A PHASE I II TRIAL OF Z-DEX (ORAL IDARUBICIN AND DEXAMETHASONE), AN ORAL EQUIVALENT OF VAD, AS INITIAL THERAPY AT DIAGNOSIS OR PROGRESSION IN MULTIPLE-MYELOMA/

We designed an oral equivalent regime to mimic VAD and its hybrids, us ing idarubicin and dexamethasone (Z-Dex) given in four cycles to induc e cytoreduction prior to dose intensification in multiple myeloma case s. 20 patients (de novo n=15, replaced VAD n=2, relapsed n=2, and resi stant n=1), 13 males and seven females with a median age of 54 years ( range 40-65 years) received Z-Dex therapy. The overall response rate w as 70% (14/20), with one patient (5%) achieving complete remission (CR ). The response rate for previously untreated patients was 80% (12/15) , with a CR rate of 6 . 7% (1/15). Both patients who received Z-Dex in place of VAD continued to respond. Myelosuppression was seen in 14/20 patients (70%); 4/20 (20%) developing severe neutropenia with one dea th from neutropenic sepsis. Gastrointestinal toxicity and alopecia wer e infrequently reported. Satisfactory responses can be obtained using an oral regime equivalent to VAD with tolerable toxicity and morbidity .