Expired Study
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Houston, Texas 77030


Purpose:

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


Study summary:

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.


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.


Study is Available At:


Original ID:

ID00-070


NCT ID:

NCT00038090


Secondary ID:


Study Acronym:


Brief Title:

Thalidomide-Dexamethasone for Multiple Myeloma


Official Title:

Thalidomide-Dexamethasone for Multiple Myeloma


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

M.D. Anderson Cancer Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

83


Enrollment Type:

Actual


Overall Contact Information

Official Name:Donna M Weber, M.D.
Study Chair
UT MD Anderson Cancer Center

Study Dates

Start Date:June 2000
Completion Date:May 2005
Completion Type:Actual
Primary Completion Date:May 2005
Primary Completion Type:Actual
Verification Date:October 2018
Last Changed Date:October 30, 2018
First Received Date:May 28, 2002

Study Outcomes

Outcome Type:Primary Outcome
Measure:Response Rate
Time Frame:Baseline, with each course and monthly tests
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Thalidomide
Description:100 mg capsules by mouth daily each evening
Arm Name:Thalidomide + Dexamethasone
Other Name:Thalomid
Intervention Type:Drug
Name:Dexamethasone
Description:20 mg/m^2 taken by mouth each morning on days 1-4, 9-12 and 17-20.
Arm Name:Thalidomide + Dexamethasone
Other Name:Decadron

Study Arms

Study Arm Type:Experimental
Arm Name:Thalidomide + Dexamethasone

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:M.D. Anderson Cancer Center
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Celgene Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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