Myelodysplastic SyndromesPhase 3NCT00050843
A Study to Access the Safety/Efficacy of Thalidomide in the Treatment of Anemia in Patients With Myelodysplastic Syndromes
A Phase 3 study testing thalidomide in people with Myelodysplastic Syndromes, run by Celgene Corporation at 38 sites in United States.
Trial summary
The primary objective of the study is to determine the efficacy of thalidomide for the treatment of anemia in patients with myelodysplastic syndromes (MDS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- thalidomide
- How many people
- 220 participants
- Where
- 38 sitesUnited States
- Study dates
- Aug 2001to Feb 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Eligible patients must have a diagnosis of myelodysplastic syndrome
- Life expectancy of at least 6 months.
- Patients must be able to adhere to the study visit schedule and other protocol requirements.
- Patients must understand and voluntarily sign an informed consent document.
- Women of childbearing potential (WCBP) must agree to practice abstinence or to use TWO methods of contraception beginning 4 weeks prior to the start of study medication and throughout the course of treatment.
- Males must use barrier contraception when engaging in reproductive sexual activity with women of childbearing potential.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Northwest Medical Specialists
Arlington Heights, Illinois, 60004
Roswell Park Cancer Institute
Buffalo, New York, 14263
Oncology Associates
Cedar Rapids, Iowa, 52403
Oncology/Hematology Care Inc
Cincinnati, Ohio, 45246
Texas Oncology PA-BMT Center
Dallas, Texas, 75230
SMDC Health Systems
Duluth, Minnesota, 55805
Southeast Florida Hematology-Oncology
Fort Lauderdale, Florida, 33308
Florida Cancer Specialists
Fort Myers, Florida, 33901
Northwestern Carolina Hematology Oncology PA
Hickory, North Carolina, 28602
Jackson Oncology Associates PLLC
Jackson, Mississippi, 39202
Medical Oncology Associates
Kingston, Pennsylvania, 18704
Scripps Cancer Center
La Jolla, California, 93037
Lancaster Cancer Center LTD
Lancaster, Pennsylvania, 17605
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Memorial Sloan Kettering Cancer Ctr
New York, New York, 10021
VAMC Northport
Northport, New York, 11768
Whittingham Cancer Center
Norwalk, Connecticut, 06856
Comprehensive Cancer Centers of the Desert
Palm Springs, California, 92262
Hematology Oncology Associates of NJ
Paramus, New Jersey, 07652
MCP Hahnemann University
Philadelphia, Pennsylvania, 19129
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, 15224
Oregon Health & Science University
Portland, Oregon, 97201
Central Utah Medical Clinic
Provo, Utah, 84604
Desert Hematology Oncology Medical Group INC
Rancho Mirage, California, 92270
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester Cancer Center
Rochester, New York, 14642
South Shore Hem-Onc Assoc. PA
Rockville Centre, New York, 11570
Beaumont Cancer Center
Royal Oak, Michigan, 48073
InterMountain Hematology/Oncology
Salt Lake City, Utah, 84122
Swedish Cancer Institute
Seattle, Washington, 98104
Hematology Oncology Consultants Inc
St Louis, Missouri, 63136
Staten Island Unversity Hospital
Staten Island, New York, 10305
Summit Medical Group/Overlook Oncology Center
Summit, New Jersey, 07901
Westchester County Medical Center
Valhalla, New York, 10595
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
Buffalo Medical Group PC
Williamsville, New York, 14221
Wake Forest Univ School of Medicine
Winston-Salem, North Carolina, 27157-1082
Yakima Regional CancerCenter
Yakima, Washington, 98902
About this study
The primary objective of the study is to determine the efficacy of thalidomide for the treatment of anemia in patients with myelodysplastic syndromes (MDS).
- Conditions
- Myelodysplastic Syndromes
- Being tested
- thalidomide
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thalidomideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2002 (estimated)
- Study startAug 2001
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- Celgene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050843
- Sponsor's protocol ID
- THAL-MDS-001
- Status last verified
- May 2004
- First submitted
- 23 Dec 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Access the Safety/Efficacy of Thalidomide in the Treatment of Anemia in Patients With Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT00050843
- Acronym / sponsor ID
- THAL-MDS-001
- Conditions
- Myelodysplastic Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- Celgene CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Study completion
- Feb 2004
- First posted
- 24 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to determine the efficacy of thalidomide for the treatment of anemia in patients with myelodysplastic syndromes (MDS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thalidomide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing thalidomide in people with Myelodysplastic Syndromes, run by Celgene Corporation at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.