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

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ClinicalTrials.gov Identifier: NCT00368121
Recruitment Status : Terminated (Lack of recruitable patients)
First Posted : August 24, 2006
Last Update Posted : July 13, 2012
Sponsor:
Collaborator:
The Clinical Trials Centre Cologne
Information provided by (Responsible Party):
Prof. Dr. Andreas Engert, University of Cologne

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


Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Cetuximab +/- Dexamethasone Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : August 2006
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012


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 Name: Erbitux



Primary Outcome Measures :
  1. Overall response rate (CR+PR+MR)at 16 weeks and during follow-up (every 3 months) [ Time Frame: After 16 weeks ]

Secondary Outcome Measures :
  1. Safety profile of Cetuximab +/- Dexamethasone [ Time Frame: During 16 weeks of intervention and 8 weeks after ]
  2. 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. ]
  3. Progression-free survival [ Time Frame: from the date of registration until first documentation of progression/relapse of disease or death related to MM ]
  4. 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. ]
  5. Pharmacogenomic evaluation of response to treatment [ Time Frame: After 16 weeks of intervention ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00368121


Locations
Germany
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
Investigators
Principal Investigator: Andreas Engert, Prof. MD University of Cologne

Responsible Party: Prof. Dr. Andreas Engert, Prof. Dr., University of Cologne
ClinicalTrials.gov Identifier: NCT00368121     History of Changes
Other Study ID Numbers: EMMA-1
First Posted: August 24, 2006    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012

Keywords provided by Prof. Dr. Andreas Engert, University of Cologne:
Multiple Myeloma
Cetuximab

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Cetuximab
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors