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

Primary Purpose

Multiple Myeloma

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Cetuximab +/- Dexamethasone
Sponsored by
Prof. Dr. Andreas Engert
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Cetuximab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cetuximab + Dexamethasone

Arm Description

Outcomes

Primary Outcome Measures

Overall response rate (CR+PR+MR)at 16 weeks and during follow-up (every 3 months)

Secondary Outcome Measures

Safety profile of Cetuximab +/- Dexamethasone
Freedom from treatment failure
Progression-free survival
Overall survival
Pharmacogenomic evaluation of response to treatment

Full Information

First Posted
August 23, 2006
Last Updated
July 12, 2012
Sponsor
Prof. Dr. Andreas Engert
Collaborators
The Clinical Trials Centre Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT00368121
Brief Title
EMMA-1 (Erbitux for Multiple Myeloma)
Acronym
EMMA-1
Official Title
Phase II Study of Cetuximab for the Refractory or Relapsed Multiple Myeloma EMMA-1(Erbitux for Multiple Myeloma)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitable patients
Study Start Date
August 2006 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. Andreas Engert
Collaborators
The Clinical Trials Centre Cologne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Cetuximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cetuximab + Dexamethasone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cetuximab +/- Dexamethasone
Other Intervention Name(s)
Erbitux
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall response rate (CR+PR+MR)at 16 weeks and during follow-up (every 3 months)
Time Frame
After 16 weeks
Secondary Outcome Measure Information:
Title
Safety profile of Cetuximab +/- Dexamethasone
Time Frame
During 16 weeks of intervention and 8 weeks after
Title
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.
Title
Progression-free survival
Time Frame
from the date of registration until first documentation of progression/relapse of disease or death related to MM
Title
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.
Title
Pharmacogenomic evaluation of response to treatment
Time Frame
After 16 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Engert, Prof. MD
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cologne, Department I of Internal Medicine
City
Cologne
ZIP/Postal Code
50931
Country
Germany
Facility Name
Universtiy Hospital of Muenster, Internal Medicine A
City
Muenster
ZIP/Postal Code
48129
Country
Germany
Facility Name
University of Würzburg
City
Würzburg
Country
Germany

12. IPD Sharing Statement

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EMMA-1 (Erbitux for Multiple Myeloma)

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