Phase 2
N=27
Evaluation of Activity, Safety and Pharmacology of IPH2101 a Human Monoclonal Antibody in Patients With Multiple Myeloma
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00999830 ↗Enrolled (actual)
27
Serious AEs
7.4%
Results posted
Mar 2016
Primary outcome: Primary: Rate of Patients Achieving a Response Based on M-protein or Free Light Chains — 0; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IPH2101 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Innate Pharma
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Patients Achieving a Response Based on M-protein or Free Light Chains |
0; 1 | — |
| SECONDARY Biological Activity of IPH2101 on Killer Immunogloblin Like Receptors (KIR) Occupancy at End of Treatment |
80.5; 96.8 | — |
| SECONDARY Safety Assessment |
14; 11 | — |
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 myeloma in stable partial response after a first line therapy.
Eligibility Criteria
Inclusion Criteria
- 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 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 50 ml/min
- Platelet > 50 x 109 /l
- ANC > 1 x 109 /l
- Bilirubin levels 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
Data sourced from ClinicalTrials.gov (NCT00999830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.