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Thalidomide-Dexamethasone for Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038090
First received: May 28, 2002
Last updated: July 31, 2012
Last verified: July 2012

May 28, 2002
July 31, 2012
September 2001
May 2005   (final data collection date for primary outcome measure)
Response Rate [ Time Frame: Baseline, with each course and monthly tests ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00038090 on ClinicalTrials.gov Archive Site
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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.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: Thalidomide
    100 mg capsules by mouth daily each evening
    Other Name: Thalomid
  • Drug: Dexamethasone
    20 mg/m^2 taken by mouth each morning on days 1-4, 9-12 and 17-20.
    Other Name: Decadron
Experimental: Thalidomide + Dexamethasone
Interventions:
  • Drug: Thalidomide
  • Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
May 2005
May 2005   (final data collection date for primary outcome measure)
  • 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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00038090
ID00-070
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Celgene Corporation
Study Chair: Donna M Weber, M.D. UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP