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| Sponsored by: |
Innate Pharma |
|---|---|
| Information provided by: | Innate Pharma |
| ClinicalTrials.gov Identifier: | NCT00552396 |
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 (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.
| Condition | Intervention | Phase |
|---|---|---|
|
Refractory Multiple Myeloma |
Drug: Anti-KIR (1-7F9) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Relapse or progression after at least one prior systemic treatment regimen for MM as evidenced by ≥ 25% increase in the M-protein as compared to the best response from the previous treatment regimen. 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.
Clinical laboratory values at screening:
Exclusion Criteria:
Contacts and Locations| Contact: Marc Marzetto, MD | +33 (0)9 77 40 40 41 | marc.marzetto@innate-pharma.fr |
| Contact: Marlena Griffin | (512) 904-9492 | marlena.griffin@aaipharma.com |
| United States, Indiana | |
| Indiana University Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: Sherif Farag, MD, PhD | |
| Sub-Investigator: Rafat Abonour, MD | |
| Sub-Investigator: Attaya Suvannasankha, MD | |
| United States, Ohio | |
| Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Principal Investigator: Don M Benson, MD, PhD | |
| Sub-Investigator: John C Byrd, MD | |
| Sub-Investigator: Craig C Hofmeister, MD | |
| United States, Texas | |
| Cancer Therapy Research Center at UTHSCSA | Recruiting |
| San Antonio, Texas, United States, 78229-4427 | |
| Principal Investigator: Swaminathan Padmanabhan, MD | |
| Sub-Investigator: Andrew J Brenner, MD | |
| Principal Investigator: | Sherif Farag, MD, PhD | Indiana University |
| Principal Investigator: | Don Benson, Jr., MD, PhD | Division of Haematology/Oncology - Ohio State University |
| Principal Investigator: | Swaminathan Padmanabhan, MD | CTRC Institute for Drug Development - University of Texas at San Antonio |
More Information
| Responsible Party: | Innate Pharma ( Marc Marzetto, MD/Director, Clinical Program Development ) |
| Study ID Numbers: | IPH2101-103 |
| Study First Received: | May 21, 2007 |
| Last Updated: | June 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00552396 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
refractory multiple myeloma Anti-KIR (1-7F9 |
|
Immunoproliferative Disorders Immunologic Factors Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Antibodies, Monoclonal Antibodies Hemorrhagic Disorders Lymphoproliferative Disorders Immunoglobulins Neoplasms, Plasma Cell |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Blood Protein Disorders Hematologic Diseases Physiological Effects of Drugs Vascular Diseases Paraproteinemias |
Hemostatic Disorders Pharmacologic Actions Multiple Myeloma Antibodies, Monoclonal Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |