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| Sponsor: | Innate Pharma |
|---|---|
| Information provided by (Responsible Party): | Innate Pharma |
| ClinicalTrials.gov Identifier: | NCT00999830 |
Purpose
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 tumor cells. This is different from many other treatments where chemicals are given to kill tumor cells.The primary objective of the study is to evaluate the clinical activity 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 stable partial or very good partial response (PR or VGPR).
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: IPH2101 Fully human anti-KIR monoclonal antibody |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 28 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: IPH 2101 0.2 mg/kg |
Drug: IPH2101 Fully human anti-KIR monoclonal antibody
One infusion of IPH2101 every 4 weeks
|
| Experimental: IPH2101 2.0 mg/kg |
Drug: IPH2101 Fully human anti-KIR monoclonal antibody
One infusion of IPH2101 every 4 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Residual disease considered as evaluable with:
Responses which are partial (PR and VGPR) and in plateau
Plateau phase is defined by :
Clinical laboratory values at screening:
Exclusion Criteria:
Abnormal cardiac status with any of the following
Contacts and Locations| France | |
| C.H.R.U. de Caen - Hôpital Bretonneau | |
| Caen, France, 14033 | |
| CHU Dijon | |
| Dijon, France, 21079 | |
| CHRU Lille | |
| Lille, France, 59037 | |
| Hôpital Dupuytren | |
| Limoges, France, 87042 | |
| Institut Paoli Calmettes | |
| Marseille, France, 13273 | |
| CHU Nancy | |
| Nancy, France, 54511 | |
| CHRU Nantes | |
| Nantes, France, 44093 | |
| Hôpital Saint Antoine | |
| Paris, France, 75012 | |
| Hopital Saint Louis | |
| Paris, France, 75010 | |
| Hopital Purpan | |
| Toulouse, France, 31059 | |
| C.H.R.U. de Tours | |
| Tours, France, 37044 | |
| Principal Investigator: | Michel ATTAL, MD | CHU Toulouse |
More Information
| Responsible Party: | Innate Pharma |
| ClinicalTrials.gov Identifier: | NCT00999830 History of Changes |
| Other Study ID Numbers: | IPH2101-201 |
| Study First Received: | October 21, 2009 |
| Last Updated: | March 2, 2012 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases |
Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Antibodies Immunoglobulins Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |