EMMA-1 (Erbitux for Multiple Myeloma) - Full Text View

Sponsor:	University of Cologne
Collaborator:	Clinical Trials Center Cologne
Information provided by:	University of Cologne
ClinicalTrials.gov Identifier:	NCT00368121

Purpose

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

Condition	Intervention	Phase
Multiple Myeloma	Drug: Cetuximab +/- Dexamethasone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Cetuximab for the Refractory or Relapsed Multiple Myeloma EMMA-1(Erbitux for Multiple Myeloma)

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Cetuximab Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by University of Cologne:

Primary Outcome Measures:

Overall response rate (CR+PR+MR)at 16 weeks and during follow-up (every 3 months) [ Time Frame: After 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety profile of Cetuximab +/- Dexamethasone [ Time Frame: During 16 weeks of intervention and 8 weeks after ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: No ]
Progression-free survival [ Time Frame: from the date of registration until first documentation of progression/relapse of disease or death related to MM ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
Pharmacogenomic evaluation of response to treatment [ Time Frame: After 16 weeks of intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	33
Study Start Date:	August 2006
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cetuximab + Dexamethasone: Experimental	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

Arms

Assigned Interventions

Cetuximab + Dexamethasone: Experimental

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368121

Locations

Germany
University of Cologne, Department I of Internal Medicine	Recruiting
Cologne, Germany, 50931
Contact: Andreas Engert, MD 0049221478 ext 5966 andreas.engert@uk-koeln.de
Contact: Kai Huebel, MD 0049221478 ext 3583 kai.huebel@uk-koeln.de
Principal Investigator: Andreas Engert, Prof. MD
Sub-Investigator: Bastian von Tresckow, MD
Sub-Investigator: Kai Huebel, PD MD
Sub-Investigator: Dennis Eichenauer, MD
Sub-Investigator: Boris Böll, MD
Sub-Investigator: Christof Scheid, MD
Sub-Investigator: Udo Holtick, MD
University of Würzburg	Recruiting
Würzburg, Germany
Contact: H Einsele, MD 0049 93120170840 Einsele_H@medizin.uni-wuerzburg.de
Contact: M Goebeler, MD 0049 931 201 70840 goebeler_m@klinik.uni-wuerzburg.de
Principal Investigator: H Einsele, MD
Universtiy Hospital of Muenster, Internal Medicine A	Not yet recruiting
Muenster, Germany, 48129
Contact: Martin Kropff, MD +49(0) 251-834 ext 6012 Martin.Kropff@ukmuenster.de
Sub-Investigator: Guido Bisping, MD
Sub-Investigator: Derya Önaldi-Mohr, MD

Sponsors and Collaborators

University of Cologne

Clinical Trials Center Cologne

Investigators

Principal Investigator:

Andreas Engert, Prof. MD

University of Cologne

More Information

No publications provided

Responsible Party:	Department I of Internal Medicine; University Hospital of Cologne ( Prof. Dr. Engert )
Study ID Numbers:	EMMA-1
Study First Received:	August 23, 2006
Last Updated:	October 22, 2009
ClinicalTrials.gov Identifier:	NCT00368121 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by University of Cologne:

Multiple Myeloma
Cetuximab

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Dexamethasone acetate
Immunoproliferative Disorders

Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Cetuximab
Vascular Diseases
Gastrointestinal Agents
Glucocorticoids
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Autonomic Agents
Peripheral Nervous System Agents
Lymphoproliferative Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010