S0232 Dexamethasone With or Without Lenalidomide in Treating Patients With Previously Untreated Stage I, Stage II, or Stage III Multiple Myeloma
NCT00064038 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198
Last updated 2015-03-25
Summary
RATIONALE: Drugs used in chemotherapy such as dexamethasone use different ways to stop cancer cells from dividing so they stop growing or die. Lenalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether dexamethasone is more effective with or without lenalidomide in treating multiple myeloma.
PURPOSE: This randomized phase III trial is studying dexamethasone and lenalidomide to see how well they work compared to dexamethasone alone in treating patients with previously untreated stage I, stage II, or stage III multiple myeloma.
Conditions
- Multiple Myeloma
- Plasma Cell Neoplasm
Interventions
- DRUG
-
Given orally
- DRUG
-
Given orally
- OTHER
-
placebo
Given orally
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
SWOG Cancer Research Network
lead NETWORK
Principal Investigators
-
Jeffrey A. Zonder, MD · Barbara Ann Karmanos Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-11-30
- Primary Completion
- 2008-10-31
- Completion
- 2012-05-31
Countries
- United States
Study Locations
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