Randomized Trial of Cryotherapy Duration Prior to High Dose Melphalan in Myeloma Patients

PRIMARY OBJECTIVES: I. To measure the maximum inpatient mucositis grade after 120- vs. 360-minutes standardized cryotherapy regimens in patients with multiple myeloma undergoing autologous hematopoietic stem cell transplantation at Ohio State Medical Center. SECONDARY OBJECTIVES: I. To develop a pharmacokinetic model predicting variability in unbound serum melphalan area under the concentration-time curve (AUC). II. To compare the neutropenic fever and bacteremia incidence after 120- vs. 360-minute cryotherapy regimens. III. To compare patient-reported mucositis-related symptoms up until discharge utilizing the Patient-Reported Oral Mucositis Symptoms Scale (PROMS) after 120- vs 360-minute cryotherapy regimens. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Beginning fifteen minutes before melphalan treatment, patients receive 1 ounce of shaved ice in their mouth, allow it to melt and then replenish it immediately for 120 minutes. ARM II: Beginning fifteen minutes before melphalan treatment, patients receive 1 ounce of shaved ice in their mouth, allow it to melt and then replenish it immediately for 360 minutes.