EMMA-1 (Erbitux for Multiple Myeloma) | NCT00368121

Studies
EMMA-1 (Erbitux for Multiple Myeloma)

NCT00368121

Sponsor

Prof. Dr. Andreas Engert

Status

Terminated

Last Update Posted

Jul 13, 2012Estimated

Enrollment

13Actual

Phase

Phase 2

Conditions

Multiple Myeloma

Interventions

Cetuximab +/- Dexamethasone

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of recruitable patients

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Aug 23, 2006

First Submission Date that Met QC Criteria

Aug 23, 2006

First Posted Date

Aug 24, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2012

Last Update Posted Date

Jul 13, 2012Estimated

Name	Class
The Clinical Trials Centre Cologne	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cetuximab + Dexamethasone	Experimental		Drug: Cetuximab +/- Dexamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cetuximab +/- Dexamethasone	Drug	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Safety profile of Cetuximab +/- Dexamethasone		During 16 weeks of intervention and 8 weeks after
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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University of Cologne, Department I of Internal Medicine		Cologne		50931	Germany
Universtiy Hospital of Muenster, Internal Medicine A

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins