Publications by authors named "Ailawadhi S"

Background: This analysis explored real-world characteristics, treatment patterns and clinical outcomes in patients with relapsed or refractory multiple myeloma (RRMM) previously treated with lenalidomide and an anti-CD38 monoclonal antibody (mAb) and requiring subsequent treatment.

Materials And Methods: The PREAMBLE and Connect MM prospective registries of patients with multiple myeloma (MM), and the US nationwide Flatiron Health electronic health record-derived de-identified database were analysed. MM-specific treatment patterns (prior/index therapies) and outcomes (progression-free survival [PFS]/overall survival [OS]) were assessed.

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Multiple myeloma (MM) is a complex hematological malignancy of clonal plasma cells driven by alterations to the chromosomal material leading to uncontrolled proliferation in the bone marrow. Ethnic and racial disparities persist in the prevalence, diagnosis, management, and outcomes of MM. These disparities are multifaceted and intersect with various factors, including demographics, geography, socioeconomic status, genetics, and access to healthcare.

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Purpose: Teclistamab is initiated with a step-up dosing (SUD) schedule to mitigate the risk of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Early teclistamab users commonly received SUD in a hospital setting. This study aimed to evaluate safety and health care resource utilization (HRU) in real-world patients with multiple myeloma who initiated teclistamab SUD in an outpatient setting.

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Background: Available treatments for relapsed/refractory multiple myeloma (RRMM) include multiclass triplet regimens such as lenalidomide and dexamethasone (Rd backbone) plus ixazomib (proteasome inhibitor [PI]; I) or daratumumab (monoclonal antibody; D). Although prior real-world studies compared PI-Rd triplets, this research extends those findings by comparing health care costs of a PI-based and a monoclonal antibody-based triplet, IRd and DRd, in patients with RRMM in the United States.

Objective: To describe and compare all-cause and MM-related health care costs in patients with RRMM treated with IRd vs DRd.

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Background: Over the last 15 years, improvements in patient management and treatments have been associated with longer survival in patients with multiple myeloma (MM). The Connect MM Registry is a long-running, US, multicenter, prospective observational cohort study of patients with newly diagnosed MM (NDMM). We assessed the demographics, clinical characteristics, and treatment patterns of long-term survivors (LTS) enrolled in this registry.

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Limited data exist on the effects of induction treatment in patients with newly diagnosed multiple myeloma (NDMM) and renal impairment (RI), who may also be ineligible for autologous stem cell transplant. This analysis investigated the impact of lenalidomide-bortezomib-dexamethasone (RVd) induction on renal function in patients from the Connect® MM Registry based on transplant status. Eligible patients were aged ≥18 years with symptomatic MM diagnosed ≤2 months before enrollment.

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Article Synopsis
  • - MEDI2228 is an antibody drug conjugate designed to target B-cell maturation antigen (BCMA) and was tested in a phase 1 trial for patients with relapsed/refractory multiple myeloma after prior treatments with standard medications.
  • - The trial involved 107 patients, identifying a maximum tolerated dose of 0.14 mg/kg every three weeks, with common side effects including photophobia, rash, and thrombocytopenia; two patients experienced serious dose-limiting toxicities.
  • - Although MEDI2228 showed promising efficacy with a 56.1% objective response rate in one treatment group, ocular toxicity issues led to the decision not to pursue further development of the drug.
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  • * A study involving 541 patients found that reducing dexamethasone doses (LD-DEX) didn’t significantly affect progression-free survival (PFS) or overall survival (OS) compared to full doses (FD-DEX).
  • * The findings indicate that dose reductions are frequently made during treatment, but their impact on patient outcomes in modern treatment protocols needs more investigation.
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Importance: Utilization of hematopoietic cell transplantation (HCT) for hematologic cancers previously demonstrated race, ethnicity, and age-based disparities.

Objective: To evaluate utilization over time by race, ethnicity, and age to determine if disparities persist in light of recent significant increases in HCT volume.

Design, Setting, And Participants: This US population-based retrospective cohort study includes patients who received transplants from January 2009 to December 2018.

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Outcomes are poor in triple-class-exposed (TCE) relapsed and refractory multiple myeloma (R/RMM). In the phase 3 KarMMa-3 trial, patients with TCE R/RMM and 2 to 4 prior regimens were randomized 2:1 to idecabtagene vicleucel (ide-cel) or standard regimens (SRs). An interim analysis (IA) demonstrated significantly longer median progression-free survival (PFS; primary end point; 13.

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  • Many patients with multiple myeloma in the U.S. face unfair treatment differences based on race, income, and where they live, especially when their cancer comes back.
  • There are new treatment options available, but some patients can’t get the right care due to problems like access and costs.
  • To fix these issues, experts suggest working closely with local doctors, better understanding patients' lives, and making sure everyone can access new treatments fairly.
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  • There are three main types of BCMA-directed therapy for myeloma: antibody drug-conjugates (ADCs), CAR-T, and T-cell engagers (TCEs), each offering unique benefits and challenges.
  • A study at Mayo Clinic examined 339 myeloma patients treated with various BDTs from 2018 to 2023, finding that CAR-T and TCEs provided significantly better progression-free and overall survival compared to ADCs.
  • Results indicated that while CAR-T is the most effective option, patients with previous BDT experiences or aggressive disease may benefit more from other treatment strategies.
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Background: Lenalidomide (R), bortezomib (V), and dexamethasone (d) is a standard-of-care regimen in newly diagnosed multiple myeloma (NDMM); however, characteristics and outcomes for nontransplanted patients receiving frontline RVd are not well understood.

