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Lenalidomide in Subject With Low and Intermediate-1 Risk MDS and Without Chromosome 5 Abnormality.

This study is currently recruiting participants.
Verified October 2012 by Groupe Francophone des Myelodysplasies
Sponsor:
Collaborators:
Celgene Corporation
Roche Pharma AG
Information provided by (Responsible Party):
Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier:
NCT01718379
First received: October 23, 2012
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

The goal of the present study is to assess, through a randomized phase II trial, the efficacy and safety of Lenalidomide with or without Epoetin beta in transfusion-dependent, ESA-resistant, IPSS low and intermediate-1 risk MDS patients without chromosome 5 abnormality.

Patients will receive either Lenalidomide alone or Lenalidomide and Epoetin beta for 4 months. Responders will be eligible for maintenance treatment with cycles identical to the first cycles, until relapse occurs or until unacceptable toxicity.


Condition Intervention Phase
Myelodysplastic Syndromes
 Drug: Lenalidomide
Drug: Epoetin beta
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Evaluating the Efficacy/Safety of Lenalidomide With or Without Epoetin Beta in Transfusion-dependent ESA-resistant Patients With IPSS Low- and Intermediate-1 Risk Myelodysplastic Syndromes Without Chromosome 5 Abnormality.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Groupe Francophone des Myelodysplasies:

Primary Outcome Measures:
  • Comparing the efficacy of Lenalidomide alone to Lenalidomide with Epoetin beta in transfusion-dependent ESA-resistant [ Time Frame: After 4 months of treatment ] [ Designated as safety issue: Yes ]

    Primary outcome is a complete or partial response defined by the IWG 2006 criteria observed after 4 months of treatment. Comparison in the rate of response between the two groups will be performed with Chi-square test or if necessary Fisher exact test.

    Same analyzes will be performed with the IWG 2000 response definition .



Secondary Outcome Measures:
  • will be to assess the safety of Lenalidomide and of its combination with Epoetin beta [ Time Frame: After 2 months of treatment ] [ Designated as safety issue: Yes ]
    • Safety of Lenalidomide and of its combination with Epoetin beta: adverse events (type, frequency, severity) and relationship of adverse events to study drug
    • % of major HI-E and minor HI-E after 4 courses according to IWG 2000 criteria
    • Erythroid response duration
    • Time to response
    • Time to progression according to IPSS
    • RBC transfusion independence
    • Prognostic factors of response
    • Survival
    • Quality of life


Estimated Enrollment: 132
Study Start Date: July 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A

Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses.

Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria.

Maintenance: responders will continue to follow the corresponding treatment arm until relapse occurs; non responders at cycle 4 in arm A will be considered in failure of treatment and the introduction of Epoetin beta is at the discretion of the physician.

The patients will be followed every 3 months for 12 months

 Drug: Lenalidomide
Lenalidomide:10 mg per day during 21 days
Other Name: Revlimid
Experimental: Arm B

Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses combined with weekly subcutaneous injections of Epoetin beta (60,000 Units/w).

Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria.

Maintenance: responders will continue to follow the corresponding treatment arm until relapse occurs; non responders at cycle 4 in arm A will be considered in failure of treatment and the introduction of Epoetin beta is at the discretion of the physician.

The patients will be followed every 3 months for 12 months

 Drug: Epoetin beta
Epoetin beta: 60,000 Units/week.
Other Name: NEORECORMON

Detailed Description:

This is a multi-center, open-label, randomized, Phase II study.

Patients will be treated either with arm A or B

  • Arm A: Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses.
  • Arm B: Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses combined with weekly subcutaneous injections of Epoetin beta (60,000 Units/w).

Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria.

Maintenance: responders will continue to follow the corresponding treatment arm until relapse occurs; non responders at Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria.

in arm A will be considered in failure of treatment and the introduction of Epoetin beta is at the discretion of the physician.

