ALBERT

Description: Background Ixazomib, the first oral proteasome inhibitor, has been approved for 〉3 years in 〉70 countries, for the treatment of RRMM pts who have received ≥1 prior therapy, on the basis of the TOURMALINE-MM1 study, which reported an overall response rate (ORR) of 78% and median progression free survival (PFS) of 20.6 mos. Although outcomes and tolerability in routine clinical practice often differ from data reported in clinical trials, growing evidence suggest that outcomes in patients treated with ixazomib-based regimens are comparable to those in the Phase 3 TOURMALINE-MM1 trial. We report on an expanded pooled analysis with longer follow-up of IRd therapy from the INSIGHT MM study (NCT02761187) and the Czech Registry of Monoclonal Gammopathies (RMG) to evaluate the effectiveness of IRd in RRMM pts in routine clinical practice. Methods INSIGHT MM is a large, prospective, observational study which has enrolled over 4,200 adult pts with MM from Europe (plus Israel, EUR), the US, Asia, and Latin America, with a planned follow-up of ≥5 years. The RMG comprises clinical data for 〉6,000 MM pts enrolled at 19 Czech and 4 Slovak centers. Eligible pts had 1-3 (INSIGHT) or ≥1 prior therapy (RMG) including an IR-based regimen. Individual pt level data on demographics, disease characteristics, treatment history, effectiveness, and safety from INSIGHT and RMG were integrated and analyzed. Best response or time to first response and PFS were determined as per investigator assessment, using IMWG criteria. PFS, duration of treatment (DOT), and overall survival (OS) were estimated using Kaplan Meier (KM) methodology, applying an exclusion criterion to account for immortal time bias (INSIGHT only). Results At data cutoff of 22 Nov 2018, 217 pts (83 in INSIGHT and 134 in RMG) from 11 countries had been included: 191 (88%) from EUR, 17 (8%) from the US, and 9 (4%) from Taiwan; 89% of pts were treated in an academic facility. At diagnosis, 32% of pts had ISS Stage III disease, 78% had bone lesions, 46% had anemia, and 12% had elevated creatinine. At study start, median age was 67 years with 12% 〉75 years; 58%/14% of pts had ECOG performance status 1/2. The distribution of immunoglobulin (Ig) heavy and light chain MM was as expected; 69% of pts had IgG MM. Overall, 21% of pts had extramedullary disease. Prior therapies included: bortezomib (90%), stem cell transplant (60%), thalidomide (47%), lenalidomide (26%), carfilzomib (8%), daratumumab (6%), and pomalidomide (2%). Median time from diagnosis to start of IRd therapy was 42.1 mos; 43%/35%/22% of pts received IRd at 2nd/3rd/≥4th line. The most common reasons for starting IRd were relapse/progression (87%) and insufficient response (10%). The most common CRAB criteria present were bone lesions (48%) and anemia (18%). Median duration of follow-up was 12.6 mos in all pts. At data cutoff, 117 (54%) pts had discontinued IRd; median DOT was 11.9 (95% CI: 9.4-15.2) mos; at 12 mos, 49% (41.3-56.2) of pts were still on treatment (KM estimates). Data on best response to therapy were available for 152 pts. The ORR was 74%, with 36% ≥VGPR; ORR with IRd at 2nd/3rd/ ≥4th-line therapy was 82%/71%/59%, including 43%/37%/17% ≥VGPR. Median time to first response was 1.2 mos (RMG); median time to best response was 3.7 mos (INSIGHT). Median PFS was 21.6 (95% CI: 13.6-26.7) mos across all lines. PFS rate at 12 mos was 62%, and 86 (40%) pts had progressed at data cutoff. Median time to next therapy (TTNT) was 31.5 (95% CI: 24.5-35.9) mos, with a 12-month rate of 74% across all lines. Overall, 60 (28%) pts received subsequent therapies including daratumumab (22%), pomalidomide (22%), bortezomib (20%), carfilzomib (17%), lenalidomide (15%), and thalidomide (12%). At data cutoff, 53 (24%) pts had died. Median OS was 36.7 (95% CI: 24.4-NR) mos, with 79% of pts alive at 12 mos (Figure). Regarding safety, ixazomib and lenalidomide dose reductions were required in 16% and 36% of pts, respectively, including 10% and 21% who required dose reductions due to AEs. Conclusions These findings show that the effectiveness of IRd in routine clinical practice (ORR 74%, median PFS 21.6 mos) is comparable to the efficacy of IRd reported in the registrational TOURMALINE MM1 trial (ORR 78%, median PFS 20.6 mos). IRd is well tolerated with no new safety signals, and low rates of dose reductions due to AEs for ixazomib (10%) and lenalidomide (21%). Outcomes should be interpreted with caution due to limited maturity of data. Disclosures Hajek: Janssen: Honoraria, Other: Consultant or advisory relationship, Research Funding; Amgen: Honoraria, Other: Consultant or advisory relationship, Research Funding; Celgene: Honoraria, Other: Consultant or advisory relationship, Research Funding; AbbVie: Other: Consultant or advisory relationship; Bristol-Myers Squibb: Honoraria, Other: Consultant or advisory relationship, Research Funding; Novartis: Other: Consultant or advisory relationship, Research Funding; PharmaMar: Honoraria, Other: Consultant or advisory relationship; Takeda: Honoraria, Other: Consultant or advisory relationship, Research Funding. Minarik:Celgene: Consultancy, Honoraria, Research Funding; Amgen, BMS, Janssen-Cilag, Takeda: Consultancy, Honoraria. Straub:Amgen, Takeda, Celgene: Consultancy. Berdeja:Amgen Inc, BioClinica, Celgene Corporation, CRISPR Therapeutics, Bristol-Myers Squibb Company, Janssen Biotech Inc, Karyopharm Therapeutics, Kite Pharma Inc, Prothena, Servier, Takeda Oncology: Consultancy; AbbVie Inc, Amgen Inc, Acetylon Pharmaceuticals Inc, Bluebird Bio, Bristol-Myers Squibb Company, Celgene Corporation, Constellation Pharma, Curis Inc, Genentech, Glenmark Pharmaceuticals, Janssen Biotech Inc, Kesios Therapeutics, Lilly, Novartis, Poseida: Research Funding; Poseida: Research Funding. Boccadoro:AbbVie: Honoraria; Mundipharma: Research Funding; Novartis: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding; Sanofi: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Janssen: Honoraria, Research Funding. Spencer:AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Haemalogix: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Secura Bio: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Servier: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Specialised Therapeutics Australia: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen Oncology: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. van Rhee:Karyopharm Therapeutics: Consultancy; Kite Pharma: Consultancy; Adicet Bio: Consultancy; EUSA: Consultancy; Castleman Disease Collaborative Network: Consultancy; Takeda: Consultancy; Sanofi Genzyme: Consultancy. Thompson:Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; VIA Oncology: Membership on an entity's Board of Directors or advisory committees; Adaptive: Membership on an entity's Board of Directors or advisory committees; UpToDate: Patents & Royalties: Myeloma reviewer; GSK: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Doximity: Equity Ownership, Membership on an entity's Board of Directors or advisory committees; AbbVie: Research Funding; BMS: Research Funding; Lynx Bio: Research Funding. Abonour:BMS: Consultancy; Celgene: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; Janssen: Consultancy, Research Funding. Chari:Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Oncoceutics: Research Funding; Novartis Pharmaceuticals: Research Funding; GlaxoSmithKline: Research Funding; Array Biopharma: Research Funding; Karyopharm: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Millennium/Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol-Myers Squibb: Consultancy; Pharmacyclics: Research Funding; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Sanofi: Membership on an entity's Board of Directors or advisory committees. Cook:Karyopharm: Consultancy, Honoraria, Speakers Bureau; Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau; Sanofi: Consultancy, Honoraria, Speakers Bureau; Takeda: Consultancy, Honoraria, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau. Costello:Takeda: Honoraria, Research Funding; Janssen: Research Funding; Celgene: Consultancy, Honoraria, Research Funding. Davies:Amgen, Celgene, Janssen, Oncopeptides, Roche, Takeda: Membership on an entity's Board of Directors or advisory committees, Other: Consultant/Advisor; Janssen, Celgene: Other: Research Grant, Research Funding. Hungria:Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Consultancy, Honoraria, Speakers Bureau; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Consultancy, Honoraria, Speakers Bureau; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Lee:Amgen: Consultancy, Research Funding; GlaxoSmithKline plc: Research Funding; Sanofi: Consultancy; Daiichi Sankyo: Research Funding; Celgene: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; Janssen: Consultancy, Research Funding. Leleu:Sanofi: Honoraria; Takeda: Honoraria; Oncopeptide: Honoraria; Karyopharm: Honoraria; Amgen: Honoraria; Carsgen: Honoraria; Incyte: Honoraria; Novartis: Honoraria; Celgene: Honoraria; Janssen: Honoraria; BMS: Honoraria; Merck: Honoraria. Puig:Takeda: Consultancy, Honoraria; The Binding Site: Honoraria; Janssen: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Rifkin:Takeda: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees. Terpos:Celgene: Honoraria; Takeda: Honoraria, Other: Travel expenses, Research Funding; Medison: Honoraria; Janssen: Honoraria, Other: Travel expenses, Research Funding; Amgen: Honoraria, Research Funding; Genesis: Honoraria, Other: Travel expenses, Research Funding. Usmani:Bristol-Myers Squibb: Consultancy, Research Funding; Sanofi: Patents & Royalties, Research Funding, Speakers Bureau; Janssen: Consultancy, Patents & Royalties, Research Funding, Speakers Bureau; Takeda: Consultancy, Patents & Royalties, Research Funding, Speakers Bureau; Celgene: Consultancy, Patents & Royalties, Research Funding, Speakers Bureau; Merck: Consultancy, Research Funding; Pharmacyclics: Patents & Royalties, Research Funding; Amgen: Consultancy, Patents & Royalties, Research Funding, Speakers Bureau; Array Biopharma: Patents & Royalties, Research Funding; Skyline DX: Consultancy. Weisel:Sanofi: Consultancy, Honoraria, Research Funding; Juno: Consultancy; GSK: Honoraria; Takeda: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Research Funding; Bristol-Myers Squibb: Consultancy, Honoraria; Celgene Corporation: Consultancy, Honoraria, Research Funding; Adaptive Biotech: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Research Funding. Zonder:Celgene Corporation: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Intellia: Consultancy, Membership on an entity's Board of Directors or advisory committees; Caelum: Consultancy, Membership on an entity's Board of Directors or advisory committees; Alnylam: Consultancy, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Oncopeptides: Consultancy, Membership on an entity's Board of Directors or advisory committees. Skacel:Millennium Pharmaceuticals, Inc., subsidiary of Takeda Pharmaceutical Company Limited: Employment. Elliott:Takeda: Employment. Demers:Takeda: Employment. Stull:Takeda: Employment. Ren:Takeda: Employment. Maisnar:Janssen, Amgen, Celgene, Takeda, BMS: Consultancy, Honoraria.

Description: Introduction Acquired severe aplastic anemia (SAA) is a low frequency hematologic disease associated with significant morbidity and mortality. The destruction by immunological mechanisms of hematopoietic progenitor cells appears to play a fundamental role in the pathophysiology of the disease, therefore, immunosuppressive treatment (IST) is one of the pillars of management. In Colombia and Latin-America there is lack of information about the characteristics of patients with SAA and the effectiveness of IST and other treatments. The main objective of this study was to assess the outcomes of a group of patients treated in different centers in Colombia during the last five years. Materials and methods This is a retrospective observational study, carried out within 6 institutions of 3 Colombian cities (Bogota, Medellín, Bucaramanga) of patients treated from 2013 to 2018. An anonymized database was constructed. All patients diagnosed with SAA and treated with IST as first line of therapy were included. Results We analyzed the data of 37 patients; 22 of them were women. The average age was 37 years old (with a range of 7-68 years). The median time since the onset of the symptoms to the time of diagnosis was 88 days (with a range of 7-655 days). Clastogenic effect of diepoxybutane (DEB) tests were available only in 9 patients (7 of which were positive); Paroxysmal Nocturnal Hemoglobinuria (PNH) clone was detected in 9 of the 27 tested, all of which were under 5%. Mean leukocytes, hemoglobin concentration, and platelets at the moment of diagnosis were 3.090, 8.5 and 22.000. Bacterial infection was the most important clinical manifestation at diagnosis (in 16 of the 37 patients); 19 out of 37 patients had more than 5 red blood cell transfusions before the first treatment. As first line therapy, 25 patients received IST (most by antithymocyte globulin (ATG) of which 10 were treated with rabbit ATG, 12 with horse ATG and 3 combined with Eltrombopag); 4 patients had cyclosporin and prednisone, 2 had allogeneic transplant and 6 received other therapies. Those treated with IST patients, 8 had a complete response (CR) (32%), 6 had partial response (PR) (24%), 8 had no response (32%). 5 received a second course of IST and 3 had CR. 3 patients were lost in follow up. At a mean follow up of 18.7 months (1.7-65), 44% were alive in CR, 26% in PR, 9% were in relapse and 21% died. Causes of death were SAA related infection in 5 patients, transplant related in 1 and non-disease related in 1. Conclusions This is the first multicenter report of SAA treatment in Colombia, it includes children and adults, resulting in a very heterogeneous population. This preliminary information shows that there is a significant delay in the diagnosis and initiation of treatment in patients, most patients have more than 5 transfusions before treatment. This could, in part, explain the apparent low response rates to IST in comparison to that of what have been reported in literature. A larger registry of hematologic pathologies is required so we can confirm these findings, start proposing strategies applicable in our country to achieve better outcomes in these patients and planning clinical trials to answer questions relevant to our population. Disclosures No relevant conflicts of interest to declare.

