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Thalidomide-Dexamethasone for Multiple Myeloma

Phase 2/Phase 3
Not Enrolling
Multiple Myeloma

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Trial Information

Thalidomide-Dexamethasone for 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.

Inclusion 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Time Frame:

Baseline, with each course and monthly tests

Safety Issue:


Principal Investigator

Donna M Weber, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2001

Completion Date:

May 2005

Related Keywords:

  • Multiple Myeloma
  • Myeloma
  • Thalidomide
  • Thalomid
  • Dexamethasone
  • Decadron
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



University of Texas M. D. Anderson Cancer Center Houston, Texas  77030