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

This study has been terminated.
(Lack of recruitable patients)
The Clinical Trials Centre Cologne
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, University of Cologne Identifier:
First received: August 23, 2006
Last updated: July 12, 2012
Last verified: July 2012

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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

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 ]

Secondary Outcome Measures:
  • Safety profile of Cetuximab +/- Dexamethasone [ Time Frame: 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. ]
  • Progression-free survival [ Time Frame: 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. ]
  • Pharmacogenomic evaluation of response to treatment [ Time Frame: After 16 weeks of intervention ]

Enrollment: 13
Study Start Date: August 2006
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Erbitux


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00368121

University of Cologne, Department I of Internal Medicine
Cologne, Germany, 50931
Universtiy Hospital of Muenster, Internal Medicine A
Muenster, Germany, 48129
University of Würzburg
Würzburg, Germany
Sponsors and Collaborators
Prof. Dr. Andreas Engert
The Clinical Trials Centre Cologne
Principal Investigator: Andreas Engert, Prof. MD University of Cologne
  More Information

Responsible Party: Prof. Dr. Andreas Engert, Prof. Dr., University of Cologne Identifier: NCT00368121     History of Changes
Other Study ID Numbers: EMMA-1
Study First Received: August 23, 2006
Last Updated: July 12, 2012

Keywords provided by University of Cologne:
Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on April 27, 2017