EMMA-1 (Erbitux for Multiple Myeloma)

Multiple Myeloma Clinical Trial

— EMMA-1  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00368121
• Other study ID #: EMMA-1
• Status: Terminated
• Phase: Phase 2
• First received: August 23, 2006
• Last updated: July 12, 2012
• Start date: August 2006
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
Germany	University of Cologne, Department I of Internal Medicine	Cologne
Germany	Universtiy Hospital of Muenster, Internal Medicine A	Muenster
Germany	University of Würzburg	Würzburg

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Dr. Andreas Engert	The Clinical Trials Centre Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (CR+PR+MR)at 16 weeks and during follow-up (every 3 months)		After 16 weeks	No
Secondary	Safety profile of Cetuximab +/- Dexamethasone		During 16 weeks of intervention and 8 weeks after	Yes
Secondary	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.	No
Secondary	Progression-free survival		from the date of registration until first documentation of progression/relapse of disease or death related to MM	No
Secondary	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.	No
Secondary	Pharmacogenomic evaluation of response to treatment		After 16 weeks of intervention	No