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A Phase 2, Multicentre, Randomised, Open-Label, Parallel Group Study to Evaluate the Safety and Efficacy of VELCADE® in combination with Dexamethasone or VELCADE® in combination with Dexamethasone and...

Update Il y a 4 ans
Reference: EUCTR2007-001462-33

A Phase 2, Multicentre, Randomised, Open-Label, Parallel Group Study to Evaluate the Safety and Efficacy of VELCADE® in combination with Dexamethasone or VELCADE® in combination with Dexamethasone and Cyclophosphamide or VELCADE® in combination with Dexamethasone and Lenalidomide in Subjects with Multiple Myeloma who are Refractory to or Have Relapsed / progressed after Primary Therapy for Multiple Myeloma and have achieved stable disease after 4 cycles of VELCADE®/Dexamethasone therapy

Woman and Man

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Extract

The primary objective is to assess the efficacy of adding either Cyclophosphamide or Lenalidomide to the combination of Velcade® (bortezomib) and Dexamethasone in subjects with multiple myeloma who are refractory to or have relapsed/progressed after their primary therapy for multiple myeloma and once enrolled in this study have achieved a stable disease response after four cycles of Velcade® and Dexamethasone. The efficacy response will be measured by the response rate of the disease.

Inclusion criteria

  • Multiple myeloma

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