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Daratumumab Versus Control Treatment: A Systematic Review and Meta-analysis Study of Survival Outcomes Among Multiple Myeloma Patients : Survival Outcomes of Multiple Myeloma Treatment with Daratumumab.

BACKGROUND: This meta-analysis aimed to evaluate the efficacy of Daratumumab compared to control treatments in multiple myeloma across subgroups, including relapsed or refractory (RRMM), newly diagnosed transplant-eligible (ND/ESCT), and transplant-ineligible (ND/ISCT) patients. MATERIALS AND METHODS: A comprehensive literature search was conducted across PubMed, Scopus, and Web of Science. Randomized controlled trials and comparative studies evaluating Daratumumab versus control treatments in multiple myeloma patients were included. A random-effects model was employed to calculate pooled eff

Clinical Characteristics, Cytogenetic Risks, and Prognoses of Young Multiple Myeloma Patients in the Era of Novel Therapies.

Background/Objectives: In recent years, there have been significant advances in the understanding and treatment of multiple myeloma (MM). Despite this progress, there is still limited information on the disease in patients aged 50 or younger, including the impact of young age on disease characteristics, treatment, and outcome. Methods: In this retrospective study, we analyzed 68 newly diagnosed MM patients aged ≤ 50 years (y) who had undergone at least one peripheral blood stem cell transplantation (PBSCT). Additionally, we reviewed data published during 2008-2022 and compared these to our coh

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… Induction therapy comprising proteasome inhibitor (PI)-containing triplets, with bortezomib, cyclophosphamide, and dexamethasone (VCD), was administered in 76% of patients, according to DSMM XI study protocol. … Induction therapy in most studies consisted of triplets such as VCD, or bortezomib–lenalidomide–dexamethasone (VRd)/lenalidomide–adriamycin–dexamethasone (RAD), consistent with the DSMM XI and XIV studies [ 17 ] and in line with other centers now using D-VRd according to the PERSEUS study [ 11 ]. …

Efficacy and Safety of Ixazomib Plus Lenalidomide and Dexamethasone Following Injectable PI-Based Therapy in Relapsed/Refractory Multiple Myeloma.

This nationwide, multicenter, open-label, single-arm study evaluated the efficacy and safety of the oral proteasome inhibitor (PI), ixazomib plus lenalidomide (LEN) and dexamethasone (DEX) (IRd) following injectable PI-based therapy for relapsed/refractory multiple myeloma (RRMM). Of 45 patients enrolled, 36 patients received IRd after achieving at least a minor response to 3 cycles of bortezomib or carfilzomib plus LEN + DEX (VRd, n=6; KRd, n=30). At median follow-up of 20.8 months, the 12-month event-free survival rate (primary endpoint) was 49% (90% CI: 35.9-62.0), counting 11 events of pro

Comparison between ixazomib+cyclophosphamide+dexamethasone regimen and ixazomib+dexamethasone regimen for elderly and frail patients having newly diagnosed multiple myeloma.

AIMS: The purpose of this prospective, randomized study was to investigate the effectiveness and safety of the ixazomib+cyclophosphamide+dexamethasone (ICd) and ixazomib+dexamethasone (Id) regimens in newly diagnosed multiple myeloma (NDMM) who were elderly and frail and to compare the two regimens. METHODS: Patients were randomly grouped into ICd and Id group. The primary end point was ORR, and patients who received at least two cycles were analyzed. The median follow-up was 13.5 months. After nine induction cycles, patients were instructed to take single ixazomib for maintenance. RESULTS:

How to Manage Patients with Lenalidomide-Refractory Multiple Myeloma.

Although lenalidomide-based combinations, such as lenalidomide plus a proteasome inhibitor or an anti-CD38 monoclonal antibody, improve the overall response rate, progression-free survival, and overall survival of patients with relapsed/refractory multiple myeloma (RRMM), there is a tendency to use these regimens as a frontline treatment. This strategy has led to the development of refractoriness early in the disease course, usually after the patient's first treatment. Since lenalidomide-free regimens have so far shown limited efficacy in lenalidomide-refractory patients, there is an unmet nee

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… Patients with RRMM not previously treated with lenalidomide may benefit from new highly active lenalidomide-based triplet combinations, such as carfilzomib plus lenalidomide and dexamethasone (KRd) [ 7 ], daratumumab plus lenalidomide and dexamethasone (DaraRd) [ 8 ], ixazomib plus lenalidomide and dexamethasone … Real-world comparative effectiveness of triplets containing bortezomib (B), carfilzomib (C), daratumumab (D), or ixazomib (I) in relapsed/refractory multiple myeloma (RRMM) in the US. Ann. Hematol. 2021;100:2325–2337. doi: 10.1007/s00277-021-04534-8. 20. …

Minimal Residual Disease in Myeloma: Application for Clinical Care and New Drug Registration.

