EMMA-1 (Erbitux for Multiple Myeloma)

NCT00368121 | Terminated Phase 2

• 1 other identifier: EMMA-1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

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

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Cetuximab

Outcome Measures

Primary Outcomes (1)

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

  After 16 weeks

Secondary Outcomes (5)

• 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.

• Progression-free survival

  from the date of registration until first documentation of progression/relapse of disease or death related to MM

• Overall survival

  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

  After 16 weeks of intervention

Study Arms (1)

Cetuximab + Dexamethasone

EXPERIMENTAL

Drug: Cetuximab +/- Dexamethasone

Interventions

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

Also known as: Erbitux

Cetuximab + Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. Andreas Engert: lead
• The Clinical Trials Centre Cologne: collaborator

Study Sites (3)

University of Cologne, Department I of Internal Medicine

Cologne, 50931, Germany

Location

Universtiy Hospital of Muenster, Internal Medicine A

Münster, 48129, Germany

Location

University of Würzburg

Würzburg, Germany

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Andreas Engert, Prof. MD

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: August 23, 2006
• First Posted: August 24, 2006
• Study Start: August 1, 2006
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 13, 2012

Record last verified: 2012-07

Locations

DE (3)