Abstract: Transient self‐assembly of dipeptide nanofibers with lifetimes that are predictably variable through dipeptide sequence design are presented. This was achieved using 1,8‐naphthalimide ( NI ) amino acid methyl‐esters (Phe, Tyr, Leu) that are biocatalytically coupled to amino acid‐amides (Phe, Tyr, Leu, Val, Ala, Ser) to form self‐assembling NI ‐dipeptides. However, competing hydrolysis of the dipeptides results in disassembly. It was demonstrated that the kinetic parameters like lifetimes of these nanofibers can be predictably regulated by the thermodynamic parameter, namely the self‐assembly propensity of the constituent dipeptide sequence. These lifetimes could vary from minutes, to hours, to permanent gels that do not degrade. Moreover, the in‐built NI fluorophore was utilized to image the transient nanostructures in solution with stimulated emission depletion (STED) based super‐resolution fluorescence microscopy.

Abstract: Autologous stem cell transplantation (ASCT) followed by lenalidomide maintenance therapy is the standard of care for transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). Clinical trials show progression-free survival (PFS) benefits, with some studies (Cancer and Leukemia Group [CALGB] trial and meta-analysis) also showing overall survival (OS) benefits, but applicability to real-world clinical settings is unclear. Using data from Connect MM, the largest US-based observational registry of NDMM patients, we analyzed effects of maintenance therapy on long-term outcomes in 1450 treated patients enrolled from 2009 to 2011. Patients who received induction therapy and ASCT (n = 432) were analyzed from 100 days post-ASCT (data cut 7 January 2016): 267 received maintenance (80% lenalidomide-based [of whom 88% received lenalidomide monotherapy] ); 165 did not. Lenalidomide maintenance improved median PFS and 3-year PFS rate vs no maintenance (50.3 vs 30.8 months [hazard ratio (HR), 0.62; 95% confidence interval (CI), 0.46-0.82; P & lt; .001] and 56% vs 42%, respectively). Improvements in median OS and 3-year OS rate were associated with lenalidomide maintenance vs no maintenance (not reached in either group [HR, 0.54; 95% CI, 0.36-0.83; P = .005] and 85% vs 70%, respectively). Five hematologic serious adverse events were reported with lenalidomide maintenance (pancytopenia [n = 2], febrile neutropenia, anemia, and thrombocytopenia [n = 1 each] ) and 1 with no maintenance (thrombocytopenia). Second primary malignancies occurred at rates of 1.38 and 2.19 events per patient-year in lenalidomide maintenance and no maintenance groups, respectively. Survival benefits associated with lenalidomide maintenance previously demonstrated in clinical trials were observed in this community-based Connect MM Registry.

Abstract: Background: Multiple myeloma (MM) is common among the elderly, with 35% of patients (pts) diagnosed being aged ≥75 years (y). With increasing overall life expectancy, the incidence and prevalence of newly diagnosed and previously treated MM patients ≥80 y is expected to increase over time. Because elderly pts are often excluded from clinical trials, data focused on their treatment patterns and clinical outcomes are lacking. The Connect® MM Registry (NCT01081028) is a large, US, multicenter, prospective observational cohort study of pts with newly diagnosed MM (NDMM) designed to examine real-world diagnostic patterns, treatment patterns, clinical outcomes, and health-related quality of life patient-reported outcomes. This analysis reviews treatment patterns and outcomes in elderly pts from the Connect MM Registry. Methods: Pts enrolled in the Connect MM registry at 250 community, academic, and government sites were included in this analysis. Eligible pts were adults aged ≥18 y with symptomatic MM diagnosed ≤2 months before enrollment, as defined by International Myeloma Working Group criteria; no exclusion criteria were applied. For this analysis, pts were categorized into 4 age groups: 〈 65, 65 to 74, 75 to 84, and ≥85 y. Pts were followed from time of enrollment to the earliest of disease progression (or death), loss to follow-up, or data cutoff date of February 7, 2019. Descriptive statistics were used for baseline characteristics and treatment regimens. Survival outcomes were analyzed using Cox