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Objectives This study compared the use of bortezomib in different combination regimens in newly diagnosed multiple myeloma (NDMM) patients who were transplant ineligible. Patients and methods We analyzed data from the Registry of Monoclonal Gammopathies (RMG) of the Czech Myeloma Group (CMG) to provide real-world evidence of outcome for 794 newly diagnosed MM transplant ineligible patients. The most frequently used regimen was VCd (bortezomib-cyclophosphamide-dexamethasone) (47.5%) over VMP (bortezomib-melphalan-prednisone) (21.7%), BDd (bortezomib-doxorubicin-dexamethasone) (9.8%) and VTd (bortezomib-thalidomide-dexamethasone) (2.9%). Results The overall response rate (ORR) was 69.2% (478/691), including 12.6% (≥ CR); 34.7% very good partial responses (VGPR); 21.9% partial responses (PR). Among triplet regimens, VMP was the most effective regimen compared to VCd, BDd and VTd. Median PFS was 22.3 vs. 18.5 vs. 13.7 vs. 13.8 months, (p=0.275), respectively and median OS was 49 vs. 41.7 vs. 37.9 vs. 32.2 months (p=0.004), respectively. The most common grade 3-4 toxicities were anemia in 17.4% and infections in 18% of patients. Conclusion Our study confirmed that bortezomib-based treatment is effective and safe in NDMM transplant ineligible patients; especially VMP, which was identified as superior between bortezomib-based induction regimens not only in clinical trials, but also in real clinical practice.

Background COVID-19 disease caused by SARS-CoV-2 coronavirus has affected millions of people worldwide. The mortality of this infection varies with age and comorbidities up to more than 10% in very elderly population. The aim of our study was to determine the disease pattern and mortality rate among multiple myeloma patients. Methods We retrospectively analyzed entries in the Czech Registry of Monoclonal Gammopathies from patients who were infected with SARS-CoV-2 from March 2020 until May 2021. Demographic data, treatment patterns, comorbidities, symptoms of COVID-19, treatment modalities and healthcare utilization was compared in survivors and non-survivors. Results Overall, 371 patients with MM and COVID-19 infection were identified. Median age at covid-19 diagnosis was 69 years (37-91 years), 53.4% (198/371) were males. There were 70.1% (260/371) survivors and 20.8% (77/371) deceased patients, outcome of 9.2% (34/371) of patients is unknown. PCR positivity was seen with median 20 days (1-84 days) in 79 evaluable patients. 6 patients were vaccinated prior to infection (5-68 days). Infection was acquired during actual treatment in 53.1% of patients (197/371). Median number of previous lines administered was 1 (0-7). Treatment preceding infection was most frequently composed of lenalidomide in 50.3%, bortezomib in 42.1% and daratumumab in 19.8%. Symptomatic infection was seen in 74.9% (278/371) of patients with fever being the leading symptom (49.6%) followed by cough (39.1%) and shortness of breath (35.0%). Inpatient treatment was needed in 45.0% (167/371) of patients, intensive care unit was required in 38.9% (65/167) of patients. Median length of in-hospital stay was 11 days (1-53 days). Artificial lung ventilation was necessary in 10.8% (18/167) patients, 24.6% (41/167) needed non-invasive ventilation or high flow oxygen and 35.3% (59/167) of patients needed low flow oxygen. Remdesivir was administered to 10.0% (37/371) and convalescent plasma to 4.9% (18/371) of patients. No difference was seen in mortality according to ISS stage (p=0.609), administered lines of therapy (p=0.119) or achieved treatment response (p=0.418). Conclusions The mortality of MM patients with COVID-19 was very high (20.8%). Healthcare utilization was high with almost half of the infected myeloma patients needing inpatient treatment. No apparent risk factors in terms of disease status or previous treatment were identified. Supported by MH CZ - DRO (UHHK, 00169906) and by the program PROGRES Q40/8.

The definition of complete disease response (CR) in multiple myeloma (MM) continues to be reevaluated. The last widely accepted model of response assessment was proposed by the International Myeloma Working Group (IMWG) in 2016.1 Urine immunofixation (uIFE), one of the CR parameters, is being frequently omitted from CR evaluation in routine clinical practice. Patients with missing uIFE are then reported as having very good partial response (VGPR).2 It has been recently suggested in retrospective analysis by Lahuerta et al3 that patients with intact immunoglobulin myeloma (IIMM) who lack uIFE examination present with the very same prognosis as the patients with negative uIFE and therefore uIFE might not be necessary for CR definition in such patients.

