Acute lymphoblastic leukaemia-type intensive chemotherapy to eliminate minimal residual disease after high-dose melphalan and autologous transplantation in multiple myeloma - a phase I/II feasibility and tolerance study of 17 patients

Aiming to target the minimal residual disease in patients with multiple mye loma, a phase I/II single centre study was undertaken for feasibility and t olerance of intensive acute lymphoblastic leukaemia consolidation chemother apy (ALL-IC) as part of a strategy for post-transplant consolidation target ed at pre-B cells. Seventeen newly diagnosed patients with myeloma (median age 55 years; 30-65) were initially treated with courses of infused cycloph osphamide, vincristine, adriamycin and methylprednisolone (C-VAMP) followed by melphalan 200 mg/m(2) (HDM) and peripheral blood stem cell rescue (PBSC ). Forty-seven percent were in CR and the rest in PR after HDM. ALL-IC cons isted of vincristine, daunorubicin, etoposide, cytarabine, 6-thioguanine an d prednisolone given over 5 days. All patients became neutropenic (<0.5 x 1 0(9)/l) at a median of 10 days (4-18) and one of the 17 patients (5.8%) die d 15 days post ALL-IC of sepsis. A further four have died of relapse with a n overall survival (OS) of 67% at 4 years. Two of nine patients in PR at th e time of ALL-IC achieved CR. Matched-pair analysis of 34 control patients shows no difference for OS and event-free survival between ALL-IC and contr ols. We conclude that ALL-IC given to myeloma patients after HDM/PBSC is as safe as when used in ALL and warrants further assessment in randomised tri als for myeloma.