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IFM 99-02 Thalidomide in Myeloma

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.
 
ClinicalTrials.gov Identifier: NCT00222053
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 2, 2010
Sponsor:
Information provided by:
University Hospital, Toulouse

Brief Summary:
Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Thalidomide Drug: Biphosphonates Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2000
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Thalidomide

Arm Intervention/treatment
No Intervention: 1
No specific intervention
Active Comparator: 2
Biphosphonates
Drug: Biphosphonates
Biphosphonates

Experimental: 3
Thalidomide
Drug: Thalidomide
Per os thalidomide




Primary Outcome Measures :
  1. Duration of response [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: 3 years ]
  2. Toxicity [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • de novo myeloma
  • according to Durie and Salmon classification stage II, III and stage I with a lytic bone lesion
  • patients from 18 to 65 years old
  • beta2microglobulin < 3 mg/l or del13 absent
  • signed informed consent
  • eligible for transplantation

Exclusion Criteria:

  • peripheral neurological toxicities
  • uncontrolled or severe cardiovascular disease
  • other malignancy except basocellular carcinoma or FIGO stage I carcinoma of the cervix
  • patient who received biphosphonate during the last 60 days
  • renal failure definited as creatinine > 150 µmol/l
  • patient with obvious vascular cerebral medical history
  • liver dysfunction definited as bilirubin > 35 µmol/l or ASAT, ALAT, PAL > 4N
  • respiratory dysfunction
  • HIV +
  • Patient who refused to use an acceptable barrier method for contraception

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): NCT00222053


Locations
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France
Médecine Interne, CHU Purpan
Toulouse, France
Médecine Interne, Hôpital Rangueil
Toulouse, France
Rhumatologie, CHU Purpan
Toulouse, France
Rhumatologie, CHU Rangueil
Toulouse, France
Service d'hématologie, CHU Purpan
Toulouse, France
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: ATTAL Michel, MD CHU Toulouse
Publications:
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Responsible Party: LLAU ME, University Hospital Toulouse
ClinicalTrials.gov Identifier: NCT00222053    
Other Study ID Numbers: PHRC 98-45-N
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: April 2, 2010
Last Verified: April 2010
Keywords provided by University Hospital, Toulouse:
Myeloma
Autologous transplantation
Maintenance therapy
Thalidomide
Additional relevant MeSH terms:
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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
Thalidomide
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
Antineoplastic Agents