Monoclonal gammopathy of undetermined significance (MGUS) is a benign condition with an approximate 1% annual risk of symptomatic plasma cell disorder development, mostly to multiple myeloma (MM). We performed genomewide screening of copy-number alterations (CNAs) in 90 MGUS and 33 MM patients using high-density DNA microarrays. We identified CNAs in a smaller proportion of MGUS (65.6%) than in MM (100.0%, P = 1.31 × 10-5 ) and showed median number of CNAs is lower in MGUS (3, range 0-22) than in MM (13, range 4-38, P = 1.82 × 10-10 ). In the MGUS cohort, the most frequent losses were located at 1p (5.6%), 6q (6.7%), 13q (30.0%), 14q (14.4%), 16q (8.9%), 21q (5.6%), and gains at 1q (23.3%), 2p (6.7%), 6p (13.3%), and Xq (7.8%). Hyperdiploidy was detected in 38.9% of MGUS cases, and the most frequent whole chromosome gains were 3 (25.6%), 5 (23.3%), 9 (37.8%), 15 (23.3%), and 19 (32.2%). We also identified CNAs such as 1p, 6q, 8p, 12p, 13q, 16q losses, 1q gain and hypodiploidy, which are potentially associated with an adverse prognosis in MGUS. In summary, we showed that MGUS is similar to MM in that it is a genetically heterogeneous disorder, but overall cytogenetic instability is lower than in MM, which confirms that genetic abnormalities play important role in monoclonal gammopathies.

This study used data from the Czech Myeloma Group Registry of Monoclonal Gammopathies to validate the International Myeloma Working Group (IMWG) and revised International Staging System (R‐ISS) indices for risk stratification in patients with multiple myeloma (MM) in clinical practice. Patients were included if they had symptomatic MM, complete data allowing R‐ISS and IMWG staging (including cytogenetic information regarding t(4;14), t(14;16), and del(17p)), and key parameters for treatment evaluation. Median overall survival (OS) in included patients (n = 550) was 47.7 (95% CI: 39.5‐55.9) and 46.2 (95% CI: 38.9‐53.5) months from diagnosis and initiation of first‐line therapy, respectively. Patients categorized as higher vs lower risk had reduced survival; median OS from diagnosis was 35.4 (95% CI: 30.5‐40.3) vs 58.3 (95% CI: 53.8‐62.9) months in high‐risk vs other patients (IMWG; P = .001) and 34.1 (95% CI: 30.2‐38.0) vs 47.2 (95% CI: 43.4‐51.0) months in Stage III vs Stage II patients (R‐ISS; P

IntroductionMonoclonal gammopathy of undetermined significance (MGUS) is a premalignant condition with a risk of malignant conversion. Patients and methodsWith the aim to estimate the cumulative risk MGUS progression to hematologic malignancies, we analyzed a nationwide population-basedcohort of 1887 MGUS patients from the Czech Registry of Monoclonal Gammopathies (RMG) between 2007 and 2013. ResultsDuring the follow-up period (median 4years; range 0.6-34.8), progression to hematologic malignancies was observed in 8.6% (162 of 1887) of patients. Factors associated with progression were as follows: M-protein concentration 1.5g/dL, pathological sFLC ( 1.65) ratio, bone marrow plasma cells (BMPCs) in cytology >5%, immunoparesis, age 69years, and the level of serum hemoglobin at baseline

We analyzed 1156 multiple myeloma (MM) patients treated with thalidomide. The overall response rate was 63.6%, with complete remission in 13.4%. Combined regimens had better outcomes than thalidomide plus dexamethasone or single agent thalidomide. Thalidomide was not able to overcome adverse cytogenetics. Superior results were seen in patients undergoing subsequent autologous stem cell transplantation. The rate of adverse events was low. Thalidomide has a strong potential to improve response and survival measures in patients with standard risk MM. Combined regimens should be used, with lower doses of thalidomide. High risk myelomas should be treated individually.

