This is an open randomised phase II study evaluating the anti-tumour activity, safety and pharmacology of two dose regimens of IPH2101, a human monoclonal anti-KIR antibody, in patients with multiple myeloma in stable partial response after a first line therapy.
Development of new treatments for diseases such as multiple myeloma is a focus for research. The research being conducted is on treatment called Anti-KIR, which activates the body's own cells to kill tumor cells. This is different from many other treatments where chemicals are given to kill tumor cells.The primary objective of the study is to evaluate the clinical activity of two different dose regimens (0.2 mg/kg, leading to an intermittent saturation of NK receptors and 2mg/kg leading to a sustained saturation of NK receptors) of IPH2101 administered as a single agent in multiple myeloma patients who achieved, after the completion of any first line treatment, including conventional or high dose chemotherapies, a stable partial or very good partial response (PR or VGPR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
One infusion of IPH2101 every 4 weeks
C.H.R.U. de Caen - Hôpital Bretonneau
Caen, France
CHU Dijon
Dijon, France
CHRU Lille
Lille, France
Hôpital Dupuytren
Limoges, France
Rate of Patients Achieving a Response Based on M-protein or Free Light Chains
Response was defined: * In patients with a serum M-protein \> 5 g/l, as a reduction of at least 25% (minor response according to European society for Blood and Marrow Transplantation (EBMT)) from baseline of serum M-protein confirmed on two consecutive determinations at 4 weeks interval; * In patients with a serum M-protein ≤ 5 g/l and ≥ 3g/l, as a negative electrophoresis * In patients with serum M-protein \< 3 g/l but a measurable involved serum free light chains ≥ 100 mg/l and an abnormal Free Light Chains ratio (\<0.26 or \> 1.65), as a ≥ 50 % decrease in the difference between involved and uninvolved Free Light Chains levels.
Time frame: From the start of the treatment to the End of Study and during the post study follow up during 2 years according to standard practices
Biological Activity of IPH2101 on Killer Immunogloblin Like Receptors (KIR) Occupancy at End of Treatment
KIR-occupancy is a relative measure of the fraction of cell surface KIR that is occupied by the IPH2101 monoclonal antibody, and hence is unavailable for binding to HLA ligands.
Time frame: From the start up to the end of study (15 months)
Safety Assessment
Adverse Events, Serious Adverse Events, physical examination and biological changes.
Time frame: from screening visit to the End of Study (at each study visit)
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Institut Paoli Calmettes
Marseille, France
CHU Nancy
Nancy, France
Hopital Saint Louis
Paris, France
Hôpital Saint Antoine
Paris, France
C.H.R.U. de Tours
Tours, France