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Sponsors and Collaborators: |
Dartmouth-Hitchcock Medical Center Celgene Corporation |
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Information provided by: | Dartmouth-Hitchcock Medical Center |
ClinicalTrials.gov Identifier: | NCT00665652 |
The purpose of the study is to learn about the effects of the drug, lenalidomide (Revlimid®), on neuropathy (damage to the nerves that affect feelings and strength) associated with Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS).
Condition | Intervention | Phase |
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Neuropathy Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS) |
Drug: Lenalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Trial of Lenalidomide as a Treatment for Neuropathy Associated With Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS) |
Estimated Enrollment: | 30 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 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:
Exclusion Criteria:
Contact: Tracy L. Ostler, BS, CCRP | 603-650-4145 | Tracy.L.Ostler@Hitchcock.org |
United States, New Hampshire | |
Dartmouth-Hitchcock Medical Center | Recruiting |
Lebanon, New Hampshire, United States, 03756 | |
Contact: Tracy L. Ostler, BS 603-650-4145 Tracy.L.Ostler@Hitchcock.org | |
Principal Investigator: Elijah W. Stommel, MD, PhD |
Principal Investigator: | Elijah W. Stommel, MD, PhD | Dartmouth-Hitchcock Medical Center |
Responsible Party: | Dartmouth-Hitchcock Medical Center ( Elijah Stommel, MD, PhD ) |
Study ID Numbers: | RV-PN-PI-235 |
Study First Received: | April 22, 2008 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00665652 |
Health Authority: | United States: Institutional Review Board |
Neuropathy Nonmalignant Monoclonal Gammopathy of Undetermined Significance (MGUS) |
Immunoproliferative Disorders Hematologic Diseases Blood Protein Disorders Lenalidomide |
Monoclonal Gammopathies, Benign Paraproteinemias Monoclonal gammopathy of undetermined significance |
Immune System Diseases Antineoplastic Agents Therapeutic Uses Hypergammaglobulinemia Pharmacologic Actions |