A Phase 2, Multicentre, Randomised, Open-Label, Parallel Group Study to Evaluate the Safety and Efficacy of Velcade® when added to Adriamycin-Dexamethasone Treatment versus Vincristine-Adriamycin-Dexa...

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Reference: EUCTR2006-001709-27

A Phase 2, Multicentre, Randomised, Open-Label, Parallel Group Study to Evaluate the Safety and Efficacy of Velcade® when added to Adriamycin-Dexamethasone Treatment versus Vincristine-Adriamycin-Dexamethasone Standard Treatment in Subjects with Multiple Myeloma who are Refractory to or Have Relapsed after Primary Therapy for Multiple Myeloma

Woman and Man

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Extract

To assess the safety and efficacy of replacing vincristine with Velcade® (bortezomib, also named PS341) in the standard therapy vincristine, adriamycin and dexamethasone (VAD) in subjects with multiple myeloma who are refractory to or have relapsed after their primary therapy for multiple myeloma. The efficacy response will be measured by the response rate of the disease.


Inclusion criteria

  • Multiple myeloma