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, using idarubicin and dexamethasone (Z-Dex) given in four cycles to induce cytoreduction prior to dose intensification in multiple myeloma cases. 20 patients (de novon=15, replaced VAD n=2, relapsed n=2, and resistant 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 was 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 death from neutropenic sepsis. Gastrointestinal toxicity and alopecia were infrequently reported. Satisfactory responses can be obtained using an oral regime equivalent to VAD with tolerable toxicity and morbidity.