Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma

Inclusion Criteria

• SMM of any risk level according to a definition derived of the International Myeloma Working Group definition ( Br J Haematol 2003; 121: 749) : Serum M protein ≥ 3 g/dl , AND/OR Bone Marrow plasma cells ≥ 10 % with no evidence of end-organ damage (CRAB)
• (C)Absence of hypercalcemia : Ca 50 ml/min
• (A)Absence of anemia : Hb > 11 g/dl
• (B)Absence of lytic bone lesion on standard skeletal survey (MRI could be used if clinically indicated)
• Measurable disease defined as a disease with a serum M protein ≥ 1 g/dl
• No evidence of fatigue, recurrent infections or any clinical suspicion of MM
• Diagnosis of SMM confirmed on two consecutive assessments (ie fluctuation under 25% of serum protein level) performed with at least a 4 week interval.
• Age > 18 years or 1.5 ULN ; ALT and AST > 3 ULN (grade 1 NCI)
• Primary or associated amyloidosis
• Abnormal cardiac status with any of the following
• NYHA stage III or IV congestive heart failure
• myocardial infarction within the previous 6 months
• symptomatic cardiac arrhythmia requiring treatment or persisting despite appropriate treatment
• Current active infectious disease or positive serology for HIV, HCV or positive Hbs Antigen
• History of or current auto-immune disease
• History of other active malignancy within the past five years (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma).
• Serious concurrent uncontrolled medical disorder
• History of allograft or solid organ transplantation
• Pregnant or lactating women
• Any condition potentially hampering compliance with the study protocol and follow-up schedule