EMMA-1 (Erbitux for Multiple Myeloma)

NCT ID: NCT00368121

Last Updated: 2012-07-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2012-06-30

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

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Cetuximab

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cetuximab + Dexamethasone

Group Type: EXPERIMENTAL

Cetuximab +/- Dexamethasone

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Erbitux

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Clinical Trials Centre Cologne

OTHER

Sponsor Role: collaborator

Prof. Dr. Andreas Engert

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Andreas Engert

Prof. Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andreas Engert, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

University of Cologne, Department I of Internal Medicine

Cologne, , Germany

Universtiy Hospital of Muenster, Internal Medicine A

Münster, , Germany

University of Würzburg

Würzburg, , Germany

Countries

Germany

Other Identifiers

EMMA-1

Identifier Type: -

Identifier Source: org_study_id