OBJECTIVE:Subcutaneous (SC) application of bortezomib has been recently introduced as a new application route in multiple myeloma (MM) patients. We performed an analysis to compare the outcomes of bortezomib-based therapy in multiple myeloma (MM) patients treated using either intravenous (IV) or subcutaneous (SC) route of administration. PATIENTS AND METHODS:During January 2012 through December 2013, we performed a retrospective analysis of 446 patients with MM treated with bortezomib-based regimens (either once weekly - 63% or twice weekly - 27%) in both, the first line setting, and in relapse, with separate analysis of patients undergoing autologous stem cell transplantation. We assessed the response rates and toxicity profiles in both, IV and SC route of bortezomib administration. RESULTS:The response rates in both IV and SC arm were similar with overall response rate 71.7% vs 70.7%, complete remissions in 13.9% vs 8.6%, very good partial remissions in 30.8% vs 34.5% and partial remissions in 27% vs 27.6%. The most frequent grade ≥ 3 toxicities were anemia, thrombocytopenia and neutropenia, with no significant differences between IV and SC group. There were no significant differences in the rate of peripheral neuropathy (PN). PN of any grade was present in 48% in the IV arm and in 41% in the SC arm. PN grade ≥ 2 was present in 20% vs 18% and PN grade ≥ 3 was present in 6% vs 4%. CONCLUSIONS:We conclude that subcutaneous application of bortezomib has similar therapeutic outcomes and toxicity profile as intravenous route of application. In our cohort there was no difference in the incidence of PN, suggesting that PN is dose dependent and might be reduced by lower intensity schemes rather than by the route of administration.

e120 Conclusion: Our data suggests that AKI due to ATN at the time of myeloma diagnosis is more likely to recover compared to MCN with a faster time to response. However this does not seem to affect overall survival.

Abstract 1872 Background: Bortezomib (Velcade) is one of the most effective treatment options in the treatment of relapsed or refractory multiple myeloma (RRMM). In the Czech Republic, it has been available since 2004. Registry of monoclonal gammopathy (RMG) of the Czech Myeloma Group contains information of more than 90% of patients in the Czech Republic treated with novel drugs.Aims: The aim of this retrospective analysis was to verify the therapeutic efficacy and safety of bortezomib in the treatment of RRMM in the Czech Republic. Methods: Before inclusion to RMG, all persons signed the informed consent form. In total, 1469 MM patients treated with bortezomib were evaluated from the RMG between June 2004 and December 2011.A total of 51.5% (750/1469) RRMM patients were analyzed with follow-up ≥6 months from the start of first administration of bortezomib. 30.6% (450/1469) patients with newly diagnosed MM were excluded from the analysis as well as 18.2% (267/1469) with a short follow-up. Evaluation of treatment response was performed according to the IMWG criteria. Median patient age was 65 years (range 33.9–88.1), median time since starting therapy was 21.5 months (range 6.1– 86.2), median number of previous treatments was 3.0 (range 1.0–8.0). In total, 92% (690/750) patients finished treatment of bortezomib (cycles length 21–28 days with application on days 1, 4, 8,11 or 1, (4), 8, 15 for frail patients). Median number of bortezomib cycles delivered was 6 (0.5–15.5). Results: Assessment of therapeutic response was possible in 92% (690/750) of treated patients. Overall response (ORR) in 57.5% (397/690) patients including 3% sCR, 8% CR, 20.3% VGPR, 26.2% PR. Stable disease was confirmed in 11.4% (79/690) patients and 22.5% (155/690) patients had progressive disease. In 50.1% of responders, first response (≥MR; defined as a ≥25% decrease in the serum MIg) occurred within the first cycle. At the second cycle, 24.2% of responders started to respond. Median time to progression (TTP) for all responders was 12.4 months. Median overall survival after starting bortezomib therapy (OS) was 32.3 months for all responders. Altogether, 692 adverse events (AEs) were documented. The most frequent AEs were: anemia in 62% of patients (462/750); severity of anemia was distributed as follows: 33.3% (250/750) cases of grade 1, 28.3% (212/750) cases of grade 2. Thrombocytopenia grade 3 and 4 was seen in 21.5% (161/750) of patients. Pre-existing peripheral neuropathy (PNP) grade 1–2 was presented in 25.1% (191/750) of patients at the start of bortezomib treatment. After treatment of bortezomib, PNP could be documented in 59.3% (445/750) cases with 16% (71/445) cases of grade 3 and 0.7% (3/445) cases of grade 4 PNP. In subanalysis, groups of patients were compared with relapsed patients who were treated with bortezomib in the second, third or greater-line of therapy. Among these three groups, there were significant differences in the evaluation of ORR (59.8% vs. 53.4% vs. 46.8%, p=0.022), as well as the sCR+CR was dependent on the number of previous treatment lines (15.6% vs 7.3% vs. 1.4%; p Conclusion: Our results show that bortezomib is one of the highly effective drugs for patients with RRMM. In current practice, the benefit (measured TTP) is 10–14 months, according to severity of the disease with a favorable impact on overall survival even in heavily pretreated patients. Implementation of autologous stem cell transplantation in relapsed disease following bortezomib treatment had a beneficial effect on overall survival. Acknowledgments: This work was supported by IGA NT 12130–4 and IGA NT 12215–4 grants. Disclosures: Maisnar: Janssen Cilag: Honoraria; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Bayer (Schering): Honoraria. Hajek:Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen Cilag: Honoraria.

Introduction: Revised prognostic scoring system R-ISS (standard ISS plus cytogenetic changes) has been introduced as a possible tool for evaluation of patients with multiple myeloma. This system is based on pooled data from various clinical trials but has not been validated in patients´ population outside the clinical trial setting. Aim: To evaluate clinical relevance of R-ISS in real life population of multiple myeloma patients. Methods: Registry of monoclonal gammopathies (RMG) was established in 2007 and has become one of the flagship projects of the Czech Myeloma Group. The registry collects prospective data from patients with myeloma and other gammopathies (https://trials.cba.muni.cz/trialdb2/interface_forms/login_rmg.asp). Registry is regularly monitored and data are validated by an external monitor. Data from registry were retrieved to identify patients in whom all above mentioned parameters were available. These patients were then stratified according to R-ISS and TTP and OS were calculated as primary endpoints. Results: 555 patients (260 females, 295 males, median age 66 years) with multiple myeloma who had full set of necessary data available were identified. Median follow-up of this cohort was 22.2 months. 97 17.5% (97/555) patients were R-ISS stage I, 55.7% 309/555 were R-ISS stage II and 26.8% (149/555) patients were R-ISS III. Median overall survival was not reached for stage I, 3.9 years for stage II and 2.5 years for stage III. The differences were statistically significant (p Conclusion: Revised ISS provides valuable information about the long term prognosis in a mixed cohort of real life multiple myeloma patients. This system enables to estimate the prognostic category of each specific patient in a horizon of several years ahead. Supported by PRVOUK P37. Table 1 Table 1. Figure 1 Overall survival for R-ISS stages Figure 1. Overall survival for R-ISS stages Figure 2 Time to progression for R-ISS stages Figure 2. Time to progression for R-ISS stages Disclosures Spicka: BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen Cilag: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Honoraria; Millenium: Honoraria. Hájek:Janssen: Honoraria; Celgene: Consultancy, Research Funding; BMS: Honoraria; Amgen: Consultancy, Honoraria, Research Funding; Takeda: Consultancy.