regression. Time to progression (TTP) analysis excluded causes of death not related to MM. Results: Of 3011 pts enrolled (median age 67 y), 132 (4%) were aged ≥85 y, and 615 (20%) were aged 75-84 y at baseline. More pts aged ≥85 y had poor prognostic factors such as ISS stage III disease and reduced hemoglobin ( 〈 10 g/dL or 〉 2 g/dL 〈 LLN) compared with other age groups, although no notable differences between creatinine and calcium levels were observed across age groups (Table). A lower proportion of elderly pts (75-84 and ≥85 y) received triplet regimens as frontline therapy. More elderly pts received a single novel agent, whereas use of 2 novel agents was more common in younger pts (Table). The most common frontline regimens among elderly pts were bortezomib (V) + dexamethasone (D), followed by lenalidomide (R) + D, whereas those among younger pts included RVD, followed by VD and CyBorD (Table). No pt aged ≥85 y, and 4% of pts aged 75-84 y received high-dose chemotherapy and autologous stem cell transplant (vs 61% in the 〈 65 y and 37% in the 65-74 y age group). The most common maintenance therapy was RD in pts ≥85 y (although the use was low) and R alone in other age groups (Table). In the ≥85 y group, 27%, 10%, and 4% of pts entered 2L, 3L, and 4L treatments respectively, vs 43%, 23%, and 13% in the 〈 65 y group. Progression-free survival was significantly shorter in the ≥85 y age group vs the 75-84 y age group (P=0.003), 65-74 y age group (P 〈 0.001), and 〈 65 y age group (P 〈 0.001; Fig.1). TTP was significantly shorter in the ≥85 y group vs the 〈 65 y group (P=0.020); however, TTP was similar among the 65-74 y, 75-84 y, and ≥85 y cohorts (Fig. 2). Overall survival was significantly shorter in the ≥85 y group vs the 75-84 y, 65-74 y, and 〈 65 y groups (all P 〈 0.001; Fig. 3). The mortality rate was lowest (46%) during first-line treatment (1L) in pts aged ≥85 y (mainly attributed to MM progression) and increased in 2L and 3L (47% and 54%, respectively); a similar trend was observed in the younger age groups. The main cause of death was MM progression (29% in the ≥85 y vs 16% in the 〈 65 y group). Other notable causes of death in the ≥85 y group included cardiac failure (5% vs 2% in 〈 65 y group) and pneumonia (5% vs 1% in 〈 65 y group). Conclusions: In this analysis, elderly pts received similar types of frontline and maintenance regimens as younger pts, although proportions varied with decreased use of triplet regimens with age. Considering similarities in TTP across the 65-74 y, 75-84 y, and ≥85 y cohorts, these real-world data support active treatment and aggressive supportive care of elderly symptomatic pts, including with novel agents. Additionally, further clinical studies specific to elderly patients with MM should be explored. Disclosures 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. Ailawadhi:Janssen: Consultancy, Research Funding; Takeda: Consultancy; Pharmacyclics: Research Funding; Amgen: Consultancy, Research Funding; Celgene: Consultancy; Cellectar: Research Funding. Gasparetto:Celgene: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; Janssen: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; BMS: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed . Jagannath:AbbVie: Consultancy; Merck & Co.: Consultancy; Bristol-Myers Squibb: Consultancy; Karyopharm Therapeutics: Consultancy; Celgene Corporation: Consultancy; Janssen Pharmaceuticals: Consultancy. Rifkin:Celgene: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees. Durie:Amgen, Celgene, Johnson & Johnson, and Takeda: Consultancy. Narang:Celgene: Speakers Bureau. Terebelo:Celgene: Honoraria; Jannsen: Speakers Bureau; Newland Medical Asociates: Employment. Toomey:Celgene: Consultancy. Hardin:Celgene: Membership on an entity's Board of Directors or advisory committees. Wagner:Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; American Cancer Society: Other: Section editor, Cancer journal. Omel:Celgene, Takeda, Janssen: Other: Patient Advisory Committees. Srinivasan:Celgene: Employment, Equity Ownership. Liu:TechData: Consultancy. Dhalla:Celgene: Employment. Agarwal:Celgene Corporation: Employment, Equity Ownership. Abonour:BMS: Consultancy; Celgene: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; Janssen: Consultancy, Research Funding.

