Thalidomide-Dexamethasone for Multiple Myeloma
Objective is to assess the activity of the combination of thalidomide and dexamethasone in patients with previously untreated multiple myeloma.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Thalidomide-Dexamethasone for Multiple Myeloma|
- Response Rate [ Time Frame: Baseline, with each course and monthly tests ] [ Designated as safety issue: No ]
|Study Start Date:||September 2001|
|Study Completion Date:||May 2005|
|Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
|Experimental: Thalidomide + Dexamethasone||
100 mg capsules by mouth daily each evening
Other Name: ThalomidDrug: Dexamethasone
20 mg/m^2 taken by mouth each morning on days 1-4, 9-12 and 17-20.
Other Name: Decadron
This study will examine the potential efficacy of thalidomide-dexamethasone in the treatment of patients with previously untreated multiple myeloma.
- Thalidomide is supplied as 50 mg capsules to be taken by mouth.
- Thalidomide 200 mg daily each evening at bedtime increasing by 100-200 mg increments (according to patient tolerability) every 4 weeks.
For elderly patients, or those with poor performance status or comorbid conditions which may affect tolerance of the thalidomide-dexamethasone combination, the initial dose may be reduced by 50-100 mg decrements and escalated weekly by 50-100 mg increments to tolerance. For patients who experience significant toxicity (> grade 2) or are otherwise unable to tolerate this drug combination, the dose will be reduced by 50-100 mg decrements. For some patients with > grade 2 toxicity, it may be necessary to hold the thalidomide dose until improvement of the side effect with subsequent resumption of the dose after dose reduction as outlined above.
Dexamethasone 20mg/m2 each morning after breakfast on days 1-4, 9-12, 17-20, with a repeat cycle after a 1-2 week rest period. In case of partial remission, maintenance treatment with thalidomide alone will be continued for as long as remission is sustained at a dose free of side effects.
For patients achieving CR, consolidation with thalidomide-dexamethasone for 4-6 months followed by follow-up without maintenance treatment. No maximum trial period is planned.
At relapse patients may be reinitiated on the original thalidomide-pulse dexamethasone program and responding patients may be maintained on thalidomide alone (CR) or daily thalidomide and dexamethasone (days 1-4) until relapse.
Patients who experience significant toxicity (grade 2 or more) at any time during therapy will receive a lower dose after treatment is interrupted.
In an attempt to avoid deep venous thrombosis, all patients for whom anticoagulation is not contraindicated will be offered therapeutic anticoagulation (INR 1.5-2.5) with coumadin or therapeutic doses of low molecular weight heparin.
Patients must be willing to return for evaluation every 4 weeks since thalidomide may only be prescribed for 28 day intervals.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038090
|United States, Texas|
|University of Texas M. D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Donna M Weber, M.D.||UT MD Anderson Cancer Center|