Thalidomide-Dexamethasone for Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00038090|
Recruitment Status : Completed
First Posted : May 29, 2002
Last Update Posted : August 1, 2012
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Thalidomide Drug: Dexamethasone||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Thalidomide-Dexamethasone for Multiple Myeloma|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||May 2005|
|Actual Study Completion Date :||May 2005|
|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
- Response Rate [ Time Frame: Baseline, with each course and monthly tests ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|