A Phase II Study of Bendamustine, Velcade and Dexamethasone (BVD) in the Treatment of Elderly Patients (>= 65 Years) With Multiple Myeloma in 1st Relapse or Refractory to 1st Line Therapy
After relapse or after early progression on first-line treatment, the prognosis of multiple
myeloma (MM) patients is unfavourable, and the search for new treatment regimens, including
drugs with novel mechanisms of action is essential.
Bendamustine and bortezomib have shown high activity boch in first-line regimens and
pre-treated patients. The novel mechanism of action of the proteasome inhibitor and the
non-cross resistance of bendamustine to other alkylating agents established in the
first-line treatment of multiple myeloma seem to recommend a combination of the two drugs
for salvage therapy (second-line regimen). Finally, the promising response data in a series
of relapsing MM patients treated with bendamustine, bortezomib and prednisone support this
assumption, as well as the feasibility and tolerability of the combination.
In summary, there is some evidence for a favorable risk/benefit ratio for the combination of
bendamustine, bortezomib and a corticoid drug, warranting the exploration in a larger,
prospectively designed multicenter phase II study.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess of the overall response rate (complete response (CR) + partial response (PR))
After four 28-day consecutives cycles
Philippe RODON, Doctor
Unité Hématologie Biologique Institut Curie PARIS
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)