NCT01217203

Study on the Safety, Anti-tumor Activity and Pharmacology of IPH2101 Combined With Lenalidomide in Patients With Multiple Myeloma Experiencing a First or Second Relapse

Multicenter Phase I Study on the Safety, Anti-tumor Activity and Pharmacology of IPH2101, a Human Monoclonal Anti-KIR, Combined With Lenalidomide in Patients With Multiple Myeloma Experiencing a First or Second Relapse

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Innate Pharma · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the clinical study is to evaluate, in patients who experience a first or second relapse of their multiple myeloma, the safety of escalating doses of IPH2101 combined with lenalidomide

Conditions

• Patients With Multiple Myeloma Experiencing a
• First or Second Relapse

Interventions

Type	Name	Description
DRUG	IPH2101 combined to lenalidomide	Dose level 1 : 0.2 mg/kg IPH2101(with Lenalidomide 10 mg/day) Dose level 2 : 0.2 mg/kg IPH2101(with Lenalidomide 25 mg/day) Dose level 3 : 1 mg/kg IPH2101(with Lenalidomide 25 mg/day) Dose level 4 : 2 mg/kg IPH2101(with Lenalidomide 25 mg/day) Extension cohort: 6 patients at the Maximum Tolerated Dose (MTD)

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-12-01
• Completion: 2014-02-01
• First posted: 2010-10-08
• Last updated: 2014-02-28

Locations

6 sites across 1 country: United States