thalidomide-dexamethasone for multiple myeloma

Conditions: Multiple Myeloma

Summary: objective is to assess the activity of the combination of thalidomide and dexamethasone in patients with previously untreated multiple myeloma.

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 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.

Keywords: myeloma thalidomide thalomid dexamethasone decadron