Pomalidomide and Dexamethasone Effects in Multiple Myeloma Patients With Del 17p or t (4;14) (IFM2010-02)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by University Hospital, Lille
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01745640
First received: October 29, 2012
Last updated: December 6, 2012
Last verified: September 2011
  Purpose

The purpose of this study is to determine the efficacy and toxicity profile of Pomalidomide and Dexamethasone in relapsed or refractory Multiple Myeloma patients with deletion 17p or translocation (4;14)


Condition Intervention Phase
Multiple Myeloma
Drug: POMALIDOMIDE
Drug: Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Open Label Phase II Study of Pomalidomide and Dexamethasone in Progressive Relapsed or Refractory Multiple Myeloma Patients With Deletion 17p or Translocation (4;14) Adverse Karyotypic Abnormalities-IFM2010-02

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • The primary endpoint is the Time to disease progression (from the date of the first dose to the date of the first observation of disease progression) [ Time Frame: The final analysis of disease progression will be run when at least 29 events will occur (expected average of 32months ). ] [ Designated as safety issue: No ]
    The time to progression (TTP) is the time from the start of treatment to the first documentation of disease progression or death from any cause during study, whichever occurs earlier.The Kaplan-Meier procedures will be used to characterize the time-to-event curves (TTP, OS, response duration and EFS) when there is censoring; univariate summary statistics will be provided for time to response.


Secondary Outcome Measures:
  • To determine Safety of pomalidomide and dexamethasone [ Time Frame: for the first 15 patients included at time they end cycle 1 (an expected average of 6 months from the first inclusion) ] [ Designated as safety issue: Yes ]

    All patients who receive at least one dose of study medication will be included in the safety analyses. Adverse events, vital sign measurements, clinical laboratory information, and concomitant medications will be tabulated and summarized when appropriate.

    Patient incidence rates of all Adverse Events will be tabulated by body system class, preferred term, and severity grades whenever possible and will be provided with the number and percentage of subjects with adverse events


  • To determine Overall Response rate (Partial Response and better), Very Good Partial Response (VGPR) + Complete Response (CR) rate and stringent Complete Response (sCR) rate to pomalidomide and dexamethasone in MM patients [ Time Frame: The final analysis of disease progression will be run when at least 29 events will occur (expected average of 32months from beginning of study ). ] [ Designated as safety issue: No ]
    Response rate (Partial Response and better) to pomalidomide and Dexamethasone in the studied population will be determined using International Myeloma Working Group (IMWG) response criteria. VGPR + CR rate and sCR rate will also be determined using IMWG [1]

  • To determine Time to response and Response duration of pomalidomide and dexamethasone. [ Time Frame: The final analysis of disease progression will be run when at least 29 events will occur (expected average of 32months from beginning of study ). ] [ Designated as safety issue: No ]
    A responder will be any patient who shows at least a partial response (PR) at any time during the study. For responders, time to response and response duration will be analyzed. Time to response is the time from the start of treatment to the first documentation of response (either PR or better). Duration of response is the time from the first PR or better to the first documentation of disease progression. Following the completion of the first cycle, efficacy assessments will be given every 28 days as long as they stay on treatment up to 12 months then every 2 months until progression.

  • Overall Survival of pomalidomide and dexamethasone and event free survival [ Time Frame: The final analysis of disease progression will be run when at least 29 events will occur (expected average of 32months from beginning of study ). ] [ Designated as safety issue: No ]
    The median overall survival for patients with MM is approximately 4-5 years, and MM remains an incurable disease. Overall survival (OS) is the time from the start of treatment to date of last news or death from any cause. Event free survival (EFS) is the time from the start of treatment to the date of progression, death, or other cause of discontinuation of study drug, including serious drug toxicity.

  • To determine Response and Time to disease progression with regards to cytogenetic abnormalities in the bone marrow tumor plasma cells [ Time Frame: The final analysis of disease progression will be run when at least 29 events will occur (expected average of 32months from beginning of study ). ] [ Designated as safety issue: No ]
    Response rate (Partial Response and better) to pomalidomide and Dexamethasone in the studied population will be determined using International Myeloma Working Group (IMWG) response criteria. VGPR + CR rate and sCR rate will also be determined using IMWG [1]


Estimated Enrollment: 55
Study Start Date: January 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: POMALIDOMIDE and dexamethasone treatment
All patients will receive pomalidomide (4 mg/day per os) and dexamethasone (40/20 mg/wk per os) during 21 day/28 day cycle
Drug: POMALIDOMIDE
hard capsule 4mg/day, oral route, from day 1 to 21 per 28 days cycle
Other Name: 4mg/day, oral route, from day 1 to 21 per 28 days cycle
Drug: Dexamethasone
40mg (if patient <75 years)/20mg weekly, oral route, on day 1, 8, 15, 22 per 28 days cycle
Other Name: weekly, oral route, on day 1, 8, 15, 22 per 28 days cycle

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

List of Key inclusion criteria:

  • Must be able to understand and voluntarily sign an informed consent form
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Age >18 years
  • Life expectancy > 6 months.
  • Patients must have a Symptomatic and Progressive MM, as defined by the IMWG Patients must have had lenalidomide therapy as a previous line of therapy as one of the following: Either at front line or at relapse Either as monotherapy or in combination Independent of response obtained with lenalidomide
  • Patients must have a clearly detectable and quantifiable monoclonal M-component value
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • Adequate bone marrow function, with no transfusion within 5 days prior to treatment.
  • Adequate organ function
  • Wash out period of at least 2 weeks from previous antitumor therapy or any investigational treatment.
  • Able to take antithrombotic medicines
  • Subjects affiliated with an appropriate social security system.
  • Agree to abstain from donating blood while taking study drug therapy and for at least 28 days following discontinuation of study drug .
  • Agree never to give the study medication to another person and to return any unused capsules to the investigator at the end of treatment.
  • Female subjects of childbearing potential (FCBP) (*) must:

Understand the potential teratogenic risk of the treatment and take the relative precaution mentioned in the protocol, in the Pomalidomide information sheet Agree to abstain from breastfeeding during study participation and for at least 28 days after study drug discontinuation

  • For female NOT of childbearing potential, pomalidomide is contraindicated unless the exceptions mentioned in the protocol
  • Understand the hazards and necessary precautions associated with the use of pomalidomide
  • Male subjects must:
  • Understand the potential teratogenic risk and take the relative precaution mentioned in the protocol, in the Pomalidomide information sheet .

List of Key Exclusion criteria :

  • Patient that will require allogeneic or autologous transplantation following pomalidomide dexamethasone treatment while in the same course.
  • Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation
  • Pregnant or breast feeding females
  • Use of any other experimental drug or therapy within 15 days of screening.
  • Patients with renal failure that require dialysis and patients with creatinine clearance < 50 mL/min
  • Known positive for HIV or active infectious hepatitis type B or C.
  • Patients with non-secretory MM (non measurable) Prior history of malignancies, other than multiple myeloma, unless the patients has been free of the disease for ≥3 years. Excepted those mentioned in the protocol.
  • Prior local irradiation within two weeks before screening
  • Evidence of central nervous system (CNS) involvement
  • Any >grade 2 toxicity unresolved
  • Peripheral neuropathy > Grade 2
  • Known Hypersensitivity to Thalidomide, Lenalidomide
  • Ongoing active infection, especially ongoing pneumonitis
  • Ongoing Cardiac dysfunction
  • Inability or unwillingness to comply with birth control requirements
  • Unable to take antithrombotic medicines at study entry
  • Unable to take dexamethasone at study entry
  • Refusal to participate in the study Persons protected by a legal regime (guardianship, trusteeship)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745640

Contacts
Contact: Thierry FACON, PHD thierry.facon@chru-lille.fr
Contact: Xavier LELEU, PHD 03.20.44.68.83 xavier.leleu@chru-lille.fr

