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Sponsors and Collaborators: |
Yale University Kirin Pharma Company, Limited Celgene Corporation |
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 |
Myeloma |
Drug: Lenalidomide Biological: Monocyte derived DCs loaded with KRN7000 |
Phase I Phase II |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Multiple Myeloma |
ChemIDplus related topics: | Lenalidomide CC 5013 Ceramide KRN 7000 |
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: | August 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (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.
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
(b) Laboratory inclusion criteria obtained ≤ 1 month prior to registration:
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 | Not yet recruiting | ||||
New Haven, Connecticut, United States, 06520 |
Yale University |
Kirin Pharma Company, Limited |
Celgene Corporation |
Principal Investigator: | Madhav Dhodapkar, MD | Yale University |
Responsible Party: | Yale University School of Medicine ( Madhav Dhodapkar, M.D. ) |
Study ID Numbers: | 0712003357 |
First Received: | June 12, 2008 |
Last Updated: | June 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00698776 |
Health Authority: | United States: Food and Drug Administration |
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