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| Sponsor: | Austrian Forum Against Cancer |
|---|---|
| Information provided by: | Austrian Forum Against Cancer |
| ClinicalTrials.gov Identifier: | NCT00205751 |
Purpose
This is an international multi-center prospective, double randomized, open, controlled phase III study with a phase II entrance phase to compare the therapeutic efficacy of thalidomide plus dexamethasone to conventional melphalan plus prednisone in newly diagnosed myeloma patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Thalidomide/Dexamethasone vs Melphalan/Prednisone |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | International, Multi-center, Prospective, Double Randomized, Open Phase III Study Evaluating Thalidomide/Dexamethasone Versus Melphalan/Prednisone as Induction Therapy and Thalidomide/Interferon-alpha Versus Interferon-alpha as Maintenance Therapy in Newly Diagnosed Patients With Multiple Myeloma |
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Austria | |
| Wilhelminenspital, 1st Medical Department-center for oncology and hematology | |
| Vienna, Austria, 1190 | |
| Principal Investigator: | Heinz Ludwig, MD,Univ.Prof | Wilhelminenspital 1st medical dep.-center for oncology and hematology |
More Information
| ClinicalTrials.gov Identifier: | NCT00205751 History of Changes |
| Other Study ID Numbers: | 01-002-0601 |
| Study First Received: | September 12, 2005 |
| Last Updated: | July 22, 2010 |
| Health Authority: | Austria: Federal Ministry for Health and Women |
|
Multiple Myeloma first line treatment thalidomide melphalan |
|
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 Interferon-alpha |
Melphalan Thalidomide Dexamethasone acetate Dexamethasone Prednisone Dexamethasone 21-phosphate BB 1101 Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Anti-Inflammatory Agents Antiemetics |