Description: Introduction: There are few reports of standard of care and outcomes in Latin America. The HOLA study is a retrospective chart review of patients with B-cell malignancies in Latin America (LATAM). Methods: The objective of this registry is to describe patient characteristics, diagnostic and treatment patterns, and clinical outcomes in patients with Chronic Lymphocytic Leukemia (CLL) from a mix of public and private sites in Brazil, Mexico, Chile, Argentina, Colombia, Guatemala, and Panama. We report 472 patients with CLL diagnosed in the period from January 2006 to March 2016. Results: Median age at diagnosis was 66 years (range 23 - 95). Male gender predominance (53.6 vs 46.4%). Twenty-three percent of the patients (n=103) were dead, median time from diagnosis to death of 2.4 years (range 0-6.6 years). Seventeen percent (n=19) died before frontline treatment, 35%(39) after first-line treatment, 19%(21) in second-line, 27%(30) at or after third-line treatment. Anemia reported on 34%. Of the 34% (n=162) patients with COOMBS test, it was positive on 13%. Frequent comorbidities were high blood pressure (46%), heart disease (17%) and diabetes (15%). Binet status reported on 63% of patients, Rai status on 55%. (Table 1) Flow cytometry missing on 27% of patients (not performed/missing report). Diagnostic markers were positive as follows: CD23, 94% and CD5, 92%. Prognostic markers: 52% tested for CD38 and 10% ZAP 70, positivity on 24% and 26% of tested patients, respectively. Cytogenetic/FISH test performed on 21% (102), del(17p) was present on 7.4% of tested patients at diagnosis. Seventy two per cent of patients were considered for watch- and-wait approach. Median time from diagnosis to treatment initiation was 113 days (range 1 -2808). Sixty one per cent (288/472) receive front line treatment at any time. Frequent reasons to start treatment were B symptoms (25%), anemia (21%) and lymphocyte doubling time

Description: Background Multiple myeloma (MM) is a frequent hematologic malignancy. The current gold standard frontline strategy includes a proteasome inhibitor (PI)-based induction, followed by autologous stem cell transplant (ASCT). Access to novel drugs in Latin America (LA) is limited. ASCT is available in most countries, but real access to it is highly heterogeneous. Data regarding patients´ outcomes in candidates to ASCT in the region is scarce. The aim of this study was to describe clinical characteristics and outcomes of MM transplant eligible patients in LA countries. Material and Methods Retrospective international multicenter cohort study. Consecutive MM transplant- eligible patients diagnosed between 2010 and 2018 from participating centers in Chile, Argentina, Ecuador, Mexico, Colombia, and Uruguay were included. Data were collected from clinical records in a standardized report form. We analyzed clinical characteristics at diagnosis and frontline therapy outcomes, including ASCT. Transplant-eligible patients were defined as fit patients younger than 66 years old. Active MM and response to treatment were defined according to current IMWG criteria. Inclusion criteria: 1.- Patients with newly diagnosed active MM between 2010 and 2018. 2.- Older than 18 years, and younger than 66 years. 3- Candidates for ASCT according to the evaluation of the attending physician Exclusion criteria: 1- Lack of minimum data in the clinical history 2- Plasma cell leukemia, AL amyloidosis or solitary plasmacytoma. 3- HIV infection 4-No consent and/or Ethics Committee approvals. Statistical analysis A descriptive statistic has been done. Comparisons of characteristics between groups was made usingT-student, Chi2 or ANOVA, as appropriate. Survival analysis was performed using Kaplan-Meier curves. Comparisons of survival between groups were made by the logarithmic recording method and the calculations of the risk relationships by Cox regression. Statistical analysis was performed by using STATA 13. Results We included 1293 patients in the study, 363 from Chile, 395 from Argentina, 209 from Colombia, 45 from Ecuador, 151 from Mexico, and 130 from Uruguay. The main characteristics at diagnosis and therapeutic strategies are shown in Table 1. Optimal response (sCR, CR and VGPR) was achieved in 38% of the patients in the cyclophosphamide, bortezomib, and dexamethasone (CyBorD) group, in 46% in the bortezomib, thalidomide, and dexamethasone (VTD) group, and in 36% in the cyclophosphamide, thalidomide, and dexamethasone (CTD) group, the 3 main induction regimens used. Only 53% of patients finally received ASCT. Significant differences