MM-574 Safety of a Cannabis-Based Oil for Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation: Protocol of a Phase I/II Study

• Published in: Clinical lymphoma, myeloma and leukemia Vol. 24; pp. S573 - S574
• Main Authors: Américo, André Dias, Matos Pessoa, Juliana, Silva Pimentel Pittol, Isabella, Cordeiro, Camilla, Da Silva, Gilmara Silveira, Colosimo, Flávia, Moreno Gusmão, Breno
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.09.2024
• Subjects: autologous stem cell transplantation; cannabidiol; multiple myeloma; quality of life; symptoms; MM; cannabidiol; symptoms; multiple myeloma; quality of life; autologous stem cell transplantation
• ISSN: 2152-2650
• DOI: 10.1016/S2152-2650(24)01710-5

Autologous stem cell transplantation (ASCT) is associated with symptoms that impact quality of life of patients living with multiple myeloma (MM). Cannabis products are used to mitigate adverse events related to cancer, yet safety data regarding its use among patients receiving highintensity chemotherapy are not available. Currently under Brazilian regulation, cannabis-based products are allowed to be commercialized as long as THC concentrations do not exceed 0.2%. Establish the safety and maximal tolerated dose of cannabidiol for patients with MM undergoing ASCT. Access the capacity of a cannabis-based product to reduce the burden of symptoms related to the administration of myeloablative chemotherapy. Adult patients with MM, candidates for ASCT. Allergy to any component of the intervention, incapacity to fill the study's surveys, use of valproate or clobazam, prior episode of mania, prior admission to a psychiatric ward, current use of antipsychotic medication, and history of substance abuse for the last 5 years. This is a phase I/II clinical trial of Cannabis stratum 160.3 mg/mL (CBD 90 mg/mL, THC 2.3 mg/mL). During phase I, we will follow a 3+3 design to access the maximal dose. The target dose for each cohort will be 50 mg for cohort A, 100 mg for cohort B, 200 mg for cohort C, and 300 mg for cohort D. The stratum will begin 7 days prior to ASCT admission and conclude 15 days after hospital discharge. At phase II, the maximum tolerated dose will be administered to 15 patients to gauge the treatment efficacy. The study will enroll ≤39 patients. Dose-limiting toxicities (hepatotoxicity, psychotropic effects or “high,” hallucinations or delirium, psychosis and paranoia, agitation, major depressive episode, mania or hypomania, incapacity to reach target dose). Quality of life (accessed with EORTC QLQ-30 and EORTC MY-20), body weight and albumin levels, dietary intake (by a dietitian), highest-grade mucositis, requirement of antiemetics, requirement of painkillers, hospital discharge, neutrophilic and platelet engraftment, admissions to the ICU, febrile neutropenia, and infections. The study will start accruing patients in June 2024.