Open Label Study of the Anti Insulin-like Growth Factor 1 Receptor (IGF-1R) Monoclonal Antibody, AVE1642, as Single Agent (Dose Escalation, Part 1) and in Combination With VelcadeĀ® (Combination, Part 2) in Patients With Recurrent, Refractory Multiple Myeloma (MM)
Interventional
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
definition of the Selected Dose (SD)
Selected Dose will be based on the AVE1642 clearance /IGF-1 plateaus and on safety (less than 33% of pts with dose limiting toxicity (DLT)when administered as single agent in a first part of the study. The safety and pharmacokinetics of the regimen in combination with bortezomib will be assessed in the second part of the study
2 years
Yes
Clinical Sciences & Operations
Study Director
Sanofi
France: Institutional Ethical Committee
TED6420
NCT01233895
September 2006
September 2008
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