Multiple Myeloma Clinical Trial
Official title:
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 Velcade® (Combination, Part 2) in Patients With Recurrent, Refractory Multiple Myeloma (MM)
Primary Objectives:
Study Part 1: Determine the selected dose of AVE1642 administered every 3 weeks based on
pharmacokinetic (PK) (Clearance of AVE1642), pharmacodynamic (PD) (insulin-like growth
factor 1 [IGF-1] serum level) parameters, and eventual dose limiting toxicities (DLTs) in
patients with recurrent, refractory multiple myeloma (MM).
Study Part 2: Assess the safety of the combination of the selected dose of AVE1642 with the
recommended dose of Velcade®.
Secondary Objectives :
Study Part 1:
- To assess the safety profile: type, incidence and intensity of drug related adverse
events (AEs)
- To assess the biological activity of AVE1642 (saturation of the receptors and
down-regulation) on malignant plasma cells and on peripheral blood mononuclear cells
(PBMC) and granulocytes
- To assess the biological activity of AVE1642 on the signalization pathway of the IGF-1
system (phosphorylated akt [pAkt], phosphorylated erk [pErk]) on malignant plasma cells
when technically possible
- To define PK profile of AVE1642, and its PD effects on serum IGF 1, GF 2 and IGFBP-3
- To assess clinical efficacy (complete response [CR], partial response [PR], minimal
response [MR] and stabilization) based on the European group for Blood and Marrow
Transplantation (EBMT) criteria, when possible
- To assess potential immunogenicity by detection of human antihumanized antibodies
(HAHA) anti-AVE1642
Study Part 2:
- To detect any PK or PD interaction between AVE1642 and Velcade®
- To assess clinical efficacy (CR, PR, MR, no change [NC]) according to EBMT criteria
when appropriate
- To assess biological activity of AVE1642 in combination with Velcade® on malignant
plasma cells collected from bone marrow aspirates: saturation and down-regulation of
the insulin-like growth factor 1 receptor (IGF-1R) and activity on the signalization
pathway of the IGF-1 system (pAkt, pErk) when feasible
- To detect immunogenicity reaction (HAHA)
- To characterize PK and PD profile of a low dose (0.5 mg/kg) of AVE1642 expected to be
non biologically active
n/a
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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