Cryotherapy as prophylaxis against oral mucositis after high-dose melphalan and autologous stem cell transplantation for myeloma: a randomised, open-label, phase 3, non-inferiority trial

For patients with multiple myeloma receiving high-dose melphalan prior to autologous stem cell transplant, 7-hour prophylactic cryotherapy is the standard of care to prevent oral mucositis. However, results from a randomized, controlled phase 3 trial demonstrated that 2 hours of cryotherapy—administered 30 minutes prior to starting melphalan, 30 minutes during treatment, and for 1 hour after treatment—is as effective as the longer duration, with 2.1% and 4.3% rates of grade 3/4 oral mucositis in the 2-hour and 7-hour cryotherapy arms, respectively.

Bone Marrow Transplantation