Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma
NCT ID: NCT00644306
Last Updated: 2008-03-26
Study Results
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Basic Information
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TERMINATED
PHASE3
232 participants
INTERVENTIONAL
2002-04-30
2007-05-31
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
DOUBLE
Study Groups
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A
12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months
Thalidomide
100 mg/day continuously for 18 months
melphalan, prednisone
12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months
B
12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months
melphalan, prednisone, thalidomide
12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months
Interventions
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Thalidomide
100 mg/day continuously for 18 months
melphalan, prednisone
12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months
melphalan, prednisone, thalidomide
12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Primary or associated amyloïdosis
* World Health organisation performance index of at least 3
* Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more
* Cardiac or hepatic dysfunction
* Cerebral circulatory insufficiency
* Absolute contraindication to corticosteroids
* Peripheral neuropathy clinically significant
* History of venous thrombosis during the last 6 months
* HIV or hepatitis B or C positivity
* Patients who had geography, social, or psychological conditions which might prevent adequate follow-up.
75 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Intergroupe Francophone du Myélome (IFM)
Principal Investigators
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Cyrille Hulin, MD
Role: PRINCIPAL_INVESTIGATOR
Hematology CHU Nancy and Intergroupe Francophone du Myelome (IFM)
Locations
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CHU Nancy - Brabois, rue du morvan
Vandœuvre-lès-Nancy, , France
Countries
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References
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Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, Renaud M, Harousseau JL, Guillerm G, Chaleteix C, Dib M, Voillat L, Maisonneuve H, Troncy J, Dorvaux V, Monconduit M, Martin C, Casassus P, Jaubert J, Jardel H, Doyen C, Kolb B, Anglaret B, Grosbois B, Yakoub-Agha I, Mathiot C, Avet-Loiseau H; Intergroupe Francophone du Myelome. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007 Oct 6;370(9594):1209-18. doi: 10.1016/S0140-6736(07)61537-2.
Other Identifiers
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University Hospital, Nancy
Identifier Type: -
Identifier Source: org_study_id
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