Lenalidomide and Low Dose Dexamethasone Versus Bortezomib, Lenalidomide and Low Dose Dexamethasone for Induction, in Patients With Previously Untreated Multiple Myeloma
Overview
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 440
- Locations
- 1
- Primary Endpoint
- comparison progression-free survival (PFS) in patients with newly diagnosed myeloma treated with lenalidomide plus low dose dexamethasone versus bortezomib plus lenalidomide and low dose dexamethasone
Overview
Brief Summary
This is a randomized phase III trial of CC-5013 (lenalidomide, NSC-703813) and low dose dexamethasone (LLD) versus bortezomib (PS-341, NSC-681239), lenalidomide and low dose dexamethasone (BLLD) for induction, in patients with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Lenalidomide
Lenalidomide/Low dose Dex (LLD)
Intervention: Lenalidomide/Low dose Dex (Drug)
Lenalidomide
Lenalidomide/Low dose Dex (LLD)
Intervention: Lenalidomide (Drug)
Bortezomib/Lenalidomide
Bortezomib/Lenalidomide/ Low dose Dex (BLLD)
Intervention: Bortezomib/Lenalidomide/ Low dose Dex (Drug)
Outcomes
Primary Outcomes
comparison progression-free survival (PFS) in patients with newly diagnosed myeloma treated with lenalidomide plus low dose dexamethasone versus bortezomib plus lenalidomide and low dose dexamethasone
Time Frame: Four years
Secondary Outcomes
No secondary outcomes reported