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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | May 21, 2007 | ||||||||||||
| Last Updated Date | August 31, 2009 | ||||||||||||
| Start Date ICMJE | May 2007 | ||||||||||||
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
To determine the safety and tolerability of human Anti-KIR (1-7F9), a fully human mAb, in subjects with relapsed or refractory multiple myeloma (MM) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
To determine the safety and tolerability of human Anti-KIR (1-7F9), a fully human mAb, in subjects with relapsed or refractory multiple myeloma (MM) [ Time Frame: 1 year ] | ||||||||||||
| Change History | Complete list of historical versions of study NCT00552396 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||||||
| Brief Title ICMJE | An Open-label, Dose-escalation Safety and Tolerability Trial Assessing Anti-KIR (1-7F9) in Subjects With Multiple Myeloma | ||||||||||||
| Official Title ICMJE | An Open-label, Dose-escalation Safety and Tolerability Trial Assessing Multiple Dose Administrations of Anti-KIR (1-7F9) Human Monoclonal Antibody in Subjects With Multiple Myeloma | ||||||||||||
| Brief Summary | 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 (1-7F9), 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 purpose of the study is to determine a safe dose of Anti-KIR (1-7F9) to administer in humans and to gain information about its effectiveness in the treatment of multiple myeloma. |
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| Detailed Description | Trial Design: The trial is an open-label, dose-escalation trial to determine the safety and tolerability of Anti-KIR (1-7F9) in subjects with relapsed or refractory multiple myeloma. A 3+3 design will be employed for the first dosing cycle at each dose level. The 7 planned dose levels are 0.0003 mg/kg, 0.003 mg/kg, 0.015 mg/kg, 0.075 mg/kg, 0.3 mg/kg, 1.0 mg/kg and 3.0 mg/kg. The subjects will receive up to a total of 4 administrations of Anti-KIR (1-7F9) with a dosing interval between each administration of 4 weeks. Safety, toxicity, PK and PD obtained in the first 4 weeks after dosing per group will be the basis for dose-escalation decisions. There will be follow-up visits every week the one month after the first administration and every two weeks following the second, third and fourth administrations. After the last administration there will be follow-up visits every month until KIR occupancy is no longer detected. |
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| Study Phase | Phase I | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||||||||||
| Condition ICMJE | Refractory Multiple Myeloma | ||||||||||||
| Intervention ICMJE | Drug: Anti-KIR (1-7F9) | ||||||||||||
| Study Arms / Comparison Groups | |||||||||||||
| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||||||
| Estimated Completion Date | May 2011 | ||||||||||||
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
3a. One prior therapy for multiple myeloma, Measurable disease, as defined by persistent presence of serum and/or urine monoclonal protein or abnormal serum free light chain ratio following the prior treatment. a. Only for the last seven patients enrolled into the cohort 7 or MTD. 4. Full recovery from acute toxicities of prior anti-MM therapies. 5. Peripheral blood NK cells (Absolute CD16, 56)≥ 0.05 x 109/L (50/mm3) 6. Detectable binding of Anti-KIR (1-7F9) to subject NK cells 7. Age ≥ 18 years 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 9. Clinical laboratory values at screening:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00552396 | ||||||||||||
| Responsible Party | Marc Marzetto, MD/Director, Clinical Program Development, Innate Pharma | ||||||||||||
| Study ID Numbers ICMJE | IPH2101-103 | ||||||||||||
| Study Sponsor ICMJE | Innate Pharma | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
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| Information Provided By | Innate Pharma | ||||||||||||
| Verification Date | January 2009 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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