Thalidomide/Dexamethasone vs MP for Induction Therapy and Thalidomide/Intron A vs Intron A for Maintenance Therapy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Thalidomide/Dexamethasone vs Melphalan/Prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thalidomide/Dexamethasone vs Melphalan/Prednisone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 
| Response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  |  | 
| Time to response |  |  | 
| Toxicity |  |  | 
| Quality of life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, first line treatment, thalidomide, melphalan