The patients will be followed every 3 months for 12 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

MDS defined as

  • Low or int-1 IPSS score
  • Documented absence of chromosome 5 abnormality (del(5q) or -5 karyotype)
  • De novo MDS, excluding therapy-related MDS AND
  • Transfusion dependance (requirement of at least 4 units of RBC transfusions every 8 weeks )
  • Resistance or loss of response to a previous treatment with Epoetin alpha/beta (at least 60,000 Units/w) or Darbepoetin (at least 250 µg/w), for at least 12 weeks
  • Ineligibility for allogeneic stem cell transplantation or intensive chemotherapy during the next 12 months
  • ECOG performance status ≤ 2
  • Age ≥ 18 years
  • Life expectancy ≥ 3 months
  • Adequate liver function (transaminases serum levels ≤ 3N)
  • Adequate renal function (calculate creatinine clearance > 50 ml/min)
  • Female subjects of chilbearing potential* must :

Agree to use effective contraception without interruption throughout the study and for at least 4 weeks after the end of treatment

• Men must: Agree to not conceive during the treatment and to use effective contraception during the treatment period (including periods of dose reduction or temporary suspension) and during one week after end of treatment if their partner is of childbearing potential.

Exclusion Criteria:

  • Active serious infection not controlled by oral or intravenous antibiotics
  • Platelets less than 50 G/L
  • Prior history of deep vein thrombosis or pulmonary embolism
  • Previous treatment by Thalidomide
  • Treatment with any investigational antileukemic agent or chemotherapy at least 6 weeks prior to study entry and lack of full recovery from side effects due to prior therapy independent of when that therapy were given
  • Rapidely progressive disease with copromised organ function judged to be life-threatening by the Investigator
  • Pregnant or lactating female
  • Known human immunodeficiency virus (HIV) infection
  • Known active hepatitis B and/or C virus infection
  • Hypersensitivity or intolerance to Lenalidomide or any of the excipients
  • Hypersensitivity to Epoetin beta or any of the excipients
  • Uncontrolled arterial hypertension
  • Any history of malignancy (other than myelodysplastic syndrome) unless the patient has remained disease free for more than 5 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718379

Contacts
Contact: Andréa TOMA, MD 01 49 81 20 53 andrea.toma@hmn.aphp.fr
Contact: François DREYFUS, MD 01 42 34 87 65 francois.dreyfus@cch.aphp.fr