Patients: The Connect MM Registry is a large, US, multicenter, prospective observational cohort study of NDMM patients.

Methods: This analysis investigated characteristics and outcomes of patients who received RVd alone or followed by Rd or R (RVd ± Rd/R) who did not undergo frontline autologous stem cell transplantation.

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Currently, the role of DNA methylation in the immunoglobulin M (IgM) monoclonal gammopathy disease spectrum remains poorly understood. In the present study, a multiomics prospective analysis was conducted integrating DNA methylation, RNA sequencing (RNA-seq), and whole-exome sequencing data in 34 subjects (23 with Waldenström macroglobulinemia [WM], 6 with IgM monoclonal gammopathy of undetermined significance [MGUS], and 5 normal controls). Analysis was focused on defining differences between IgM gammopathies (WM/IgM-MGUS) compared with controls, and specifically between WM and IgM-MGUS.

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Multiple myeloma (MM) therapeutics have evolved tremendously in recent years, with significant improvement in patient outcomes. As newer treatment options are developed, stem cell transplant (SCT) remains an important modality that provides excellent disease control and delays the progression of disease. Over the years, SCT use has increased overall in the U.

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  • The study focuses on the prognosis of patients with Waldenström macroglobulinemia (WM) and reassesses traditional prognostic scoring systems in light of new therapies and genetic data.
  • Researchers analyzed records of 889 treatment-naïve WM patients to identify clinical predictors influencing overall survival, leading to a new prognostic model based on factors like age and serum levels.
  • The newly developed Modified Staging System for WM (MSS-WM) successfully categorizes patients into four distinct risk groups based on their clinical data, demonstrating significant differences in 5-year overall survival rates.
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  • There has been an increase in the number of hematopoietic cell transplants (HCT) and improvement in overall survival after these procedures for blood disorders, but the impact on racial/ethnic minorities is unclear.
  • A study examined transplant rates and survival trends among non-Hispanic Whites, non-Hispanic African Americans, and Hispanics from 2009 to 2018, revealing that Hispanics and non-Hispanic African Americans experienced higher rates of transplant than non-Hispanic Whites.
  • Despite overall improvements in survival rates across groups, non-Hispanic African Americans faced greater mortality risks after allogeneic transplants, indicating ongoing disparities that need to be addressed.
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Patients with relapsed/refractory multiple myeloma (RRMM) that are refractory to the five most active anti-MM drugs, so-called penta-refractory MM, have historically had dismal outcomes with subsequent therapies. Progressive immune dysfunction, particularly of the T-cell repertoire, is implicated in the development of disease progression and refractory disease. However, the advent of novel immunotherapies such as bispecific antibodies are rapidly changing the treatment landscape and improving the survival outcomes of patients with RRMM.

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Background: This retrospective longitudinal study compared the effectiveness of dexamethasone+lenalidomide (Rd)-based triplet regimens containing proteasome inhibitors (PIs) ixazomib (IRd), carfilzomib (KRd), and bortezomib (VRd) or monoclonal antibodies (MABs) elotuzumab (ERd) and daratumumab (DRd) in patients with relapsed/refractory multiple myeloma (RRMM)-including those with high cytogenetic risk-primarily treated at community oncology clinics in the United States.

Methods: Electronic health records of adult RRMM patients in a deidentified real-world database (01/01/2014-09/30/2020) who initiated IRd, KRd, VRd, ERd, or DRd in the second or later line of therapy (LOT) were analyzed. The index date was the date of initiation of each LOT and baseline was the 6-month pre-index period.

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  • Isatuximab-based combinations are now standard care for treating relapsed/refractory multiple myeloma (RRMM), showing positive results in key clinical trials like ICARIA-MM and IKEMA.
  • New studies indicate that Isatuximab (Isa) is also beneficial for newly diagnosed multiple myeloma, expanding its use beyond just RRMM.
  • Innovative administration methods, such as subcutaneous (SC) injections and rapid intravenous (IV) infusions, have been shown to be safe, effective, and more convenient for patients, leading to a preference for SC delivery in future treatments.
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Multi-agent regimens incorporating immunomodulatory (IMiD) agents such as thalidomide, lenalidomide, and pomalidomide have become the preferred standard of care for the treatment of patients with multiple myeloma (MM), resulting in improved survival outcomes. Currently, there are three IMiD agents approved for the treatment of MM: thalidomide, lenalidomide, and pomalidomide. Lenalidomide is commonly used to treat patients with newly diagnosed MM and as maintenance therapy following stem cell transplant or after disease relapse.

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Background: Chimeric antigen receptor T-cell therapy idecabtagene vicleucel (ide-cel) showed significantly improved progression-free survival compared with standard regimens in adults with relapsed and refractory multiple myeloma who had received two to four previous regimens in the ongoing phase 3 KarMMa-3 trial (NCT03651128). This study analysed patient-reported outcomes (PROs), a KarMMa-3 secondary endpoint.

Methods: In the randomised, open-label, phase 3 KarMMa-3 trial, 386 patients in hospitals (≥18 years of age, with measurable disease and an Eastern Cooperative Oncology Group performance status score of 0 or 1, who had received two to four previous regimens-including an immunomodulatory agent, a proteasome inhibitor, and daratumumab-and had documented disease progression after receiving their last dose of the last therapy) were randomly assigned to ide-cel (n=254) or standard regimens (daratumumab, pomalidomide, and dexamethasone; daratumumab, bortezomib, and dexamethasone; ixazomib, lenalidomide, and dexamethasone; carfilzomib and dexamethasone; or elotuzumab, pomalidomide, and dexamethasone; n=132).

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