Lenalidomide Safety/Efficacy in Myelodysplastic Syndromes (MDS) Associated With a Deletion (Del)(5q) Cytogenetic Abnormality
Public ClinicalTrials.gov record NCT00065156. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Single-arm, Open-label Study of the Efficacy and Safety of Lenalidomide Monotherapy in Red Blood Cell Transfusion-dependent Subjects With Myelodysplastic Syndromes Associated With a Del(5q) Cytogenetic Abnormality.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is a multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk Myelodysplastic Syndromes (MDS) associated with a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of the first day of lenalidomide treatment. Subjects will receive lenalidomide in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement is documented. Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments.
Study identification
- NCT ID
- NCT00065156
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 148 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 1, 2003 (Actual)
- Primary completion
- Aug 1, 2008 (Actual)
- Completion
- Aug 1, 2008 (Actual)
- Last update posted
- Nov 19, 2019
2003 – 2008
United States locations
- U.S. sites
- 31
- U.S. states
- 17
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Cancer Center | Scottsdale | Arizona | 85258 | — |
| Mayo Clinic | Scottsdale | Arizona | 85259 | — |
| Arizona Cancer Center | Tucson | Arizona | 85724-5024 | — |
| Desert Hematology & Oncology Medical Group | Rancho Mirage | California | 92270 | — |
| Stanford University Medical Center | Stanford | California | 94305-5750 | — |
| Mayo Clinic | Jacksonville | Florida | 32224 | — |
| Cancer & Blood Disease Center | Lecanto | Florida | 34461 | — |
| University of Miami Sylvester Comp Cancer Center | Miami | Florida | 33136 | — |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612-9497 | — |
| Northwest Georgia Oncology - Wellstar Cancer Research | Marietta | Georgia | 30060 | — |
| Rush-Presbyterian- St. Luke's Medical Center | Chicago | Illinois | 60612 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637-1470 | — |
| Midwest Cancer Research Group | Skokie | Illinois | 60077 | — |
| Johns Hopkins Oncology Center | Baltimore | Maryland | 21287-8963 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115-6084 | — |
| Wayne State University School of Medicine | Detroit | Michigan | 48201-2097 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-7680 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| New York Hospital-Cornell | New York | New York | 10021-0034 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021-6007 | — |
| Mt. Sinai Medical Center | New York | New York | 10029 | — |
| University of Rochester- James P. Wilmot Cancer Center | Rochester | New York | 14642 | — |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157-1082 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Oregon Health & Science University | Portland | Oregon | 97201 | — |
| Kaiser Permanente Northwest Region | Portland | Oregon | 97227 | — |
| Western Pennsylvania Cancer Institute | Pittsburgh | Pennsylvania | 15224 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-4417 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00065156, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 19, 2019 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00065156 live on ClinicalTrials.gov.