Locations
France
Hematology Dpt, Service d'Hématologie Clinique Recruiting
CHU Albert Michallon, Grenoble, France, 38043
Contact: Stéphane COURBY, MD     04 76 76 12     SCourby@chu-grenoble.fr    
Principal Investigator: Stéphane COURBY, MD            
Hematology Dpt, CHU de Bicêtre Recruiting
Le Kremlin-Bicêtre, Ile de France, France, 94275
Contact: Gérard Tertian, MD     01 45 21 35 93     gerard.tertian@bct.aphp.fr    
Principal Investigator: Gérard TERTIAN, MD            
Hematology Dpt, CHU Cochin Recruiting
Paris, Ile de France, France, 75679
Contact: Francois Dreyfus, MD,PhD     00331 58 41 21 20     francois.dreyfus@cch.aphp.fr    
Principal Investigator: François DREYFUS, PhD            
Hematology Dpt, CHU AMIENS Recruiting
Amiens, France, 80054
Contact: GHANDI DAMAJ, MD     +33 322455915     damaj.gandhi@chu-amiens.fr    
Hematology Dpt, CHU Angers Recruiting
Angers, France, 43033
Contact: Mathilde HUNAULT-BERGER, Doctors     0033241354475     MaHunault@chu-angers.fr    
Hematology Dpt, CH d'Avignon-305 rue Follereau- Recruiting
Avignon, France, 84000
Contact: Borhane SLAMA, MD     0033432753132     bslama@ch-avignon.fr    
Principal Investigator: SLAMA, MD            
Hematology Dpt, CH de la Cote Basque Recruiting
Bayonne, France, 64 100
Contact: Frederic Bauduer, MD     33 5 59 44 38 33     fbauduer001@chicb.com    
Hematology Dpt, Hopital Avicenne Recruiting
Bobigny, France, 93009
Contact: Pierre Fenaux, MD,PhD     01 48 95 70 50     pierre.fenaux@avc.aphp.fr    
Sub-Investigator: Pierre FENAUX, Profesor            
Hematology Dpt, CHU Haut-Lévèque Recruiting
Bordeaux, France, 33604
Contact: Krimo BOUABDALLAH, MD     +33 5-57-65-65-11     krimo.bouabdallah@chu-bordeaux.fr    
Principal Investigator: Krimo Bouabdallah, MD            
Hôpital Boulogne Sur Mer Recruiting
Boulogne Sur Mer, France, 62321
Contact: Bachra Chouffi, Dr     +33 3 21 99 82 02     b.chouffi@ch-boulogne.fr    
Principal Investigator: Bachra Chouffi, MD            
Hematology Dpt, CHU Clémenceau Recruiting
Caen, France, 14033
Contact: Stéphane Cheze, MD     +33 231272360     cheze-s@chu-caen.fr    
Hematology Dpt, CH René Dubos Recruiting
Cergy-pontoise, France, 95303
Contact: Riad Benramdane, MD         benramdaner@yahoo.fr    
Contact: Magalie Amirault         magalie.amirault@ch-pontoise.fr    
Principal Investigator: Riad Benramdane, MD            
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63058
Contact: Benoit De RENZIS, MD     04 73 75 00 65     bderenzis@chu-clermontferrand.fr    
Principal Investigator: Benoit De RENZIS, MD            
Hematology Dpt, Hôpital Sud Francilien Recruiting
Corbeil-essonnes, France, 91100
Contact: Célia SALANOUBAT, MD     00 33 1 60 90 37 78     celia.salanoubat@ch-sud-francilien.fr    
Principal Investigator: Celia SALANOUBAT, MD            
Hematology Dpt, Henri Mondor Recruiting
Créteil, France, 94010
Contact: Andréa TOMA, MD     01 49 81 20 53     andrea.toma@hmn.aphp.fr    
Hematology Dpt, CHU de Dijon Recruiting
Dijon, France, 21034
Contact: Denis CAILLOT     0033380293645     denis.caillot@chu-dijon.fr    
Sub-Investigator: BERGER, MD            
Sub-Investigator: BASTIE, MD            
Sub-Investigator: CASANOVAS, MD            
Sub-Investigator: SOLARY, Professor            
Hematology Dpt, Hôpital Versailles Recruiting
Le Chesnay, France, 78157
Contact: Sylvie Castaigne, Pr     01 39 63 82 96     scastaigne@chu-versailles.fr    
Principal Investigator: Anne-Laure TAKSIN, DR            
Hematology Dpt,CH Le mans Recruiting
Le mans, France, 72037
Contact: Kamel Laribi, MD     0243421060     klaribi@]ch-lemans.fr    
Principal Investigator: Kamel Laribi, MD            
Hematology Dpt, Hopital Saint-Vincent de Paul Recruiting
Lille, France, 59160
Contact: Christian Rose, Professor     +33 20874532     rose.christian@ghicl.net    
Hematology Dpt, Centre Hospitalier Lyon Sud Recruiting
Lyon, France, 69495
Contact: Eric WATTEL, PHD,MD     04 72 11 74 01     wattel@lyon.fnclcc.fr    
Principal Investigator: Eric WATTEL, PHD,MD            
Hematology Dpt, Institut Paoli Calmettes Recruiting
Marseille, France, 13009
Contact: Norbert VEY, PHD,MD     04 91 22 37 54     veyn@marseille.fnclcc.fr    
