Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
800 participants
INTERVENTIONAL
2000-04-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
No specific intervention
No interventions assigned to this group
2
Biphosphonates
Biphosphonates
Biphosphonates
3
Thalidomide
Thalidomide
Per os thalidomide
Interventions
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Thalidomide
Per os thalidomide
Biphosphonates
Biphosphonates
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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University Hospital Toulouse
Principal Investigators
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ATTAL Michel, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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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
Countries
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References
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Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group. J Clin Oncol. 1998 Dec;16(12):3832-42. doi: 10.1200/JCO.1998.16.12.3832.
Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med. 1996 Jul 11;335(2):91-7. doi: 10.1056/NEJM199607113350204.
Other Identifiers
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PHRC 98-45-N
Identifier Type: -
Identifier Source: org_study_id
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