EMMA-1 (Erbitux for Multiple Myeloma) (EMMA-1)

July 12, 2012 updated by: Prof. Dr. Andreas Engert

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 50931
        • University of Cologne, Department I of Internal Medicine
      • Muenster, Germany, 48129
        • Universtiy Hospital of Muenster, Internal Medicine A
      • Würzburg, Germany
        • University of Würzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate (CR+PR+MR)at 16 weeks and during follow-up (every 3 months)
Time Frame: After 16 weeks
After 16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety profile of Cetuximab +/- Dexamethasone
Time Frame: During 16 weeks of intervention and 8 weeks after
During 16 weeks of intervention and 8 weeks after
Freedom from treatment failure
Time Frame: 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.
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
Time Frame: from the date of registration until first documentation of progression/relapse of disease or death related to MM
from the date of registration until first documentation of progression/relapse of disease or death related to MM
Overall survival
Time Frame: 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.
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
Time Frame: After 16 weeks of intervention
After 16 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Andreas Engert

Collaborators

The Clinical Trials Centre Cologne

Investigators

  • Principal Investigator: Andreas Engert, Prof. MD, University of Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 23, 2006

First Submitted That Met QC Criteria

August 23, 2006

First Posted (Estimate)

August 24, 2006

Study Record Updates

Last Update Posted (Estimate)

July 13, 2012

Last Update Submitted That Met QC Criteria

July 12, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMMA-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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