Multiple myeloma MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Product Name: AntiKIR (1-7F9)
Product Code: IPH2101
Pharmaceutical Form: Solution for infusion
Current Sponsor code: IPH2101
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Sponsors
Innate Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) MM which initially required a systemic therapy and received a first line treatment, conventional doses of chemotherapies or high dose chemotherapy and an autologous transplantation of hematopoietic cells, followed or not by a consolidation treatment. 2) Residual disease considered as evaluable with: - Quantifiable serum M-protein 3) Responses which are partial (PR and VGPR) and in plateau - Partial response should meet the IMWG uniform response criteria: a = 50% reduction from value of serum M-protein before the first line chemotherapy treatment and a reduction in 24h urinary M protein by = 90% or to 50 ml/min - Platelet > 50 x 109 /l - ANC > 1 x 109 /l - Bilirubin levels =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Age 75 years old 2) Previous consolidation/ maintenance therapy by Imid (thalidomide, lenalidomid) or bortezomib within the last 2 months 3) Treatment with chemotherapy, systemic corticosteroid within the previous 2 months 4) Treatment with growth factors (EPO, G- or GM-CSF) within the previous 1 month 5) MM in VGPR with a monoclonal spike in the beta globulin area 6) Radiotherapy for bone or visceral lesion within the last 3 months 7) Use of any investigational agent within the last 2 months 8) Primary or associated amyloidosis 9) Peripheral neuropathy of grade = III according to the CTCAE of the NCI 10) Abnormal cardiac status with any of the following a) NYHA stage III or IV congestive heart failure b) myocardial infarction within the previous 6 months c) symptomatic cardiac arrhythmia despite treatment 11) Current active infectious disease or positive serology for HIV, HCV or positive Hbs Antigen 12) History of or current auto-immune disease 13) Serious concurrent uncontrolled medical disorder 14) History of other malignancy (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma) 15) History of allogenic hematopoietic cell or solid organ transplantation 16) Pregnant or lactating women 17) Any medical condition which is regarded by the investigator as incompatible with the study participation 18) Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the clinical activity, measured by M-protein serum and urine levels, 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 partial or very good partial response (PR or VGPR), stable for at least 2 months. ;Secondary Objective: The secondary objectives are: o To confirm the safety profile of the dose and administration schedules of IPH2101 in this population; o To assess PK of two different dose regimens of IPH2101 o To evaluate the biological activity of IPH2101 on: - KIR occupancy - NK cell phenotype - NK cell function - Cytokine release o To confirm the absence of immunogenicity of IPH2101 o To document per study and post study efficacy parameters until 2 years after the end of study : - Overall Survival (OS) - Duration of response (DOR) - Progression free Survival (PFS) and Time to Progression (TTP) ;Primary end point(s): M Protein will be measured in serum and urine: o At Screening o Every 4 weeks during the study period from V1-day1 to End of Study Post study follow up: then every 3 months during 2 years according to standard practices The primary end point will be the rate of patients achieving a response based on M- Protein levels in serum and urine sustained for at least one month. Response will be defined: o In patients with a serum M-protein > 5 g/l, as a reduction of at least 25% (minor response according to EBMT Appendix VI) from baseline of serum M-protein confirmed on two consecutive determinations at 4 weeks interval; o In patients with a serum M-protein = 5 g/l, as a negative electrophoresis In any case, a reduction = 50% or a reduction to < 200mg/ 24h in 24h urine M-protein is required. | — |
Countries
France
Outcome results
None listed