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TaCyDex and V-MP/VAMP in Refractary or Relapsed Multiple Myeloma
NCT00652041Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2007
- Primary completion
- Jan 2010
- Countries
- 1
- Sponsor
- Fundación PETHEMA
- Modality
- Small Molecules, Modified Peptides
- Conditions
- multiple myeloma (MM)
01
Overview
Phase 4, open-label, single-arm trial of bortezomib and thalidomide in multiple myeloma (MM), sponsored by Fundación PETHEMA. Primary endpoints: Efficacy (Response Rate) at 1 year and Efficacy (Response Duration) at 1 year. Started Jan 2007; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Sequential Treatment
Bortezomib-based induction followed by Thalidomide-based maintenance
03
Endpoints
Primary
Efficacy (Response Rate)
Efficacy (Response Duration)
Secondary
Response Type by Initial Situation
Response Duration Analysis
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