Conditions: Smoldering Multiple Myeloma
Keywords: Smoldering Multiple Myeloma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the anti-tumor activity, safety and pharmacology of two dose regimens (0.2 and 2 mg/kg)of IPH2101 in patients with Smoldering Multiple Myeloma.

Detailed description:
This is a randomized Phase II, open label, multi-centre study, with two independent arms.

Patients receive 6 injections of IPH2101, at the dose of 0.2 mg/kg or 2 mg/kg (according to their randomization) administered over one hour infusion at four weeks intervals.

A patient whose disease achieves at least a minimal response to study treatment at any time during the initial period of 6 cycles can be treated with an additional period of treatment of 6 cycles.

Patients are followed 6 months after treatment completion or until a KIR occupancy level \< 30% (i.e if the time required for KIR desaturation was \> 6 months), whichever is longer.

Arms:
arm 1: 0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles arm 2: 2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles

Interventions: intervention 1: IPH2101
Intervention descriptions: intervention 1: 0.2 mg/Kg or 2mg/Kg, every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles

Protocol document: