Mitchell, M.D., Ph.D. or his designee and to the local IRB per standard reporting proc edures . Fatal or life -threatening, unexpected AEs where there is evidence to suggest a causal relationship between the drug and the adverse event will be reported by the sponsor to the FDA by telephone, facsimile, or in writing as soon as possible, but no later than 7 calendar days after first knowledge by the sponsor followed by as complete a report as possible within 8 additional calendar days. Serious, unexpected AEs that are related or possibly related to the drug but are not fatal or life -threatening will be reported to the FDA by telephone, facsimile, or in writing as soon as possible, but no later than 15 calendar days after first knowledge by the sponsor. Site Investigators will be notified in accordance with 21 CFR 312.32. SAEs that are considered serious, unexpected , and related or possibly related to the research (as defined by 21CRF312.32[a]) will be discussed with the Medical Monitor . At the time of the annual prog ress report to the UF IRB, a summary of the overall toxicity experience will be provided. 17.4.3 ADVERSE EVENT DOCUME NTATION This study will include two adverse event collection periods : non- mobilized leukapheresis and Consolidation or NMA Chemo therapy. The non- mobilized leukapheresis collection period will begin at initiation of leukapheresis Re-MATC H Protocol Page 67 of 106 Version: 20180628 and continue until 24 hours after the completion of the procedure . The Consolidation or NMA Chemotherapy period will be gin at initiation of chemotherapy and continue until 100 days after either the infusion of peripheral blood stem cells or completion of chemotherapy for subjects who did not receive PBSCs . All AEs thought to be related to vaccine therapy (any grade) and all grade 2 or greater AEs will be collected. After t he 100 day reporting period, AEs that are stable and not related to vaccine therapy will not be followed until resolution. If the subject has progression of disease and /or begins another line of therapy or another therapeutic trial the adverse events collection will be discontinued. Events occurring outside the reporting windows that have a possible relationship to vaccine therapy must also be reported. All AEs must be recorded in the subject’s medical record and case report form , if applicable . A su mmary of recorded AEs (not just those considered related to the DC + xALT therapy) will be kept which will categorize the event by organ system, relationship to treatment, its grade of severity, and resolution. The PI will periodically review the collective AEs with the intention of identifying any trends or patterns in toxicity. If any such trends are identified, depending on their severity and frequency, a protocol amendment will be considered. 17.5 Concomitant Medication The following medications will be recorded in the data management system : • Steroids ; • Anticonvulsants ; • Any medication used it the treatment of a VACCINE/STUDY DRUG related AE/SAE ; and • Any medication deemed to possibly be interactive with vaccine or study drug by PI or designee. Start date, stop date, and indication (reporting windows are those of adverse events) will be documented.