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
- 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
- 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.