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Thalidomide-Dexamethasone for Multiple Myeloma

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma

Intervention: Thalidomide (Drug); Dexamethasone (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Donna M Weber, M.D., Study Chair, Affiliation: UT MD Anderson Cancer Center

Summary

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

Clinical Details

Official title: Thalidomide-Dexamethasone for Multiple Myeloma

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

Primary outcome: Response Rate

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information

UT MD Anderson Cancer Center website

Starting date: September 2001
Last updated: July 31, 2012

Page last updated: August 23, 2015

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