Several centers are exploring the use of Velcade in the peri-transplant setting, including use as part of a the conditioning regimen prior to
autologous stem cell transplant, as well as for relapse following
allogeneic stem cell transplant.
Clinicians at the University of Arkansas are evaluating the addition of Velcade to high-dose melphalan as a conditioning regimen for autologous stem cell transplant. (Hollmig et al.
Blood. 2004;104(11). Abstract 929.) Preliminary efficacy results on 29 of 37 heavily pretreated patients suggest that Velcade can be safely added to melphalan (up to 250 mg/m² administered as fractionated dosing) with a high response rate (73% CR + PR) in this population. Non-hematologic Grade 3/4 toxicities included mucositis (14%), diarrhea (29), infection (56%), and fatigue (59%). Hospitalization was required in 28% of patients but no fatal complications were seen.
Clinicians at M.D. Anderson are also retrospectively evaluating Velcade as treatment for 9 patients with relapsed disease following allogeneic stem cell transplant. (Giralt et al.
Blood. 2004. 104(11). Abstract 1651.) Six patients responded to Velcade therapy with a PR or better. The drug was well tolerated and no flare-ups of
graft-versus-host disease (GVHD) was noted. Two Phase II studies of Velcade use following allogeneic transplant are ongoing.