster, Internal Medicine A
city: Würzburg
country: Germany
facility: University of Würzburg
Study officials:
affiliation: University of Cologne
name: Andreas Engert, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: