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Real-World Use of 3rd Line Therapy for Multiple Myeloma in Austria: An Austrian Myeloma Registry (AMR) Analysis of the Therapeutic Landscape and Clinical Outcomes prior to the Use of Next Generation Myeloma Therapeutics.

ObjectiveClinical trials demonstrate improving survival in patients with multiple myeloma (MM) after treatment. However, it is unclear whether increased survival translates to a similar benefit in a real world setting.MethodsWe analyzed the overall survival of 347 multiple myeloma patients in Austria by means of a national registry (AMR), focused on results from 3rd and later lines of therapy. This benchmark was chosen to define a baseline prior to the broad application of upcoming 2nd generation drugs (carfilzomib, pomalidomide).ResultsProjected 10 years survival for patients with MM in Austr

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… Third line therapies were monotherapies in 18%, doublets in 43%, triplets in 36% and other combinations in 3% of cases. 4 th line and later therapies were monotherapies in 24%, doublets in 56%, triplets in 13% and other combinations in 7% of cases. … Treatments applied in the AMR setting in the 3 rd and 4 th line plus setting where dominated by combination regimes with a more intensive pattern in 3 rd line (more triplets) than in 4 th line were therapeutics were mostly used as palliative care. …

The changing landscape of relapsed and/or refractory multiple myeloma (MM): fundamentals and controversies.

The increase in the number of therapeutic alternatives for both newly diagnosed and relapsed/refractory multiple myeloma (RRMM) patients has widened the clinical scenario, leading to a level of complexity that no algorithm has been able to cover up to date. At present, this complexity increases due to the wide variety of clinical situations found in MM patients before they reach the status of relapsed/refractory disease. These different backgrounds may include primary refractoriness, early relapse after completion of first-line therapy with latest-generation agents, or very late relapse after

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… This is compounded by the fact that this population has been excluded from phase 3 RCTs evaluating lenalidomide-combinations, so the use of a lenalidomide-free triplet is also a better option in these patients. … New triplets including MoAbs have not achieved median PFS, but considering their long follow-up (≥17 months), outcomes are expected to be promising [ 50 , 51 , 156 ]. …

A Rare Case of Oligosecretory Multiple Myeloma With Intracranial Plasmacytoma.

Multiple myeloma (MM) is a hematologic malignancy characterized by monoclonal plasma cell proliferation within the bone marrow. According to current International Myeloma Working Group (IMWG) criteria, true non-secretory multiple myeloma (NSMM) is defined by the absence of detectable monoclonal protein even on serum free light chain (FLC) assay, unlike oligosecretory multiple myeloma (OSMM), in which electrophoresis and immunofixation are negative but the FLC κ/λ ratio is pathological - making diagnosis particularly challenging by conventional techniques. The association of OSMM with an intrac

Management of Multiple Myeloma: A Review for General Practitioners in Oncology.

Multiple myeloma (MM) is a malignant clonal plasma cell disorder in the bone marrow and is the second-most common hematologic malignancy in adults. Although patients with MM have a moderate life expectancy, it remains a heterogeneous disease that often requires multiple lines of chemotherapy for durable control and long-term survival. This review outlines current management strategies for both transplant-eligible and transplant-ineligible patients as well as for relapsed and refractory disease. Advances in drug therapies have widened management options and improved survival. In this paper, we

Management of Relapsed-Refractory Multiple Myeloma in the Era of Advanced Therapies: Evidence-Based Recommendations for Routine Clinical Practice.

Multiple myeloma (MM) is the second most common hematologic malignancy in adults worldwide. Over the past few years, major therapeutic advances have improved progression-free and overall survival, as well as quality of life. Despite this recent progress, MM remains incurable in the vast majority of cases. Patients eventually relapse and become refractory to multiple drug classes, making long-term management challenging. In this review, we will focus on the treatment paradigm of relapsed/refractory MM (RRMM) in the era of advanced therapies emphasizing the available novel modalities that have r

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… To date, BTZ is commonly used in triplets with next-generation IMiDs or monoclonal antibodies plus steroids, and sometimes cyclophosphamide ( Table 1 ) [ 13 ]. … Table 1 highlights the major phase II and III clinical trials of triplet combinations including a PI, an IMiD and steroids in the relapsed/refractory setting. …

A brief clinical genetics review: stepwise diagnostic processes of a monogenic disorder-hypertriglyceridemia.

The completion of the Human Genome Project and tremendous advances in automated high-throughput genetic analysis technologies have enabled explosive progress in the field of genetics, which resulted in countless discoveries of novel genes and pathways. Many phenotype- or disease-associated single nucleotide polymorphisms (SNPs) with a high statistical significance have been identified through numerous genome-wide association studies (GWAS), and various polygenic risk scoring (PRS) schemes have been proposed to identify individuals with a high risk for a certain trait or disorder. Meanwhile, me

Toxicity management strategies for next-generation novel therapeutics in multiple myeloma.

The therapeutic options available for patients with multiple myeloma have greatly expanded over the past decade and incorporating these novel agents into routine clinical practice has significantly improved outcomes. The next generation of therapeutics is available for relapsed and refractory patients either as standard of care or in clinical trial, and these drugs represent a generational paradigm shift. Patients now have access to a multitude of novel immunotherapeutics, including monoclonal antibodies, an antibody-drug conjugate, chimeric antigen receptor T-cells (CAR-T), and bispecific T-c

Multiple Myeloma: Clinical Updates from the American Society of Clinical Oncology Annual Scientific Symposium 2020.

The novel clinical data for plasma cell neoplasms (smoldering myeloma, multiple myeloma, and AL amyloidosis) that were presented in the 2020 American Society of Clinical Oncology virtual scientific symposium are summarized here. Data from large phase-3 studies (CASSIOPEIA, ENDURANCE, and TOURMALINE-MM4 trials) and phase-2 studies (SWOG 1211, GMMG CONCEPT trials) for newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplantation are described. Updates from previous important studies for multiple myeloma (STaMINA) along with studies on three different chimeri

Carfilzomib with immunomodulatory drugs for the treatment of newly diagnosed multiple myeloma.

Carfilzomib, a selective proteasome inhibitor (PI), is approved for the treatment of patients with relapsed or refractory multiple myeloma (MM). Combination regimens incorporating a PI and immunomodulatory drug (IMiD) have been associated with deep responses and extended survival in patients with newly diagnosed MM (NDMM). Carfilzomib-based combinations with immunomodulators are being extensively studied in the frontline setting. The objective of this review was to describe efficacy and safety data for carfilzomib-based, PI/immunomodulatory combinations in NDMM. Information sources were articl

Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse.

Multiple myeloma remains an incurable disease with the usual disease course requiring induction therapy, autologous stem cell transplantation for eligible patients, and long-term maintenance. Risk stratification tools and cytogenetic alterations help inform individualized therapeutic choices for patients in hopes of achieving long-term remissions with preserved quality of life. Unfortunately, relapses occur at different stages of the course of the disease owing to the biological heterogeneity of the disease. Addressing relapse can be complex and challenging as there are both therapy- and patie

Delayed diagnosis resulting in increased disease burden in multiple myeloma: the legacy of the COVID-19 pandemic.

The COVID-19 pandemic has had global healthcare impacts, including high mortality from SARS-CoV-2 infection in cancer patients; individuals with multiple myeloma (MM) are especially susceptible to poor outcomes. However, even for MM patients who avoided severe infection, the ramifications of the pandemic have been considerable. The consequences of necessary socio-geographical behavior adaptation, including prolonged shielding and interruptions in delivery of non-pandemic medical services are yet to be fully understood. Using a real-world dataset of 323 consecutive newly diagnosed MM patients i

Pulsed-dose-rate peri-operative brachytherapy as an interstitial boost in organ-sparing treatment of breast cancer.

PURPOSE: To evaluate peri-operative multicatheter interstitial pulsed-dose-rate brachytherapy (PDR-BT) with an intra-operative catheter placement to boost the tumor excision site in breast cancer patients treated conservatively. MATERIAL AND METHODS: Between May 2002 and October 2008, 96 consecutive T1-3N0-2M0 breast cancer patients underwent breast-conserving therapy (BCT) including peri-operative PDR-BT boost, followed by whole breast external beam radiotherapy (WBRT). The BT dose of 15 Gy (1 Gy/pulse/h) was given on the following day after surgery. RESULTS: No increased bleeding or delaye

Autologous Stem Cell Collection after Daratumumab, Bortezomib, Thalidomide, and Dexamethasone versus Bortezomib, Cyclophosphamide, and Dexamethasone in Newly Diagnosed Multiple Myeloma.

IntroductionIn transplant-eligible, newly diagnosed multiple myeloma (NDMM) patients, autologous peripheral blood stem cell (PBSC) collection is usually pursued after induction therapy. While induction regimens are constantly refined regarding response, their impact on PBSC collection is not fully studied. The inclusion of the anti-CD38 antibody daratumumab into induction therapy significantly improved outcomes for patients with NDMM, e.g., as part of the daratumumab, bortezomib, thalidomide, and dexamethasone (Dara-VTD) protocol. Preliminary data from the phase 3 CASSIOPEIA study proved the e

A Cost Impact Analysis of clonoSEQ® as a Valid and CE-Certified Minimal Residual Disease (MRD) Diagnostic Compared to No MRD Testing in Multiple Myeloma in Germany.

IntroductionThe measurement of minimal residual disease (MRD) with clonoSEQ® can be used in the assessment of B-cell lymphoid tumor burden throughout treatment with accuracy, sensitivity and standardization when compared to traditional cytomorphology. With the approval of novel treatments, standardized MRD assessment with improved performance is increasingly important. The aim of this analysis is to estimate the cost-effectiveness of MRD testing with clonoSEQ® compared to no MRD testing for patients with multiple myeloma (MM) on maintenance therapy in Germany.MethodsThe cost impact of clonoSEQ

Selinexor, daratumumab, and dexamethasone in patients with relapsed or refractory multiple myeloma.

We assessed the safety, efficacy, maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D) of selinexor, a first in class oral selective inhibitor of nuclear export (100 mg once weekly [QW] or 60 mg twice weekly), in combination with daratumumab (16 mg/kg per label) and dexamethasone (40 mg QW) (SDd) in patients with relapsed refractory multiple myeloma (RRMM). Thirty-four patients (median prior therapies, 3 [range, 2-10]) were enrolled; MM was refractory to proteasome inhibitor (PI) in 85%, immunomodulatory agent (IMiD) in 76%, both in 74%, and daratumumab in 6% of patients. Two

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… Currently, combining these and other agents as triplets is standard practice based on evidence from clinical trials showing that triplets can induce deep and prolonged responses [ 1 , 2 , 4 , 5 , 8 ]. However, essentially all patients develop disease refractory to multiple agents. … Another daratumumab triplet, daratumumab, pomalidomide, and dexamethasone (DPd) also demonstrates a safety profile similar to Pd, with the most common AE being neutropenia (overall 79.6%, grade 3 or 4 76.7%), followed by anemia (54.4% and 28.2%, respectively) and thrombocytopenia (41.7% in all grades …

Impact of post-transplantation maintenance therapy on health-related quality of life in patients with multiple myeloma: data from the Connect® MM Registry.

Maintenance therapy after autologous stem cell transplantation (ASCT) is recommended for use in multiple myeloma (MM); however, more data are needed on its impact on health-related quality of life (HRQoL). Presented here is an analysis of HRQoL in a Connect MM registry cohort of patients who received ASCT ± maintenance therapy. The Connect MM Registry is one of the earliest and largest, active, observational, prospective US registry of patients with symptomatic newly diagnosed MM. Patients completed the Functional Assessment of Cancer Therapy-MM (FACT-MM) version 4, EuroQol-5D (EQ-5D) question

DNA Binding, DNA Photocleavage, Molecular Docking Studies and Photo-Induced Effect on Melanoma Cells of 2-Methyl-3-OR Quinazolinone Derivatives.

Thirty 2-methyl-quinazolinone fussed hydroxamic acids (3-OH) and their 3-OEt and 3-OBn derivatives were evaluated for their affinity towards calf-thymus (CT) DNA using UV-vis absorption, viscosity and fluorescence spectroscopy. DNA photocleavage activity was assessed by incubating the compounds with plasmid DNA followed by UV-A and visible light irradiation, which enabled identification of the most potent derivatives active at concentrations of 100 nΜ and 10 μΜ, respectively. Mechanistic studies on the most active compounds indicated the formation of oxygen radical species and a decrease in ef

Changing Management of Hematological Malignancies With COVID-19: Statement and Recommendations of the Lebanese Society of Hematology and Blood Transfusion.

COVID-19 caused by SARS-Cov-2 is a devastating infection in patients with hematological malignancies. In 2018, the Lebanese Society of Hematology and Blood Transfusion (LSHBT) updated the guidelines for the management of hematological malignancies in Lebanon. In 2019, it was followed by a second update. Given the rapidly changing evidence and general situation for COVID-19, the LSHBT established some recommendations and suggestions for the management of the patients with hematological malignancies taking into account the Lebanese condition, economic situation, and the facts that SARS-Cov-2 inf

Bortezomib-based induction, high-dose melphalan and lenalidomide maintenance in myeloma up to 70 years of age.

Intensive upfront therapy in newly-diagnosed multiple myeloma (MM) including induction therapy (IT), high-dose melphalan (MEL200), and autologous blood stem cell transplantation (ASCT) followed by consolidation and/or maintenance is mostly restricted to patients up to 65 years of age. Prospective phase III trial data in the era of novel agents for patients up to 70 years of age are not available. The GMMG-MM5 trial included 601 patients between 18 and 70 years of age, divided in three groups for the present analysis: ≤60 years (S1, n = 353), 61-65 years (S2, n = 107) and 66-70 years (S3, n = 1

Should I stay or should I go (to transplant)? Managing insufficient responses to induction in multiple myeloma.

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