A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma

Study Overview
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Brief Summary
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To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma

Official Title
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A Multicenter, Randomized, Parallel-group , Double Blind, Placebo-controlled Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: A (Thalidomide + Dexamethasone)
* Drug: B (Placebo + Dexamethasone)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active Multiple Myeloma Stage II or III Durie Salmon Measurable levels of myeloma paraprotein in serum (≥1.0g/dL) or urine (≥ 0.2g excreted in a 24-hour collection sample) Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 Women of child bearing potential must agree to abstain for heterosexual intercourse or use 2 methods of contraception, one effective (for example hormonal or tubal ligation) and one barrier (for example latex condom, diaphragm) Males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity Exclusion Criteria: Pregnant or lactating females Peripheral neuropathy ≥ to grade 2 of the NCI CTC. Prior history of malignancy unless subject has been free of disease for ≥ 3 years Lab abnormality: Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L) Lab abnormality: Platelet count <50,000/mm^3 (50.0 x 10^9/L) Lab abnormality: Serum creatinine >3.0 mg/dL (265 µmol/L) Lab abnormality: Serum glutamic oxaloacetic transaminase (SGOT) /Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine transaminase (ALT) >3.0 x upper limit of normal (ULN) Lab abnormality: Serum total bilirubin > 2.0 mg/dL (34 µmol/L)

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A (Thalidomide & Dexamethasone)<br>Thalidomide 50mg/day + Dexamethasone 40mg | Drug: A (Thalidomide + Dexamethasone)<br>* Thalidomide 50mg/day + Dexamethasone 40mg<br>* Other names: Thalidomide;|
| Placebo Comparator: B (Dexamethasone and placebo)<br>Dexamethasone and placebo | Drug: B (Placebo + Dexamethasone)<br>* Placebo + Dexamethasone 40mg<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to tumor progression (TTP) | Time to tumor progression (TTP) | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who survived | Number of patients who survived | Up to 3 years | 
| Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone) | Time to first symptomatic skeletal-related event (SRE)(clinical need for radiation therapy or surgery to bone) | Up to 3 years | 
| Myeloma response rate | Myeloma response determination criteria developed by Bladé et al 1998 | Up to 3 years | 
| Number of participants with adverse events | Number of participants with adverse events | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Newly Diagnosed Multiple Myeloma, Multiple Myeloma