Status:
COMPLETED
Evaluation of Activity, Safety and Pharmacology of IPH2101 a Human Monoclonal Antibody in Patients With Multiple Myeloma
Lead Sponsor:
Innate Pharma
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
- Residual disease considered as evaluable with:
- Quantifiable serum M-protein: ≥ 3 g/l, except for spike in the beta globulin area. In this particular case serum M-protein is considered quantifiable if ≥ 10g/l
- If serum M-protein is \< 3g/l, measurable involved Free Light Chains ≥ 100 mg/l and an abnormal Free Light chains ratio (\<0.26 or \> 1.65)
- 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 \< 200 mg /24h;
- Very good partial response according to the IMWG uniform response criteria with 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg/24h; furthermore the M-protein should spike in the gamma globulin area;
- Plateau phase is defined by :
- For patients with serum M-protein ≥ 3g/l: stable levels of M-protein in serum during at least 2 months checked on at least 3 consecutive samples, with the third evaluation performed within 4 weeks before study entry. Fluctuations of ± 25 % and ± 2 g/l in Serum M-protein levels are allowed.
- For Patients with serum M-protein \< 3g/l: stable levels Free Light Chains in serum during at least 2 months checked on at least 3 consecutive samples, with the third evaluation performed within 4 weeks before study entry. Fluctuations of ± 25 % of involved serum Free Light Chain are allowed.
- ECOG performance status of 0, 1 or 2.
- Clinical laboratory values at screening:
- Calculated creatinine clearance (according to MDRD) \> 50 ml/min
- Platelet \> 50 x 109 /l
- ANC \> 1 x 109 /l
- Bilirubin levels \< 1.5 ULN; ALT and AST \< 2.5 ULN
- 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.
- Signed inform consent obtained before any trial-related activities
Exclusion
- Age \< 18 years old or \> 75 years old
- Previous consolidation/ maintenance therapy by Imid (thalidomide, lenalidomid) or bortezomib within the last 2 months
- Treatment with chemotherapy, systemic corticosteroid within the previous 2 months
- Treatment with growth factors (EPO, G- or GM-CSF) within the previous 1 month
- Radiotherapy for bone or visceral lesion within the last 3 months
- Use of any investigational agent within the last 2 months
- Primary or associated amyloidosis
- Peripheral neuropathy of grade ≥ III according to the CTCAE of the NCI
- 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 despite treatment
- Current active infectious disease or positive serology for HIV, HCV or positive Hbs Antigen
- History of or current auto-immune disease
- Serious concurrent uncontrolled medical disorder
- History of other malignancy for less then 5 years (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma)
- History of allogenic hematopoietic cell or solid organ transplantation
- Pregnant or lactating women
- Any medical condition which is regarded by the investigator as incompatible with the study participation
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00999830
Start Date
September 1 2009
End Date
June 1 2013
Last Update
March 24 2016
Active Locations (9)
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1
C.H.R.U. de Caen - Hôpital Bretonneau
Caen, France, 14033
2
CHU Dijon
Dijon, France, 21079
3
CHRU Lille
Lille, France, 59037
4
Hôpital Dupuytren
Limoges, France, 87042