Thalidomide-Dexamethasone for Multiple Myeloma

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Celgene Corporation
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Thalidomide

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.