EMMA-1 (Erbitux for Multiple Myeloma)

Sponsor

Prof. Dr. Andreas Engert (Other)

Overall Status

Terminated

CT.gov ID

NCT00368121

Collaborator

The Clinical Trials Centre Cologne (Other)

Enrollment

Locations

Arm

Duration (Months)

4.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Cetuximab +/- Dexamethasone	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study of Cetuximab for the Refractory or Relapsed Multiple Myeloma EMMA-1(Erbitux for Multiple Myeloma)

Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cetuximab + Dexamethasone	Drug: Cetuximab +/- 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 Other Names: Erbitux

Arm

Intervention/Treatment

Experimental: Cetuximab + Dexamethasone

Drug: Cetuximab +/- 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

Other Names:

Erbitux

Outcome Measures

Primary Outcome Measures

Overall response rate (CR+PR+MR)at 16 weeks and during follow-up (every 3 months) [After 16 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University of Cologne, Department I of Internal Medicine	Cologne	Germany	50931
2	Universtiy Hospital of Muenster, Internal Medicine A	Muenster	Germany	48129
3	University of Würzburg	Würzburg	Germany