Thalidomide-Dexamethasone for Multiple Myeloma

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00038090

Collaborator

Celgene Corporation (Industry)

Enrollment

Location

Arm

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Thalidomide Drug: Dexamethasone	Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

83 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Thalidomide-Dexamethasone for Multiple Myeloma

Study Start Date :

Jun 1, 2000

Actual Primary Completion Date :

May 1, 2005

Actual Study Completion Date :

May 1, 2005

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Thalidomide + Dexamethasone

Drug: Thalidomide

100 mg capsules by mouth daily each evening

Other Names:

Thalomid

Drug: Dexamethasone

20 mg/m^2 taken by mouth each morning on days 1-4, 9-12 and 17-20.

Other Names:

Decadron

Outcome Measures

Primary Outcome Measures

Response Rate [Baseline, with each course and monthly tests]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.