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Sponsors and Collaborators: |
Yale University Kyowa Hakko Kirin Company, Limited Celgene Corporation |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00698776 |
This is a single arm open label trial to test the tolerability of the combination of monocyte derived DCs loaded with KRN7000 (DC-KRN7000) and Lenalidomide (LEN) in patients with asymptomatic myeloma. Phase I component of the study will evaluate the optimal dose of LEN, with particular emphasis on safety. After an interim analysis of these data, a single dose level will be chosen for phase II component in additional patients.
Condition | Intervention | Phase |
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Myeloma |
Drug: Lenalidomide Biological: Monocyte derived DCs loaded with KRN7000 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Trial of Combination of Lenalidomide (Revlimid, LEN) and Autologous Mature Dendritic Cells Pulsed With α-Galactosyl Ceramide (α-GalCer; KRN7000) in Myeloma |
Estimated Enrollment: | 36 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Measurable disease as defined by one of the following:
≥10% plasma cells as measured on the bone marrow aspirate or bone marrow biopsy.
Exclusion Criteria:
Any of the following:
Contact: Madhav Dhodapkar, MD | 203-785-4144 | madhav.dhodapkar@yale.edu |
United States, Connecticut | |
Yale University School of Medicine | Recruiting |
New Haven, Connecticut, United States, 06520 |
Principal Investigator: | Madhav Dhodapkar, MD | Yale University |
Responsible Party: | Yale University School of Medicine ( Madhav Dhodapkar, M.D. ) |
Study ID Numbers: | 0712003357 |
Study First Received: | June 12, 2008 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00698776 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Immunoproliferative Disorders Immunologic Factors Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Adjuvants, Immunologic Vascular Diseases Lenalidomide |
Paraproteinemias Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders KRN 7000 Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Antineoplastic Agents Blood Protein Disorders Hematologic Diseases Physiological Effects of Drugs Adjuvants, Immunologic Lenalidomide Vascular Diseases |
Paraproteinemias Hemostatic Disorders Pharmacologic Actions Multiple Myeloma Neoplasms Hemorrhagic Disorders KRN 7000 Therapeutic Uses Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |