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Home > "T" Clinical Trials Conditions > Thalidomide-Dexamethasone for Multiple Myeloma  Thalidomide-Dexamethasone for Multiple Myeloma
Thalidomide-Dexamethasone for Multiple Myeloma
For Condition: Multiple Myeloma
Status: Suspended
Sponsor(s): M.D. Anderson Cancer Center , Celgene Corporation
Synopsis: In patients with previously untreated multiple myeloma to assess the activity of the combination of thalidomide and dexamethasone.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: - Previously untreated patients with symptomatic or progressive asymptomatic multiple myeloma. Criteria for progression among patients with asymptomatic disease include new lytic bone lesions, rise of serum myeloma protein to >5.0 gm/dl or fall of Hgb to <10.5 gm/dl. - Overt infection or unexplained fever should be resolved before treatment or treated concurrently with antibiotics. - Patients must provide written informed consent indicating that they are aware of the investigational nature of this study. - Patients with idiopathic monoclonal gammopathy or stable asymptomatic myeloma are ineligible. - Patients whose only prior therapy has been with local radiotherapy or alpha interferon are eligible. - Patients treated with steroids in order to stabilize disease within 60 days prior to enrollment are eligible. - Patients exposed to longer periods of high-dose glucocorticoid, or with any exposure to thalidomide or alkylating agent are ineligible.
Total Enrollment: 78
Location and Contact Information:
University of Texas M. D. Anderson Cancer Center
Houston, Texas,
United States
Additional Information:
Study ID Numbers: ID00-070;
Study Start Date: September 2001
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038090
Other Multiple Myeloma Studies:
1. Phase I Study of SU006668 in Patients With Advanced Solid Tumors
2. Tipifarnib in Treating Patients With Advanced Hematologic Cancer
3. Mycophenolate Mofetil, Tacrolimus, Daclizumab, and Donor Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
4. Thalidomide for Multiple Myeloma
5. Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
Related Studies:
Other Multiple Myeloma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Thalidomide-Dexamethasone for Multiple Myeloma
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