were found between both groups, private and public institutions, regarding burden of symptoms, ISS staging, access to PI based induction, ASCT completion and adequate maintenance, with patients from the latter being more symptomatic, and receiving suboptimal therapy. FISH analysis was performed in less than 50% of patients, both in the public and private setting. With a median follow up of 34 months (range 1-113), median overall survival (OS) was 86 months. The 5-year progression free survival (PFS) was 38% and 5- year overall survival (OS) was 64%. When comparing public vs private settings, 5 year OS was 45% vs 80%, with a median OS of 56 months vs not reached, respectively (P

Description: Introduction Multiple myeloma (MM) has characteristics that influence the prognosis and are useful to make decisions regarding treatment. Diagnosis and treatment patterns of hematological malignancies have not been described in Colombia and having access to this regional information could guide public health policies and help design clinical trials. The Colombian Association of Hematology and Oncology (ACHO) designed a registry for Hemato-Oncological diseases to fill this information gap. This is the first report of RENEHOC focusing on MM. Methods We conducted an ambispective multi-centric cohort study of clinical records available from patients with MM that were diagnosed in the most populated regions of Colombia. We collected demographic, diagnostic, clinical and treatment data at different time points from diagnosis to the most current follow up. The computerized de-identified data was consolidated and analyzed using basic statistical measures of central tendency and dispersion. The most current follow up included data available from last clinic visit, loss of follow up, death or withdrawal of consent. This study was approved by local and centralized institutional review board. Results We analyzed data from 206 MM patients (pts). Average age at diagnosis was 62.9 (SD 10.2) years and 51.4% of pts were male. Most common symptoms at diagnosis were bone pain (74.2%), anemia related (58.2%) and pathological fractures (45.1%). Mean time from symptoms to diagnosis was 7.3 (Range 1-44) months. Baseline mean hemoglobin, creatinine and calcium serum levels were 10.5 g/dL, 1.58 mg/dL and 9.2 mg/dL respectively. At diagnosis, 22% of patients presented with renal failure and 30% required dialysis. Immunoglobulin (Ig) subtype distribution was: IgG 50.6%, IgA 20.6%, only light chain secretion (61% Kappa) and IgM 1.1%. In 11.6% all Igs were low. Most pts were diagnosed at advanced stages (64.5% Durie-Salmon III, and 37% and 47% International Staging System II and III respectively). Molecular prognostic characterization was performed only in 39 patients (18.4%). Four patients were considered too fragile for active treatment. The most common initial treatment was triple combinations that included Bortezomib (84% of patients). Among those, CyBorD was the most frequently used first line therapy (58.3%), followed by VTD (14.6%). Mean number of cycles was 4.8 (SD 2.5). Overall Response Rate (ORR) 74.7% was observed. Only 40% of patients treated with intense induction therapy received autologous transplant. Response to treatment including transplant are shown in table 1. Second and further lines of treatment were highly variable. 18 patients were treated with a second autologous transplantation consolidating 2nd line therapy. 12 patients received Carfilzomib combinations, all of them in 2nd line. 5 patients were treated with Daratumumab, all 〉2nd line. Mean follow-up time was 33.53 (SD 3.6) months. After a median follow up of 27 months we observed in our cohort an overall survival of 82% and 68% of patients progression-free. . Conclusions This first report focusing on MM highlights important differences on patient's characteristics and treatment in Colombian patients. This includes and treatment initiation due to insurance barriers; high risk clinical characteristics and complications upon diagnosis and low rate of transplantation in patients otherwise eligible for this procedure. Rates of response to induction seem slightly lower than reported (CB Reeder 2009). However, overall survival and progression-free survival met the expectations for this type of patients. The development of country specific databases may influence the design of policies, allocation and use of resources and improve patient outcomes. Only cooperative efforts like the one spearheaded by RENEHOC can achieve those goals. Disclosures No relevant conflicts of interest to declare.