Abstract: Introduction: Treatment resistance remains a challenge that most patients (pts) with MM will encounter in their disease course. With each subsequent line of therapy (LOT), pt outcomes and health-related quality of life (HRQoL) worsen. Pts with MM who are refractory to immunomodulatory drugs, proteasome inhibitors (PIs), and anti-CD38 antibodies (triple-class refractory; TCR) have a poor prognosis and the holistic burden is not well understood. To capture these features, the ongoing prospective Connect ® MM Disease Registry was used to report treatment patterns and outcomes in pts with TCR MM. Methods: Data from September 28, 2009 to February 4, 2021 were used. Eligible pts were ≥18 years of age at first documented diagnosis of MM, which became TCR during their disease course. MM was defined as refractory to therapies based on the International Myeloma Working Group Criteria. Index date was defined as first record of TCR during the disease course. Data analyzed included pt characteristics, treatment patterns pre- and post-index, overall survival (OS), healthcare resource utilization (HCRU), and HRQoL. General HRQoL was captured by EQ-5D-3L utility index (range −0.11-1, higher score indicated better HRQoL), EQ-5D visual analog scale (VAS) score (range 0-100, "worst imaginable" to "best imaginable" health status), and FACT-G total score (range 0-108). Disease-specific HRQoL was measured by FACT-MM total score (range 0-164), FACT-MM Trial Outcome Index (TOI) (range 0-112), and the Brief Pain Inventory (BPI) average pain item (range 0-10, "no pain" to "worst pain you can imagine"). Higher scores indicated better HRQoL for all FACT-related index scores. Cohort-level clinically meaningful change in HRQoL during post-index year 1 was defined as 0.08 for the EQ-5D utility index, 7 for the EQ-5D VAS, and 6-8 points for the FACT-G total score. Validated thresholds were unavailable for other index scores. All statistical analyses were descriptive. Results: This analysis included 240 pts identified from the Registry. Mean age at index date was 68.1 (standard deviation [SD] 10.4) years. Mean time from initial MM diagnosis was 64.1 (SD 26.9) months. 63.3% of pts had prior stem cell transplantation. Mean number of prior LOTs was 4 (SD 1.7). 64.6% of pts had received a subsequent MM LOT since index date. Median follow-up time post-index date was 4.6 months. Treatment pattern analysis of post-index treated pts (Table A) revealed that retreatment with an immunomodulatory drug, PI, or anti-CD38 agent post-index date was common, led by carfilzomib (47.1%) and pomalidomide (40.0%). However, no therapeutic combination was preferred in this pt population. Regarding their index therapy (first post-index LOT), 70.3% and 22.6% were on triplet and quadruplet combination therapy; 3.2% initiated belantamab mafodotin, selinexor, melflufen, and/or idecabtagene vicleucel; mean duration of treatment was 5.6 (SD 6.1) months. For all pts, median OS was 8.9 months; median OS for those who received & lt; 4 prior LOTs (43.8%) versus those who received 4 or more prior LOTs (56.2%) was 10.0 and 8.0 months, respectively. Regarding HCRU during the post-index follow-up, all-cause and MM-related hospitalizations were observed in 49.6% and 23.8% of all eligible pts, respectively. Among these pts, annualized mean number of all-cause/MM-related hospitalization and length of hospital stay were estimated as 8.5 (SD 18.2)/11.0 (SD 25.2) and 64.0 days (SD 80.0)/ 69.2 days (SD 83.7), respectively. Analysis of HRQoL showed a numerical decline in HRQoL relative to index during the 1-year post-index period across all studied HRQoL instruments. There was a clinically meaningful decline in HRQoL from baseline following the index date based on the EQ-5D utility index, EQ-5D VAS, and FACT-G total score (Table B). Conclusion: Pts with TCR MM experienced poor survival, substantial hospitalizations, and a clinically meaningful decline in HRQoL. 35.4% of pts did not receive any new LOTs since the disease became TCR. Among those who did receive subsequent LOTs, re-treatment with an immunomodulatory drug, PI, or anti-CD38 antibody therapy occurred, showing a lack of novel treatment options. This study suggests novel tolerable and efficacious therapeutic agents are needed to address the burden of illness in pts with MM. Figure 1 Figure 1. Disclosures Tang: Bristol-Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Hari: Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other, Research Funding, Speakers Bureau; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other, Research Funding, Speakers Bureau; Celgene-BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other, Research Funding, Speakers Bureau; Adaptive Biotech: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Oncopeptides: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Karyopharm: Consultancy; GSK: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other, Research Funding, Speakers Bureau; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other, Research Funding, Speakers Bureau; Millenium: Membership on an entity's Board of Directors or advisory committees, Research Funding. Ramasamy: Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees; Adaptive Biotechnologies: Honoraria, Membership on an entity's Board of Directors or advisory committees; GSK: Honoraria, Membership on an entity's Board of Directors or advisory committees; Oncopeptides: Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene - Bristol Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Weisel: Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Oncopeptides: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Adaptive Biotechnologies: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; GSK: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Karyopharm: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Abbvie: Consultancy; Novartis: Honoraria; Pfizer: Honoraria. Joshi: Bristol Myers Squibb: Current Employment. Liu: Bristol Myers Squibb: Current Employment. Che: Bristol Myers Squibb: Current Employment. Hernandez: Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Abonour: Jensen: Honoraria, Research Funding; Celgene-BMS: Membership on an entity's Board of Directors or advisory committees, Research Funding; GSK: Consultancy, Honoraria, Research Funding; Takeda: Research Funding. Hardin: Bristol Myers Squibb: Membership on an entity's Board of Directors or advisory committees. Rifkin: Sanofi: Membership on an entity's Board of Directors or advisory committees; McKesson: Current Employment, Current equity holder in publicly-traded company; Karyopharm: Membership on an entity's Board of Directors or advisory committees; Fresenius-Kabi: Membership on an entity's Board of Directors or advisory committees; Coherus: Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb (Celgene): Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees. Ailawadhi: BeiGene, Ltd.: Consultancy; Bristol Myers Squibb: Consultancy, Research Funding; Janssen: Consultancy, Research Funding; Amgen: Consultancy, Research Funding; Pharmacyclics: Consultancy, Research Funding; Ascentage: Research Funding; Medimmune: Research Funding; Cellectar: Research Funding; Xencor: Research Funding; GSK: Consultancy, Research Funding; Takeda: Consultancy; Genentech: Consultancy; AbbVie: Consultancy; Karyopharm: Consultancy; Sanofi: Consultancy; Oncopeptides: Consultancy. Lee: Legend Biotech: Consultancy; Sanofi: Consultancy; Oncopetides: Consultancy; Bristol Myers Squibb: Consultancy; Amgen: Consultancy, Research Funding; Celgene: Consultancy; Janssen: Consultancy, Research Funding; Takeda Pharmaceuticals: Consultancy, Research Funding; Karyopharm: Consultancy; Regeneron: Research Funding; Genentech: Consultancy; GlaxoSmithKline: Consultancy, Research Funding. Terebelo: Pharmacylics: Speakers Bureau; Celgene-BMS: Consultancy; Takeda: Speakers Bureau; Janssen: Speakers Bureau. Durie: Amgen, Celgene/Bristol-Myers Squibb, Janssen, and Takeda: Consultancy; Amgen: Other: fees from non-CME/CE services . Narang: Bristol Myers Squibb: Consultancy; TG Pharma: Consultancy. Toomey: Bristol Myers Squibb: Consultancy. Gasparetto: Oncopeptide: Consultancy, Honoraria, Speakers Bureau; Janssen: Consultancy; Sanofi: Consultancy, Honoraria, Speakers Bureau; Karyopharm: Consultancy, Honoraria, Speakers Bureau; Gsk: Consultancy, Honoraria, Speakers Bureau. Wagner: Celgene-BMS: Consultancy, Membership on an entity's Board of Directors or advisory committees; Athenex Inc: Consultancy; Eli Lilly, Johnson & Johnson: Other: Spouse, previously held individual stocks;. Jagannath: Janssen Pharmaceuticals: Consultancy; Bristol Myers Squibb: Consultancy; Karyopharm Therapeutics: Consultancy; Legend Biotech: Consultancy; Sanofi: Consultancy; Takeda: Consultancy.

