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Lenalidomide in Subjects With intermediate2 or High MDS Associated With a Deletion (DEL) 5q [31]

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by Groupe Francophone des Myelodysplasies.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: January 18, 2007
Last Update Posted: March 12, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Groupe Francophone des Myelodysplasies
We are evaluating the incidence of significant hematological response, according to IWG criteria including CR, PR or, major HI, (HI-E, Hl-N,or Hl- P), and cytogenetic response of patients diagnosed with intermediate-2 or high-risk (International Prognostic Scoring System [IPSS]) MDS with a deletion (del) 5q[31]

Condition Intervention Phase
Myelodysplastic Syndromes Drug: LENALIDOMIDE Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of the Efficacy and Safety of Lenalidomide in Adult Subjects With Intermediate-2-or Higt Risk Myelodysplastic Syndrome(MDS) Associated With a Deletion (DEL) 5q [31]

Resource links provided by NLM:

Further study details as provided by Groupe Francophone des Myelodysplasies:

Primary Outcome Measures:
  • Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement

Estimated Enrollment: 49
Study Start Date: October 2006
Estimated Study Completion Date: October 2008
Detailed Description:

Subjects meeting all inclusion and exclusion criteria will receive lenalidomide

lenalidomide will be administered at 10 mg (two 5 mg capsules) once daily on Days 1–21, every 4 weeks.

Bone marrow aspirate (baseline and during the course of the study at week 8, 16, 32, 52 and when clinically indicated/for assessment of disease progression) evaluations

Subjects may participate in the study for up to 52 weeks ( in patients still responding after 52 weeks, the drug wil continue to be supplied).


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years at the time of signing the informed consent form
  • MDS with IPSS scores Int-2 or high with deletion 5q(31)
  • Prior thalidomide allowed
  • Documented diagnosis of MDS (RA, RARS, RAEB, RAEB-T and CMML with WBC < 13,000/mm3 according to FAB classification) that meets IPSS criteria for intermediate-2 or high-risk disease and has an associated del 5q[31] (the deleted chromosomal region must include 5q[31]), with or without additional cytogenetic abnormalities

Exclusion Criteria:

  • Pregnant or lactating females
  • Prior therapy with lenalidomide
  • MDS with IPSS scores low or Int-1
  • Clinical neuropathy of greater than grade 2
  • Proliferative (WBC ≥ 13,000/mL) chronic myelomonocytic leukemia (CMML)
  • Recombinant human erythropoietin (rHuEPO) therapy received within 28 days
  • Use of androgens other than for treating hypogonadism
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424229

Contact: .Pierre FENAUX, Professor 0033148955070 pierre.fenaux@avc.aphp.fr
Contact: Fatrima-Zohra HAMZA, CRA 0033148955890 fatima.hamza@aphp.fr

CHU Angers Recruiting
Angers, France, 49033
Contact: Mathilde HUNAULT-BERGER, MD    0033241354475    MHunault@chu-angers.fr   
Principal Investigator: HUNAULT-BERGER, MD         
CHRU Hurriez Recruiting
Lille, France, 59057
Contact: Bruno QUESNEL, Profesor    0033320446640    b-quesnel@chru.fr   
Principal Investigator: QUESNEL, Professor         
Hopital Paoli Calmette Recruiting
Marseille, France, 13273
Contact: Norbert VEY, MD    0033431223695    veyn@marseille.fnclcc.fr   
Principal Investigator: VEY, MD         
Sub-Investigator: CHARBONNIER, MD         
Sub-Investigator: GASTAUT, Professor         
Sub-Investigator: BOUABDALLAH, MD         
Sub-Investigator: REY, MD         
Sub-Investigator: STOPPA, MD         
Hopital Hotel Dieu Recruiting
Nantes, France, 44093
Contact: Jean-Luc HAROUSSEAU    0033240083271      
Principal Investigator: Jacques Delaunay         
Hopital Archet Recruiting
Nice, France, 06202
Contact: Laurence LEGROS    0033492035844    legros.l@chu-nice.fr   
Principal Investigator: LEGROS, MD         
Hoiptal St Louis Recruiting
Paris, France, 75475
Contact: Herve DOMBRET, Profesor    0033142499643    herve.dombret@sls.aphp.fr   
Principal Investigator: Hervé Dombret         
Hopital Cochin Recruiting
Paris, France, 75679
Contact: Francois DREYFUS, Professor    003358412120    francois.dreyfus@cch.aphp.fr   
Principal Investigator: DREYFUS, Professor         
Hopital Jean-Bernard Recruiting
Poitiers, France, 86021
Contact: Francois GUILHOT, Professor    0033549444201    f.guilhot@chu-poitiers.fr   
Principal Investigator: GUILHOT, Profesor         
Sub-Investigator: ROY, MD         
Centre Henry Becquerel Recruiting
Rouen, France, 76 038
Contact: Aspasia Stamatoullas, MD    33 2 32 08 22 88    aspsta@rouen.fnclcc.fr   
Principal Investigator: Aspasia Stamatoullas         
Chu Purpan Recruiting
Toulouse, France, 31059
Contact: Odile BEYNE-RAUZY, Doctor    0033561779679    beynerauzy.o@chu-toulouse.fr   
Principal Investigator: Odile BEYNE-RAUZY         
CHU Brabois Recruiting
Vandoeuvre, France, 54511
Contact: Agnes GUERCI-BRESLER, MD    0033383153281    a.guerci@chu-nancy.fr   
Principal Investigator: GUERCI-BRESLER, MD         
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Study Director: Pierre FENAUX, Profesor Groupe Francophone des Myelodysplasies
Study Director: Sara Burcheri Groupe français des myélodysplasies
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00424229     History of Changes
Other Study ID Numbers: GFM-REV-2006-02
First Submitted: January 15, 2007
First Posted: January 18, 2007
Last Update Posted: March 12, 2007
Last Verified: January 2007

Keywords provided by Groupe Francophone des Myelodysplasies:

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents