Open randomised phase II study evaluating the anti-tumour activity, safety and pharmacology of two different dose regimens of IPH 2101, a human monoclonal anti-KIR antibody, in patients with multiple myeloma in stable partial response after a first line therapy
- Conditions
- Multiple myelomaMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma
- Registration Number
- EUCTR2009-012136-33-FR
- Lead Sponsor
- Innate Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 42
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 < 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 stable levels of M protein in serum checked 4 weeks apart on at least 3 consecutive samples.
Fluctuations ± 1 week in sampling and ± 5 % in M protein levels are allowed.
4) ECOG performance status of 0, 1 or 2
5) 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 (grade 1 NCI)
6) 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.
7) Signed inform consent obtained before any trial-related activities
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1) Age < 18 years old or > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method