Abstract: Abstract 5032 Background: In the past decade, with the availability of novel therapies, the paradigm for myeloma management has changed. In 2010 it is especially important to understand baseline features and initial treatment decisions. The goal of the Connect MM® registry is to characterize patients with newly diagnosed active myeloma from 200 US sites. Approximately 80% of the patient population will be enrolled from community-based practices and 20% from academic centers. An electronic case report form was developed to collect clinical data, physician choices, patient health-related quality of life (HRQoL) and response, as well as data on survival end points. This is a prospective, observational, longitudinal study with a target accrual of 1,500 patients in 3 years, with a 5 year follow-up from the time of informed consent. There are no mandated treatments or clinical assessments. However, there are data collection requirements for diagnosis and disease monitoring. Results: Since late 2009, 340 patients from 135 sites have been accrued and were included in this interim analysis. Current study demographics include: 60% male, 83% white, and 14% black, with a median age of 67 years. Thus far, 97% have been enrolled from community-based practices. All patients met study enrollment criteria and had active myeloma at entry; prior monoclonal gammopathy of unknown significance (MGUS) was reported in 13% and smoldering MM in 8%. International Staging System (ISS) staging for evaluable patients were 26.3%, 36.4%, 37.3% for stages I, II, and III, respectively. Durie-Salmon Stage (A or B) were 13%, 35%, 52% for stages I, II, and III, respectively. Staging procedures included 82% skeletal survey; 44% computed tomography (CT); 40% magnetic resonance imaging (MRI); 7% positron emission tomography (PET); 2% PET/CT; and 4% had no imaging. International Myeloma Working Group (IMWG) CRAB criteria were assessed in all enrolled patients; 9% had hypercalcemia, 18% renal insufficiency, 36% anemia, and 66% had bone lesions. Median values were: calcium 9.5 mg/dL; serum creatinine 1.1 mg/dL; hemoglobin 10.9 gm/dL. Only 9% of patients had 3 or 4 CRAB features, while 49% had only 1 feature and 26% were asymptomatic (ECOG=0). The incidence of baseline peripheral neuropathy was 6%. Initial pain led to radiation therapy for 10% of patients, with 16% having vertebroplasty or kyphoplasty. Cytogenetic studies were performed at baseline in 64% of patients and fluorescence in situ hybridization (FISH) studies in 54%. Cytogenetics and FISH were normal in 27% of patients, while in 20% both were abnormal in patients who had both performed. FISH was abnormal with normal cytogenetics in 41% and only 2% had normal FISH but abnormal cytogenetics. The most common FISH abnormalities were: 13 q- (31%), 17 p- (28%), t(4; 14) (16%). Freelite® testing was performed in 56% of patients with an abnormal ratio in 94% [rFLC]. Of evaluable patients receiving frontline therapy 98% of patients received a novel agent and only 3 patients (1.4% of treated patients) received melphalan/prednisone. Two drug combinations were used in 53%, 3 drugs in 26%, 4 drugs in 1.3%, and single agents were used in 21% of the patients. The most common regimens were: bortezomib+dexamethasone (28%), lenalidomide+dexamethasone (20%), and bortezomib+lenalidomide+ dexamethasone (15%). Conclusion: These baseline features and treatment choices characterize myeloma patients primarily in community-based practices in the US in 2010. As academic centers enroll more patients, we will be able to further characterize that population. Of particular note, 26% of patients were asymptomatic at baseline but had biochemical evidence of myeloma and met enrollment criteria; conversely 95% had an abnormal rFLC and 73% had abnormal chromosome results. The Connect MM® registry will provide data regarding patient features as they pertain to patterns in testing and treatment in the clinical practice setting, as well as response and survival outcomes. Disclosures: Durie: Celgene & Millennium: Consultancy. Off Label Use: Revlimid (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy. Shah:Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Millennium: Research Funding; Novartis: Research Funding. Abonour:Celgene & Millennium: Honoraria. Gasperetto:Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Millennium: Speakers Bureau. Mehta:Celgene: Consultancy, Speakers Bureau; Takeda/Millennium: Speakers Bureau; Onyx: Research Funding. Pashos:Celgene Corporation: Membership on an entity's Board of Directors or advisory committees, Research Funding. Toomey:Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees. Swern:Celgene: Employment. Street:Celgene: Employment. Sullivan:Celgene: Employment, Equity Ownership. Rifkin:Millennium: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Speakers Bureau; Amgen: Speakers Bureau; Cephalon: Speakers Bureau; Dendreon: Speakers Bureau.

