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IPH2101 in Multiple Myeloma
NCT00999830Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2009
- Primary completion
- Jun 2012
- Countries
- 1
- Sponsor
- Innate Pharma
- Modality
- Monoclonal Antibodies
- Drugs
- IPH 2101
- Conditions
- multiple myeloma (MM)
01
Overview
Phase 2, randomised, open-label trial of IPH 2101 in multiple myeloma (MM) (2 arms), sponsored by Innate Pharma. Primary endpoint: Rate of Patients Achieving a Response Based on M-protein or Free Light Chains at 2 years. Started Sep 2009; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
IPH 2101 0.2 mg/kg
One infusion of IPH2101 every 4 weeks at the dose of 0.2 mg/kg
IPH2101 2.0 mg/kg
One infusion of IPH2101 every 4 weeks at the dose of 2 mg/kg
03
Who it enrols
Patients with Multiple Myeloma who achieved a stable partial or very good partial response after first line therapy.
04
Endpoints
Primary
Rate of Patients Achieving a Response Based on M-protein or Free Light Chains
Secondary
Biological Activity of IPH2101 on Killer Immunogloblin Like Receptors (KIR) Occupancy
Safety Assessment
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