ARST2031: Randomized Phase 3 Trial of VINO-AC Plus VINO-CPO Maintenance vs VAC plus VINO-CPO Maintenance for HR RMS)

This study will employ a VAC backbone with an intermediate cyclophosphamide dose to minimize toxicity while evaluating the addition of (1) vinorelbine to the VAC backbone and (2) maintenance therapy. Vinorelbine has demonstrated clinical activity in RMS patients who have relapsed or not responded to treatment and has also been shown to provide a survival benefit when given as maintenance chemotherapy along with oral cyclophosphamide for a select group of patients who have achieved a complete remission. The overall goals of this study are: • To find out if vinorelbine can be given safely in combination with VAC, • To compare the effects, good and/or bad, vinorelbine has on people with HR-RMS, and • To find out if adding maintenance therapy will help get rid of the cancer and/or lower the chance that the cancer comes back.