69 O - Idarubicin vs mitoxantrone in a continous-infusion cyclophosphamide plus dexamethasone regimen for adyanced refractory myeloma

In the aim of increase the response rate, we replaced VM-26 with idarubicin (IDA) or mitoxanlrone (MITOX) in a salvage regimen consisting of cyclophosphamide (CY) by continous iv infusion plus dexamethasone (DEX), previously reported by us as active in advanced refractory myeloma. 23 pts were randomly assigned to receive monthly courses of 6 mg/mq/d iv IDA (no pts 12) or MITOX (no pts II) on days 1-2, CY 200 mg/mq and DEX 40 mg iv from day I to 7. Eight were primary refractory to MP therapy, 15 were relapsed and refractory to salvage regimens (VAD, YMCP). Median age was 60 yrs (48–70), months from diagnosis 33 (3–140). Four pts were stage II, 19 stage III, 4 had B condition (D & S). 14 were IgG, 7 IgA, 2 BJ. RESULTS: a total of 79 courses were delivered. The response was evaluated after 2–3 courses. Overall, 13 pts (57%) were responders, achieving> 30% reduction of the M component; 7 (30%) were non responders and 3 (13%) died early (2 pulmonary edema, I cerebral hemorrhage). All pts experienced transient leukopenia (median 0.9 WBC), promptly recovered after G-CSF, None had to delay the next course due to leukopenia. Extrahematological toxicity consisted mainly of infections, with gram-positive pneumonia in 4 pts. One pt, although responder, was taken off the study after I cycle for severe arythmia. In conclusion, preliminary results suggest that this regimen is effective and feasible with acceptable toxicity. The study is ongoing, a longer follow-up is required to asses the impact on survival.