This phase II trial studies how well netupitant and palonosetron hydrochloride work in preventing chemotherapy induced nausea and vomiting in patients with cancer undergoing BEAM conditioning regimen before stem cell transplant. Chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan (BEAM), makes people feel sick to their stomach and causes vomiting. Netupitant and palonosetron hydrochloride may reduce the nausea and vomiting caused by the BEAM treatment.
PRIMARY OBJECTIVES: I. To assess the efficacy of netupitant and palonosetron hydrochloride (NEPA) to prevent nausea and vomiting both during and after a highly emetogenic (BEAM) conditioning regimen for hematopoietic stem cell transplantation (HSCT). SECONDARY OBJECTIVES: I. To differentiate response to NEPA over different phases of chemotherapy-induced nausea. OUTLINE: Within 60 minutes before standard of care BEAM treatment, patients receive netupitant and palonosetron hydrochloride orally (PO) on days 1, 3, and 6. After completion of study treatment, patients are followed up at 14 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
43
300 mg, Given PO, QD
0.5 mg, Given PO, QD
Ancillary studies
OHSU Knight Cancer Institute
Portland, Oregon, United States
Complete Response (CR) Defined as no Emesis and no Rescue Therapy
Number of subjects that reached a complete response (CR), defined as having no emesis and no rescue therapy.
Time frame: Up to 5 days post chemotherapy
CR (Acute Phase)
Number of subjects that reached a complete response (CR), defined as having no emesis and no rescue therapy from 0 to 144 hours (acute phase) of the study drug administration.
Time frame: Up to 144 hours post-study drug administration on day 1
CR (Delayed Phase)
Number of subjects that reached a complete response (CR), defined as having no emesis and no rescue therapy from 145 hours up to 264 hours (delayed phase) of the study drug administration.
Time frame: From 145 hours up to 264 hours post-study drug administration on day 1
Complete Protection (CP) Rate Defined as CR Plus no Nausea
Number of subjects that reached a complete response (CR), defined as having no emesis and no rescue therapy from 0 to 264 hours of the study drug administration.
Time frame: Up to 264 hours post-study drug administration on day 1
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