Description: Aim: RENEHOC (Registro Epidemiológico de Neoplasias Hematológicas en Colombia) is a multicenter clinical quality database established in January 2018. The primary aim of the database is to provide local information on diagnosis and treatment of Multiple Myeloma (MM) and other hematologic neoplasms; this is key to show authorities the improvements that must be made to achieve better outcomes for Colombian patients and pose research questions relevant to our population. The aim of this report is to analyze variables related to event free survival (EFS) and overall survival (OS) in MM Colombian patients. Study population: An ambispective registry of adult MM patients, treated in approved centers over the last 10 years in Colombia. As of July 2020, 890 patients have been registered. Descriptive statistics were used for patient's demographic and clinical characteristics. The Kaplan-Meier method was used to assess DFS and OS. Hazard Ratios (HR) using Cox proportional hazards regression modeling was estimated.

Description: Background Multiple myeloma (MM) is a heterogeneous and incurable disease that evolves from asymptomatic premalignant conditions. The worldwide incidence, prevalence and mortality are well known thanks to data reported by the International Agency for Research on Cancer (IARC) and by the GLOBOCAN World Cancer Observatory. The data provided by Colombia to these reports comes from the population cancer registries corresponding to 5 cities whose most up-to-date data are from 2018. National data can also be found in the base of the high-cost account. Although it is true that there are excellent sources of information, it is believed that there is a significant underreporting of the prevalence of the disease, which makes it necessary to optimize the information to achieve the establishment of programs oriented to work on better control of this type of hematological cancer. The study MiMENTe (Mieloma Múltiple Epidemiología Nacional y territorial) is a collaborative effort to know the reality of the disease in terms of incidence, prevalence and mortality in Colombia as a first step to control the disease even in the premalignant stages for the future wanting to position itself as a model for the control of MM in developing countries. Methods MiMENTE (Mieloma Múltiple, Epidemiología Nacional y territorial) is a multiphase study that is going through its first stage through a cross-sectional study in Colombia. The total population diagnosed with Multiple Myeloma (ICD Code 10 C900) during the 2008-2018 period was included in the RIPS Individual Service Delivery Registry in Colombia and a comparison was made with the available data from GLOBOCAN (Global Cancer Observatory) and High Cost Account. Records that had an unidentified diagnosis were excluded. For this phase, a comparison is made of the data from the registries of the three entities described, three measures of frequency are established: Incidence, prevalence and mortality, standardizing the latter by means of a direct method, making the Colombian population comparable with large countries such as the United States. and Spain cataloged as centers of reference in the management and diagnosis of Multiple Myeloma. Variables such as ethnicity, age, place of origin, health regime, place of death will be studied in the future in later phases of the study. Results Between 2009 and 2018 (10 years), 26,356 MM diagnoses were found throughout the national territory of Colombia. The departments where the most attention to patients with this diagnosis was presented were Cundinamarca, Valle del Cauca, Antioquia, Santander, Bolívar and Atlántico Figure 1. The standardized incidence rate for Colombia in 2018 was 1.79 x 100,000 inhabitants, being higher in the Andean region as shown in the heat map. Graph 1. The total number of prevalent cases per year varied from 1138 cases in 2009 to 4474 cases in 2018 being for this year the adjusted prevalence of 8.97 x 100,000 inhabitants / year Graph 2. When the prevalence is analyzed by regions it is higher in the Andean region Graph 3. During this entire period of time, 5481 deaths were found, being 20.80%. The highest mortality occurred in the departments of Vichada, Meta, Caquetá, Risaralda, Atlántico and the island of San Andrés. Figure 2. The age-standardized mortality rate for Colombia is 1,39x100,000 inhabitants (Adjusted with the population of the United States). The most up-to-date data from IARC and GLOBOCAN are those corresponding to the year 2018. A comparison was made of our data with those reported in this last registry for Colombia in addition to the high-cost account. Comparative data were developed with the population of the United States, standardizing this population and it was also compared with the data reported for Spain. The prevalence of the disease is higher in Colombia than reported by GLOBOCAN, IARC and High cost drug account Table 1. Conclusion This is the first report of the MiMENTe study that shows the incidence, prevalence and mortality of patients with 10-year-old multiple myeloma in Colombia. The prevalence of the disease is higher than that reported by international registries. The regions with the highest incidence were those belonging to the andean region. The highest prevalence was confirmed in Bogotá and Antioquia and the highest mortality was observed in the Orinoco region. Disclosures Idrobo: Takeda: Honoraria, Speakers Bureau; Janssen: Honoraria, Speakers Bureau; Tecnofarma: Honoraria, Speakers Bureau; Amgen: Honoraria, Speakers Bureau; Abbvie: Honoraria, Speakers Bureau.