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Genasense + Thalidomide + Dexamethasone in Relapsed/Refractory Multiple Myeloma
NCT00049374Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2002
- Primary completion
- Jan 2006
- Countries
- 1
- Sponsor
- University of Maryland, Baltimore
- Modality
- Small Interfering RNA (siRNA), Modified DNA Oligonucleotides, Single-strand DNA
- Drugs
- oblimersen
- Conditions
- multiple myeloma (MM)
01
Overview
Phase 2, open-label, single-arm trial of oblimersen in multiple myeloma (MM), sponsored by University of Maryland, Baltimore. Primary endpoint: Complete and Partial Response Rates. Started Sep 2002; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Oblimersen + Thalidomide + Dexamethasone
Combination of oblimersen, thalidomide, and dexamethasone.
03
Who it enrols
Patients with relapsed/refractory multiple myeloma, measurable disease, ECOG 0-2, and adequate organ function. Excludes CNS involvement, active GVHD, and severe prior thalidomide reactions.
04
Endpoints
Primary
Complete and Partial Response Rates
Secondary
Time to Progression
Duration of Response
Toxicity
Correlation of Disease Response with Bcl-2 Levels
Disease-Free Survival
Overall Survival
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