EMMA-1 (Erbitux for Multiple Myeloma)
Information source: University of Cologne
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Cetuximab +/- Dexamethasone (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Prof. Dr. Andreas Engert Official(s) and/or principal investigator(s): Andreas Engert, Prof. MD, Principal Investigator, Affiliation: University of Cologne
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
Clinical Details
Official title: Phase II Study of Cetuximab for the Refractory or Relapsed Multiple Myeloma EMMA-1(Erbitux for Multiple Myeloma)
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Overall response rate (CR+PR+MR)at 16 weeks and during follow-up (every 3 months)
Secondary outcome: Safety profile of Cetuximab +/- DexamethasoneFreedom from treatment failure Progression-free survival Overall survival Pharmacogenomic evaluation of response to treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University of Cologne, Department I of Internal Medicine, Cologne 50931, Germany
Universtiy Hospital of Muenster, Internal Medicine A, Muenster 48129, Germany
University of Würzburg, Würzburg, Germany
Additional Information
Starting date: August 2006
Last updated: July 12, 2012
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