Thalidomide-Dexamethasone for Multiple Myeloma
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.
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.
-  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.