Thalidomide/Dexamethasone vs MP for Induction Therapy and Thalidomide/Intron A vs Intron A for Maintenance Therapy
This study has been completed.
Sponsor:
Austrian Forum Against Cancer
Information provided by:
Austrian Forum Against Cancer
ClinicalTrials.gov Identifier:
NCT00205751
First received: September 12, 2005
Last updated: July 22, 2010
Last verified: July 2010
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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 2 Phase 3 |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Thalidomide
Prednisone
Melphalan
Dexamethasone acetate
Dexamethasone sodium phosphate
Melphalan hydrochloride
Interferon
Interferon Alfa-2a
U.S. FDA Resources
Further study details as provided by Austrian Forum Against Cancer:
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with Multiple Myeloma of IgG, IgA, IgD, IgE, IgM lambda or kappa light chain, low secretory or non-secretory disease
- WHO performance status 0,1,2,or 3
- No prior treatment of multiple myeloma
- Clear requirement of treatment (usually Durie/Salmon stage II or III)
- Anticipated life expectancy of at least 3 months
- Adequate organ function
- Minimum recovery period of 2 weeks following any major surgical procedure before entry into this study
- Women, who are sterilized via hysterectomy or bilateral tubal ligation or at least one year post-menopausal
- Age of at least 19 years, there is no upper age limit patients must have been informed and must have signed an informed consent
Exclusion Criteria:
- Extramedullary plasmocytoma or solitary plasmocytoma without evidence of dissemination of disease
- Benign monoclonal gammopathy
- Multiple myeloma of IgM without osteolytic bone lesions
- Smouldering myeloma
- More than 3 irradiation fields
- Irreversible performance status of WHO4
- Prior treatment of myeloma with any of the following: chemotherapeutic or immunomodulatory agents, corticosteroids, antiangiogenic agents or other investigational drugs
- Women of childbearing potential
- Preexisting peripheral polyneuropathy
- Congestive heart failure NYHA III, IV
- Acute infection requiring systemic antibiotics at study entry until resolved
- Any uncontrolled underlying medical condition (eg diabetes, glaucoma)
- Second primary malignancy (with the exception of cervical carcinoma in situ and non-myeloma skin malignancies) unless patient has been disease-free for at least three years
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205751
Locations
| Austria | |
| Wilhelminenspital, 1st Medical Department-center for oncology and hematology | |
| Vienna, Austria, 1190 | |
Sponsors and Collaborators
Austrian Forum Against Cancer
Investigators
| Principal Investigator: | Heinz Ludwig, MD,Univ.Prof | Wilhelminenspital 1st medical dep.-center for oncology and hematology |
More Information
No publications provided by Austrian Forum Against Cancer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Keywords provided by Austrian Forum Against Cancer:
|
Multiple Myeloma first line treatment thalidomide melphalan |
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 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 |
ClinicalTrials.gov processed this record on May 19, 2013