Abstract: Introduction: Phase 3 trials demonstrated maintenance therapy after autologous stem cell transplant (ASCT) extended time to progression, progression-free survival, and in some cases overall survival for patients (pts) with multiple myeloma (MM) (Sonneveld, 2012; McCarthy, 2012; Attal, 2012; Palumbo, 2014; Attal, 2016). Maintenance treatment until progression has the potential to adversely impact health-related quality of life (HRQoL). Few HRQoL analyses have been published in MM, especially with regard to maintenance therapy after ASCT. Connect® MM is the first and largest multicenter, US-based, prospective observational cohort study designed to characterize treatment patterns and outcomes for pts with newly diagnosed MM (NDMM). This analysis evaluated HRQoL of pts who received Any maintenance therapy, lenalidomide (LEN) only, or No maintenance post-ASCT. Methods: Pts ≥ 18 years with NDMM within 60 days of diagnosis were eligible for enrollment in the registry. For this analysis, pts who completed induction therapy and first-line ASCT who may or may not have gone on to receive maintenance (yes/no) were included. Pts were evaluated in 3 groups: Any maintenance (including LEN-only), LEN-only maintenance, and No maintenance. Pt-reported HRQoL data were collected at protocol-defined quarterly visits. The primary HRQoL measure analyzed was the EQ-5D Index score. Secondary measures included the Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) total score and the Brief Pain Inventory (BPI). HRQoL assessments were analyzed at study entry (study baseline); after induction therapy but prior to ASCT (analytic baseline); and quarterly from 100 days post-ASCT until the end of maintenance (maintenance groups) or until progressive disease, discontinuation, or death (all groups) (analytic period). SAS Proc Mixed with a random effects unstructured covariance matrix was used to estimate mixed regression models to test the null hypothesis of no HRQoL difference between pts receiving Any or LEN-only maintenance vs No maintenance. A quadratic growth model was used with time as a continuous variable (given that ASCT can occur at any fractional quarterly period post-enrollment and having a starting at 100 days post-ASCT), adjusted for potential confounders. Results: Between September 2009 and December 2011, Connect® MM enrolled 1493 pts in Cohort 1 from community (82%) and academic (17%) centers. Of the 540 pts who received ASCT, 238 met the analysis criteria for Any maintenance, 167 for LEN-only, and 138 for No maintenance. Median age (range) was 60 years (24-78); 61% were male, and 85% were white. The majority were Eastern Cooperative Oncology Group performance status 0/1 (64%) and International Staging System stage I/II (56%). A higher proportion of pts in the Any and LEN-only maintenance groups received triplet therapy as induction vs the No maintenance group (64%, 66%, and 51%, respectively). Median duration (range) of maintenance in the Any and LEN-only maintenance groups was 23.0 months (0.8-50.4) and 24.4 months (0.6-50.4), respectively. During the analytic period, the EQ-5D questionnaire completion rate across the 3 comparison groups was similar and decreased at a similar rate over time. The median number (range) of EQ-5D forms completed per patient was 4.5 (1.0-16.0), 5.0 (1.0-15) and 5.0 (1.0-16.0) for Any, LEN-only, and No maintenance groups, respectively. The mean baseline HRQoL scores for each measure were similar across the 3 groups, with ranges of EQ-5D (0.75-0.76), FACT-MM Total (114.8-119.7), and BPI (3.87-4.06). There were no significant differences in estimated mean post-ASCT scores when comparing Any or LEN-only with the No maintenance group for the EQ-5D Overall Index, the FACT-MM Total Score, or the BPI (Table and Figure). Conclusions: NDMM pts in the Connect® MM registry receiving Any or LEN-only maintenance therapy vs No maintenance after ASCT demonstrated generally similar HRQoL scores for the EQ-5D Index, FACT-MM, and BPI. These results suggest that there is no difference in HRQoL for those who received maintenance compared with those who did not despite the risks associated with continued active therapy. Save Disclosures Abonour: Celgene: Membership on an entity's Board of Directors or advisory committees. Jagannath:Bristol-Myers Squibb: Consultancy; Celgene: Consultancy; Merck: Consultancy. Terebelo:Celgene: Membership on an entity's Board of Directors or advisory committees. Gasparetto:Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Consultancy; Bristol-Myers Squibb: Honoraria; Onyx: Honoraria; Janssen: Honoraria. Toomey:Celgene: Consultancy. Hardin:Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees. Kitali:Celgene: Employment, Equity Ownership. Gibson:Celgene: Employment, Equity Ownership; Sanofi: Other: Spouse employment . Srinivasan:Celgene: Employment; Individual Patent: Patents & Royalties: US7,495,673B1 Used for MM-Connect Treatment Patterns Abstract.. Swern:Celgene: Employment, Equity Ownership. Rifkin:Celgene: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Amgen/ONYX: Membership on an entity's Board of Directors or advisory committees.