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Sponsors and Collaborators: |
University of Cologne Clinical Trials Center Cologne |
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Information provided by: | University of Cologne |
ClinicalTrials.gov Identifier: | NCT00368121 |
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 |
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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) |
Estimated Enrollment: | 33 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Cetuximab dosing schedule:
Dexamethasone dosing schedule:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
University of Cologne, Department I of Internal Medicine | |
Cologne, Germany, 50931 | |
University of Würzburg | |
Würzburg, Germany |
Principal Investigator: | Andreas Engert, Prof. MD | University of Cologne |
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: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00368121 History of Changes |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Multiple Myeloma Cetuximab |
Anti-Inflammatory Agents Dexamethasone Immunoproliferative Disorders Antineoplastic Agents, Hormonal Blood Protein Disorders Hematologic Diseases Hormone Antagonists Blood Coagulation Disorders Cetuximab Hormones, Hormone Substitutes, and Hormone Antagonists Vascular Diseases |
Antiemetics Paraproteinemias Hemostatic Disorders Hormones Glucocorticoids Multiple Myeloma Hemorrhagic Disorders Peripheral Nervous System Agents Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
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 |