Locations
France
CHRU - Hôpital du Bocage Not yet recruiting
Angers, Angers cedex 01, France, 49033
Contact: Mamoun DIB, pHD    Tel : 02 41 35 44 72    MaDib@chu-angers.fr   
Principal Investigator: Mamoun DIB, MD         
CHRU-Hôpital Sud Amiens Not yet recruiting
Amiens, France, 80054
Contact: BRUNO ROYER, phD       royer.bruno@chu-amiens.fr   
Principal Investigator: Bruno ROYER, MD         
Centre Hospitalier de la côte basque Not yet recruiting
Bayonne, France, 64109
Contact: ANNE BANOS, DR    Tel : 05.59.44.38.32    abanos@ch-cotebasque.com   
Principal Investigator: Anne BANOS, MD         
Centre Hospitalier BLOIS Not yet recruiting
Blois, France, 41016
Contact: PHILIPPE RODON, DR    02.54.55.64.05    rodonp@ch-blois.fr   
Principal Investigator: Philippe RODON, MD         
Hôpital Avicenne Not yet recruiting
BOBIGNY cedex, France, 93009
Contact: SABINE BRECHIGNAC, DR    01.48.95.56.77    sabine.brechignac@avc.aphp.fr   
Principal Investigator: Sabine BRECHIGNAC, MD         
Chru Caen Recruiting
Caen, France, 14033
Contact: MARGARET MACRO, DR    02.31.27.25.39    macro-m@chu-caen.fr   
Principal Investigator: Margaret MACRO, MD         
CHU DIJON, Hôpital d'Enfants Recruiting
Dijon, France, 21000
Contact: DENIS CAILLOT, DR    03.80.29.33.06    denis.caillot@chu-dijon.fr   
Principal Investigator: Denis CAILLOT, MD         
Hospitalier Général DUNKERQUE Not yet recruiting
Dunkerque, France, 59 385
Contact: MARC WETTERWALD, DR    03 28 28 56 33    marc.wetterwald@ch-dunkerque.fr   
Principal Investigator: Marc WETTERWALD, MD         
CHRU, Hôpital A.Michallon Recruiting
Grenoble, France, 38043
Contact: BRIGITTE PEGOURIE, DR    04.76.76.54.52    bpegourie@chu-grenoble.fr   
Principal Investigator: Brigitte PEGOURIE, MD         
Centre hospitalier départemental La Roche sur Yon Not yet recruiting
La Roche sur Yon, France, 85025
Contact: MOURAD TIAB, DR       mourad.tiab@chd-vendee.fr   
Principal Investigator: Mourad TIAB, MD         
Chru Lille Recruiting
Lille, France, 59037
Contact: XAVIER LELEU, DR    03.20.44.68.83    xavier.leleu@chru-lille.fr   
Principal Investigator: Thierry FACON, PHD         
Institut Paoli Calmette, Recruiting
Marseille, France, 13273
Contact: ANNE MARIE STOPPA, PROF       stoppaam@marseille.fnclcc.fr   
Principal Investigator: Anne Marie STOPPA, MD         
CHRU, Hôtel Dieu Recruiting
Nantes, France, 44035
Contact: PHILIPPE MOREAU, PROF       philippe.moreau@chu-nantes.fr   
Principal Investigator: Philippe MOREAU, MD         
Centre de NICE 2/ Hôpital Archet Not yet recruiting
Nice, France, 06202
Contact: JEAN GABRIEL FUZIBET, PROF       fuzibet.jg@chu-nice.fr   
Principal Investigator: Jean Gabriel FUZIBET, MD         
Centre de NICE 1/ Hôpital Archet Not yet recruiting
Nice, France, 06 202
Contact: LAURENCE LEGROS, DR       legros.l@chu-nice.fr   
Principal Investigator: Laurence LEGROS, MD         
Hôpital Saint-Louis Recruiting
Paris, France, 75475
Contact: BERTRAND ARNULF, DR       bertrand.arnulf@sls.aphp.fr   
Principal Investigator: Bertrand ARNULF, MD         
CHU - Hôpital St Antoine, Recruiting
Paris, France, 75571
Contact: LAURENT GARDERET, DR       laurent.garderet@sat.aphp.fr   
Principal Investigator: Laurent GARDERET, MD         
Hôpital Haut-Leveque Not yet recruiting
PESSAC cedex, France, 33604
Contact: GERALD MARIT, PROF    05.57.65.65.11    gerald.marit@chu-bordeaux.fr   
Principal Investigator: Gerald MARIT, MD         
Centre Hospitalier Lyon Sud -1 Recruiting
Pierre Benite, France, 69495
Contact: LIONNEL KARLIN, DR       lionel.karlin@chu-lyon.fr   
Principal Investigator: Lionnel KARLIN, MD         
Centre Hospitalier Lyon Sud -2 Recruiting
Pierre Benite, France, 69495
Contact: MAURICETTE MICHALLET, PROF       mauricette.michallet@chu-lyon.fr   
Principal Investigator: Mauricette MICHALLET, MD         
CHRU POITIERS-Hôpital Jean Bernard Not yet recruiting
Poitiers, France, 86021
Contact: LAURENCE LACOTTE, DR       l.lacotte@chu-poitiers.fr   
Principal Investigator: Laurence LACOTTE, MD         
Hôpital Robert Debré, CHU Reims Not yet recruiting
Reims, France, 51092
Contact: BRIGITTE KOLB, DR       bkolb@chu-reims.fr   
Principal Investigator: Brigitte KOLB, MD         
CHRU RENNES 2, Hôpital Pontchaillou Recruiting
Rennes, France, 35033
Contact: MARTINE ESCOFFRE BARBE, PROF       martine.escoffre-barbe@chu-rennes.fr   
Principal Investigator: Martine ESCOFFRE BARBE, MD         
CHRU RENNES 1, Hôpital Sud Not yet recruiting
Rennes, France, 35056
Contact: OLIVIER DECAUX, DR       Olivier.Decaux@chu-rennes.fr   
Principal Investigator: Olivier DECAUX, MD         
CHRU, Hôpital Purpan Not yet recruiting
Toulouse, France, 31059
Contact: MICHEL ATTAL, PROF       attal.m@chu-toulouse.fr   
Principal Investigator: Michel ATTAL, MD         
CHRU- Hôpital Bretonneau Not yet recruiting
Tours, France, 37044
Contact: LOFTI BENBOUBKER, DR       l.benboubker@chu-tours.fr   
Principal Investigator: Lotfi BENBOUBKER, MD         
CHRU, Hôpitaux de Brabois Recruiting
Vandoeuvre, France, 54511
Contact: CYRILLE HULIN, DR       c.hulin@chu-nancy.fr   
Principal Investigator: Cyrille HULIN, MD         
Sponsors and Collaborators
University Hospital, Lille
Celgene Corporation
Investigators
Principal Investigator: Xavier LELEU, PHD CHRU de Lille
  More Information

No publications provided

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01745640     History of Changes
Other Study ID Numbers: 2010_52, 2011-002081-20
Study First Received: October 29, 2012
Last Updated: December 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United States: Food and Drug Administration

Keywords provided by University Hospital, Lille:
Multiple myeloma
dexamethasone
pomalidomide
response
safety
del 17p
t 4-14

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Pomalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on August 20, 2014