Principal Investigator: Norbert VEY, PHD,MD            
Hematology Dpt, CHU Brabois Recruiting
Nancy, France, 54511
Contact: Agnes Guerci, MD     +33 383153281     a.guerci@chu-nancy.fr    
Principal Investigator: Agnes Guerci, MD            
Hematology Dpt, CHU de nantes Recruiting
Nantes, France, 44093
Contact: Jean-Luc HAROUSSEAU, MD,PhD     02 40 08 32 71     jeanluc.harousseau@chu-nantes.fr    
Principal Investigator: Jacques Delaunay, MD            
Hematology Dpt, CHU Archet Recruiting
Nice, France, 06202
Contact: Laurence LEGROS, DOCTOR     00 33 4 92 03 58 44     legros@nice.fr    
Principal Investigator: Laurence LEGROS, MD            
Hematology Dpt, CHU Caremeau Recruiting
Nimes, France, 30029
Contact: Eric Jourdan, MD     04 66 68 32 31     jourdan@chu-nimes.fr    
Hematology Dpt, CHR La Source orléans Recruiting
Orléans, France, 45067
Contact: Michèle Schoenwald, MD     02 38 22 95 52     michele.schoenwald@chr-orleans.fr    
Principal Investigator: Michèle Schoenwald, MD            
Hematology Dpt, Hopital Saint Louis Recruiting
Paris, France, 75475
Contact: Herve DOMBRET, MD PhD     00 33 1 42 49 96 43     herve.dombret@sls.aphp.fr    
Principal Investigator: Herve DOMBRET, MD PhD            
Sub-Investigator: Emmanuel Raffoux, MD            
Hematology Dpt, Hôpital la pitié-Salpétrière Recruiting
Paris, France, 75013
Contact: Karim MALOUM, MD     01 42 16 24 52     karim.maloum@psl.aphp.fr    
Principal Investigator: Karim MAloum, MD            
Hematology Dpt, Hopital Saint Antoine Recruiting
Paris, France, 75571
Contact: Francoise ISNARD, MD     00033149282622     francoise.isnard@sat.aphp.fr    
Hematology Dpt, Hôpital Maréchal Joffre Recruiting
Perpignan, France, 66046
Contact: Laurence SANHES, MD     +33 4 68 61 64 48     laurence.sanhes@ch-perpignan.fr    
Contact: Gaelle Clavère     +33 4 68 61 89 02     gaelle.clavere@ch-perpignan.fr    
Principal Investigator: Laurence Sanhes, MD            
Hematology Dpt, Hôpital Jean Bernard Recruiting
Poitiers Cedex, France, 86021
Contact: Lydia Roy, MD     +33 444307549     l.roy@chu-poitier.fr    
Hematology Dpt, Centre Hospitalier de la région d'Annecy Recruiting
Pringy cedex, France, 74374
Contact: Pascale Cony-Makhoul, MD     +33 450636369     pconymakhoul@ch-annecy.fr    
Principal Investigator: Pascale CONY-MAKHOUL, MD            
Hematology Dpt, CHRU de Reims Recruiting
Reims, France, 51092
Contact: Chantal HIMBERLIN, MD     003326783644     chimberlin@chu-reims.fr    
Principal Investigator: HIMBERLIN, MD            
Hematology Dpt, Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: Aspasia Stamatoulas, MD     +33 232082288     astamatoulas@rouen.fnclcc.fr    
Hematology Dpt, CHU STRASBOURG Recruiting
Strasbourg, France, 67098
Contact: Shanti NATARAJAN-AME, MD     00 33 3 88 12 76 70     shanti.ame@chru-strasbourg.fr    
Principal Investigator: Shanti NATARAJAN-AME, MD            
Hematology Dpt, CHU PURPAN Recruiting
Toulouse, France, 31059
Contact: Odile BEYNE-RAUZY, Doctor     0033561779679     beynerauzy.o@chu-toulouse.fr    
Principal Investigator: Odile BEYNE-RAUZY            
Hematology Dpt, CH CHU Bretoneau Recruiting
Tours, France, 37044
Contact: Emmanuel Gyan, MD     +33 2 47 47 47 47     e.gyan@chu-tours.fr    
Sub-Investigator: Caroline DARTIGEAS, Doctor            
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Celgene Corporation
Roche Pharma AG
Investigators
Principal Investigator: Andréa TOMA, MD Groupe Francophone des Myelodysplasies
Study Director: François Dreyfus, MD Groupe Francophone des Myelodysplasies
  More Information

No publications provided

Responsible Party: Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier: NCT01718379     History of Changes
Other Study ID Numbers: GFM-Len-Epo-08
Study First Received: October 23, 2012
Last Updated: October 29, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Francophone des Myelodysplasies:
Myelodysplasia

Additional relevant MeSH terms:
Congenital Abnormalities
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Epoetin Alfa
Lenalidomide
Thalidomide
Hematinics
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013