Reason for request

Re-assessment of the actual benefit

Moderate improvement of actual clinical benefit in patients with previously untreated multiple myeloma, eligible or not for a haematopoietic stem cell transplant

 

  • In the treatment of previously untreated multiple myeloma, VELCADE is a standard treatment, in patients:

      - eligible for intensive chemotherapy, accompanied by a haematopoietic stem cell transplant in induction treatment, in combination with dexamethasone and thalidomide (VTD regimen).

      - not eligible for intensive chemotherapy, accompanied by a haematopoietic stem cell transplant, in combination with melphalan and prednisone (MPV regimen).

  • Given the lack of comparative data between VELCADE in combination with the products mentioned above and other current standard treatments, in particular MPT (Melphalan/Prednisone/Thalidomide) and more recently the combination of REVLIMID (lenalidomide) with dexamethasone until progression in patients not eligible for transplant and not previously treated, the place of thalidomide and lenalidomide compared to VELCADE is not established.

Clinical Benefit

Substantial

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Clinical Added Value

moderate

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Therapeutic use

-

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