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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 +/- Dexamethasone

Freedom 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

Page last updated: August 20, 2015

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