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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Celgene Corporation |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00360880 |
Participants will receive a single dose of CC-5013 on Day -7. Baseline tests (blood and urine) will be performed to characterize the drug PK profile. Hematologic response and a bone marrow aspirate and biopsy will be evaluated after 16 weeks of CC-5013 monotherapy for continued participation into the combined treatment phase. Subjects will continue treatment with CC-5013 and recombinant human erythropoietin (rhu-EPO) administered weekly. In the monotherapy and combined treatment phases, visits will occur every 28 days and sequential measurements of safety and efficacy will be performed.
Condition | Intervention |
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Myelodysplastic Syndrome (MDS) |
Drug: Lenalidomide (CC-5013) Drug: Erythropoietin (rhu-EPO) |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Pharmacokinetic and Pharmacodynamic Study of Oral CC-5013 (Lenalidomide; Revlimid) in Subjects With Low- or Intermediate-1-Risk Myelodysplastic Syndromes |
Estimated Enrollment: | 50 |
Study Start Date: | December 2004 |
During the screening process providing an adequate bone marrow aspirate sample will be necessary for you to be eligible to participate in this study. In the PK phase of the study, participants will receive a single dose of CC-5013 on Day -7. Baseline tests (blood and urine) will be performed to characterize the drug PK profile.
In the monotherapy phase of the study, visits will occur every 28 days and sequential measurements of safety and efficacy will be performed. All subjects will return to the Moffitt Clinic on Day 14 for an overnight fast to obtain post dose blood (for CC-5013 plasma levels) and urine samples. Hematologic response and a bone marrow aspirate and biopsy will be evaluated after 16 weeks of CC-5013 monotherapy for continued participation.
In the combined treatment phase subjects will continue treatment with CC-5013 and recombinant human erythropoietin (rhu-EPO) administered weekly. Study visits will occur every 28 days and sequential measurements of safety and efficacy will be performed. Subjects will be assessed for erythroid response after 8 weeks of combination therapy. All subjects will complete off-study evaluations including a BM aspirate and biopsy with cytogenetic analysis and laboratory studies.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following lab abnormalities:
Contact: Jennifer Paleveda | 813-745-5413 | jennifer.paleveda@moffitt.org |
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Sub-Investigator: Lodovico Balducci, MD | |
Sub-Investigator: Benjamin Djulbegovic, MD | |
Sub-Investigator: Martine Extermann, MD | |
Sub-Investigator: Hussain I Saba, MD, PhD | |
Sub-Investigator: Eduardo Sotomayor, MD | |
Sub-Investigator: Jeffrey Lancet, MD | |
Sub-Investigator: Bhavesh Balar, MD | |
Sub-Investigator: Lubomir Sokol, MD | |
Sub-Investigator: Sara M Tinsley, ARNP | |
Sub-Investigator: Katherine G Low, ARNP, AOCN |
Principal Investigator: | Alan List, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
Study ID Numbers: | MCC-13937 |
Study First Received: | August 3, 2006 |
Last Updated: | August 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00360880 |
Health Authority: | United States: Food and Drug Administration |
Myelodysplastic syndrome (MDS) Pharmacokinetic profile Lenalidomide Rhu-Epo |
Epoetin Alfa Myelodysplastic syndromes Preleukemia Precancerous Conditions Hematologic Diseases |
Myelodysplasia Myelodysplastic Syndromes Lenalidomide Bone Marrow Diseases |
Neoplasms Pathologic Processes Disease Antineoplastic Agents |
Therapeutic Uses Syndrome Pharmacologic Actions |