Background:Subcutaneous (SC) application of bortezomib has been recently introduced as a new application route in multiple myeloma (MM) patients. The results of an international randomized phase III trial confirmed that SC application of bortezomib is not inferior to intravenous (IV) route, with similar response rates and improved toxicity profile. Our aim was to confirm the results on a larger cohort of patients treated with IV or SC bortezomib in 2-year period within the Czech Myeloma Group. Patients and methods: We performed a retrospective analysis of 262 patients with MM treated with bortezomib based regimens during 2012-2013 in the Czech Republic. In total, there were 177 patients in the IV arm and 85 patients in the SC arm. Patients undergoing high-dosed chemotherapy followed by autologous stem cell transplantation (ASCT) were assessed separately (N = 99). There were 164 patients treated in the first line setting and 98 patients in relapse/progression of MM. The patients received up to eight 28-day cycles of bortezomib-based regimen with bortezomib dose 1.3mg/m2. The regimens used were following: CVD (cyclophosphamide, bortezomib, dexamethasone) in 58.2%/60.0%, VD (bortezomib, dexamethasone) in 10.7%/9.4%, BDD (bortezomib, doxorubicin, dexamethasone) in 9.6%/14.2%, VMP (bortezomib, melphalan, prednisone) in 6.0%/9.0%, bortezomib monotherapy in 1.1%/1.2%, BBD (bortezomib, bendamustine, dexamethasone) in 1.1%/2.4%, BP (bortezomib, prednisone) in 0%/1.6%, and other in 13.6%/2.4%. In order to reduce neurological toxicities, most of the patients received bortezomib once weekly. In both IV and SC arms we assessed the demographics and baseline characteristics, response rates and toxicities. For statistical estimation we used Mann-Whitney U test and Chi-square test at p < 0.05. Results:There were mild differences in the age and gender between IV and SC arms (median age 71.3 vs 67.9 years, p = 0.024; M/F ratio 1.4:1 vs 0.6:1, p = 0.007), other variables were without significant difference, including laboratory parameters (M-protein, hemoglobin, thrombocyte count, serum calcium level, albumin, creatinine, beta-2-microglobulin, lactate dehydrogenase, CRP), line of chemotherapy (first line, second line, third line and fourth and higher line) and therapeutic regimen used. Patients received median of 6 cycles in the IV group and 5 cycles in the SC group. The rates of response were similar in both, IV and SC arms with overall response rate (ORR) 71.7% vs 70.7%, complete remissions (CR) including stringent complete remissions (sCR) in 13.9% vs 8.6%, very good partial remissions (VGPR) in 30.8% vs 34.5% and partial remissions (PR) in 27% vs 27.6%. Toxicities were present in most patients (up to 99%), prevailing grade 1-2 toxicities, the most frequent grade ≥3 toxicities were anemia, thrombocytopenia and neutropenia, with no significant differences between IV and SC group. There were no significant differences in the rate of peripheral neuropathy (PN). PN of any grade was present in 48% patients in the IV arm and in 41% in the SC arm. PN grade ≥2 was present in 20% vs 18% and PN grade ≥3 was present in 6% vs 4% (p = 0.782). Conclusions:Subcutaneous application of bortezomib has similar therapeutic outcomes and toxicity profile as intravenous route of application. In our cohort there was no difference in the incidence of PN, suggesting that PN is dose dependent and might be reduced by lower intensity schemes rather than by the route of administration. Supported by the grants IGA MZ CR NT 14393, NT 12215-4/2011, NT 14400, NT12451-5, NT 12215-4, and the grant MSM0021622434. Disclosures No relevant conflicts of interest to declare.

Introduction: Collection of valid data in patients with hematologic malignancies remains a challenge. Especially low grade malignancies require long term follow-up and valid high quality data. The RMG registry was established in 2007 and has become one of the flagship projects of the Czech Myeloma group. To date, four parts of the registry are active - module for multiple myeloma (MM), monoclonal gammopathies of undetermined significance (MGUS), AL amyloidosis (ALA) and Waldeströms macroglobulinemia. The later two has been started in 2014. Aim: To analyze current status of the registry in terms of amount of contained data. Methods: All patients must sign a written consent before entering their data into the registry. Data concerning diagnosis, demography, treatment and survival are regularly collected and updated into the registry via online system at https://trials.cba.muni.cz/trialdb2/interface_forms/login_rmg.asp. The data from MGUS patients are retrospective and prospective, data from MM patients are only prospective (since 2007). Registry is regularly monitored and data are validated by an external monitor. Results: There are 22 participating centers as of July 2015 (18 from the Czech Republic and 4 from Slovakia). Data from 4549 patients with MM, 2168 with MGUS, 121 patients with WM and 22 with ALA have been collected. Together 6860 patients have been included in the registry as of July 2015. Median follow-up of MGUS patients is 4 years (0-35 years) and median follow-up for MM patients is 2 years (0-32 years). The huge amount of data allowed publication of treatment results of MM patients treated with bortezomid and thalidomide in the Czech Republic and regular analysis of patients treated with lenalidomide. Novel prognostic models for MGUS progression and asymptomatic myeloma have been created based on registry data (manuscripts submitted). Conclusion: The RMG is one of the largest registries in Europe. Its biggest advantage is collection of validated updated data which can be used to create rapid analyses in order to react to changing myeloma field. It helps us to create new guidelines and serves as a potent research tool. It can be also used to negotiate reimbursement with healthcare insurance companies and government regulatory authorities for novel drugs implementation into treatment standards. Supported by The Ministry of Education, Youth and Sports (Specific university research of the Faculty of Medicine, University of Ostrava) project no. SGS01/LF/2014-2015, by the Moravian-Silesian Region - grant no. MSK 02692/2014/RRC, by the Institutional Development Plan of University of Ostrava in 2015, financial resources are allocated by The Ministry of Education, Youth and Sports. Supported by grant NT14575. Disclosures Hajek: Amgen: Honoraria; Celgene: Consultancy; Janssen: Consultancy.

