Smoldering Multiple Myeloma Clinical Trial
Official title:
Multicenter Phase II Study on the Anti-tumor Activity, Safety and Pharmacology of Two Dose Regimens of IPH2101, a Fully Human Monoclonal Anti KIR Antibody, in Patients With Smoldering Multiple Myeloma (KIRMONO)
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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