Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma
Condition: Smoldering Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Smoldering Multiple Myeloma
Intervention: IPH2101
Intervention description: 0.2 mg/Kg or 2mg/Kg, every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Smoldering Multiple Myeloma

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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 < 10.5 mg/dl

               -  (R)Absence of renal failure : creatinine < 2mg/dl (177 μmol/l) or calculated
                  creatinine clearance(according to MDRD) > 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)

          2. Measurable disease defined as a disease with a serum M protein ≥ 1 g/dl

          3. No evidence of fatigue, recurrent infections or any clinical suspicion of MM

          4. Diagnosis of SMM confirmed on two consecutive assessments (ie fluctuation under 25% of
             serum protein level) performed with at least a 4 week interval.

          5. Age > 18 years or < 75 years

          6. ECOG performance status of 0 or 1

          7. Male or female patient who accepts and is able to use recognised effective
             contraception (oral contraceptives, IUCD, barrier method of contraception in
             conjunction with spermicidal jelly) throughout the study when relevant

          8. Informed consent signed by the patient

        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