BACKGROUND: The European Commission has granted conditional approval to daratumumab (DARA) as monotherapy in adult patients (pts) with relapsed or refractory multiple myeloma (MM) whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and who have demonstrated disease progression on the last therapy. DARA was approved under an accelerated assessment based on single-arm phase 2 studies. Outcomes in these heavily pretreated pts in a real-world (RW) setting can provide evidence on the relative treatment efficacy of DARA versus physician's choice (PC). AIMS: To perform an adjusted comparison of overall survival (OS) and progression-free survival (PFS) for DARA monotherapy versus PC, as observed in a RW historical cohort of heavily pretreated and highly refractory MM pts from the Czech Republic using pt-level data. METHODS: Using RW longitudinal pt chart data from the Registry of Monoclonal Gammopathies (RMG) of the Czech Myeloma Group, pts with ≥2 prior lines of therapy previously exposed to both a PI and an IMiD were identified. Pt-level data from the RMG were pooled from pivotal DARA monotherapy studies (pts treated with DARA 16 mg/kg). Pts in the RMG could contribute information to the analysis for multiple lines of therapy, with baseline defined as the date of initiation of the actual treatment line. For the definition of PFS, missing data for the date of disease progression for pts in the RMG who initiated subsequent therapy were replaced by the conservative proxy of the date of initiation of the next treatment. OS and PFS were analysed using a Kaplan-Meier analysis. To adjust for confounding variables, a multivariate Cox proportional hazards regression was developed that included age, gender, beta-2 microglobulin levels (β2M : 5.5 g/L), albumin levels ( RESULTS: From the RMG database, we identified 971 treatment lines in 463 pts previously exposed to both a PI and an IMID (n=206 in third line, n=256 in fourth line, n=203 in fifth line, n=307 in ≥sixth line). The dates of treatment initiation for the RMG pts ranged from March 2006 to March 2015. The most frequent treatment regimens were lenalidomide (33.4%), chemotherapy (18.1%), bortezomib (13.6%), thalidomide (8.0%), and bortezomib+thalidomide (5.3%). The number of pts treated with carfilzomib (2.5%) and pomalidomide (2.4%) was limited. DARA-treated pts (N=148) differed from the RMG cohort in median age (64 vs 62 years), median prior lines of therapy (5 vs 4), prior exposure to carfilzomib (41.2% vs 0.3%) and pomalidomide (55.4% vs 0.6%), thrombocytopenia incidence (46.9% vs 18.0%), and ≥triple refractory status (64.2% vs 5.3%). Median observed PFS and OS for DARA versus PC were 4.0 and 5.6 months, respectively, for PFS and 20.1 and 11.9 months, respectively, for OS. Older age, male sex, low albumin levels, high β2M levels, thrombocytopenia incidence, and double/triple/quadruple refractory status were all independent, statistically significant risk factors for mortality. Albumin levels, β2M levels, thrombocytopenia incidence, and refractory status were also predictive of PFS. The adjusted hazard ratio (95% confidence interval) for OS and PFS for DARA versus PC was 0.35 (0.22-0.56) and 0.79 (0.56-1.12), respectively. Figure 1 represents the predicted survival curves for the RMG cohort that were derived from the multivariate model, comparing observed PFS/OS versus predicted with DARA treatment. CONCLUSIONS: This adjusted treatment comparison suggests a significant improvement in OS and a numerical improvement in PFS for DARA compared to RW historical control data in heavily pretreated/highly refractory MM pts. The lower PFS benefit estimate for DARA compared to OS may be partly explained by limitations in the availability and comparability of data regarding progressive disease in the RMG cohort compared to clinical trial data. Adjusted comparisons between trial data and historical cohorts can provide useful insights to clinicians and reimbursement decision makers on relative treatment efficacies in the absence of head-to-head comparison studies for DARA monotherapy. Disclosures Hájek: Amgen: Honoraria, Research Funding; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Research Funding; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Research Funding. Spicka:BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Millenium: Honoraria; Amgen: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen Cilag: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Gatopoulou:Janssen Health Economics & Market Access EMEA: Employment. Vesela:Janssen Cilag s.r.o., Czech Republic: Employment. Diels:Johnson & Johnson: Employment, Equity Ownership. Besson:Janssen: Employment. Ito:Janssen: Employment, Equity Ownership.