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

Exclusion Criteria

• •1. Previous treatment having a proven or potential impact on myelomatous cells proliferation or survival (including IMiDs or proteasome inhibitors, conventional chemotherapies within the last 5 years, steroids within the last month prior to enrolment). Previous bisphosphonates started less than 3 months prior to enrolment.
• •2. Use of any investigational agent within the last 3 months
• •3. Clinical laboratory values at screening
• •* Platelet \< 75 x 10\^9 /l
• •* ANC \< 1.5 x 10\^9 /l
• •* Bilirubin levels \>1.5 ULN ; ALT and AST \> 3 ULN (grade 1 NCI)
• •4. Primary or associated amyloidosis
• •5. Abnormal cardiac status with any of the following
• •1. NYHA stage III or IV congestive heart failure
• •2. myocardial infarction within the previous 6 months
• •3. symptomatic cardiac arrhythmia requiring treatment or persisting despite appropriate treatment
• •6. Current active infectious disease or positive serology for HIV, HCV or positive Hbs Antigen
• •7. History of or current auto-immune disease
• •8. History of other active malignancy within the past five years (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma).
• •9. Serious concurrent uncontrolled medical disorder
• •10. History of allograft or solid organ transplantation
• •11. Pregnant or lactating women
• •12. Any condition potentially hampering compliance with the study protocol and follow-up schedule