The development of novel agents has transformed the treatment paradigm for multiple myeloma, with minimal residual disease (MRD) negativity now achievable across the entire disease spectrum. Bone marrow-based technologies to assess MRD, including approaches using next-generation flow and next-generation sequencing, have provided real-time clinical tools for the sensitive detection and monitoring of MRD in patients with multiple myeloma. Complementary liquid biopsy-based assays are now quickly progressing with some, such as mass spectrometry methods, being very close to clinical use, while othe

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… designed to ask clinically relevant questions including: defining the ideal duration of maintenance therapy after autologous stem cell transplantation (ASCT); defining whether MRD-directed treatment intensification is beneficial in patients who do not achieve MRD negativity after induction therapy with triplet … Recent trials have focused on development of quadruplets with addition of mAbs to the PI-IMiD triplets. …

Pursuing a Curative Approach in Multiple Myeloma: A Review of New Therapeutic Strategies.

Multiple myeloma (MM) is still considered an incurable hematologic cancer and, in the last decades, the treatment goal has been to obtain a long-lasting disease control. However, the recent availability of new effective drugs has led to unprecedented high-quality responses and prolonged progression-free survival and overall survival. The improvement of response rates has prompted the development of new, very sensitive methods to measure residual disease, even when monoclonal components become undetectable in patients' serum and urine. Several scientific efforts have been made to develop reliab

Chemotherapy for small cell lung cancer: a comprehensive review.

Combination chemotherapy is the current strategy of choice for treatment of small cell lung cancer (SCLC). Platinum containing combination regimens are superior to non-platinum regimens in limited stage-SCLC and possibly also in extensive stage-SCLC as first and second-line treatments. The addition of ifosfamide to platinum containing regimens may improve the outcome but at the price of increased toxicity. Suboptimal doses of chemotherapy result in inferior survival. Early intensified, accelerated and high-dose chemotherapy gave conflicting results and is not considered a standard option outsi

Bendamustine, pomalidomide, and dexamethasone for relapsed and/or refractory multiple myeloma.

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Shaping the Treatment Paradigm Based on the Current Understanding of the Pathobiology of Multiple Myeloma: An Overview.

Multiple myeloma is an incurable malignancy which despite progressive improvements in overall survival over the last decade remains characterised by recurrent relapse with progressively shorter duration of response and treatment-free intervals with each subsequent treatment. Efforts to unravel the complex and heterogeneous genomic alterations, the marked dysregulation of the immune system and the multifarious interplay between malignant plasma cells and those of the tumour microenvironment have not only led to improved understanding of myelomagenesis and disease progression but have facilitate

Belantamab mafodotin плюс венетоклакс в t()11;14)-положительное повторное или повторное несколько миелом – испытание BELI(E)VE

Множественная миелома (ММ) — широко неизлечимая злокачественная клетка B-клеток, которая в основном затрагивает пожилых людей. 10% от рака гематологов. Несмотря на достижения в области терапии, которые значительно увеличили средний показатель общего выживания (ОС), ММ по-прежнему является клинической проблемой с плохим прогнозом в отношении пациентов, отказывающихся от лечения в нескольких классах лекарственных препаратов. Существует острая потребность в новаторских и индивидуализированных методах лечения, в том числе для пациентов с транслокацией (см.11;14), подгруппу, характеризующуюся особо

From toxicity to immunity: Evaluating CAR-T and conventional therapies in multiple myeloma through quality-adjusted life year (QALY) outcomes.

Multiple myeloma (MM) remains characterized by recurrent relapse and cumulative treatment burden despite major therapeutic advances. This study compared conventional stepwise regimens with CAR-T cell therapy in terms of QoL, toxicity, cost, and ethical considerations within a model-based comparative framework. This comparative pharmacoeconomic modeling analysis was based on published clinical trial data. Kaplan-Meier survival curves were digitized to estimate mean overall survival (OS) and progression-free survival (PFS) using area-under-the-curve integration. Treatment costs were calculated b

Perspectives in Melanoma: meeting report from the Melanoma Bridge (December 1st-3rd, 2022-Naples, Italy).

Outcomes for patients with melanoma have improved over the past decade with the clinical development and approval of immunotherapies targeting immune checkpoint receptors such as programmed death-1 (PD-1), programmed death ligand 1 (PD-L1) or cytotoxic T lymphocyte antigen-4 (CTLA-4). Combinations of these checkpoint therapies with other agents are now being explored to improve outcomes and enhance benefit-risk profiles of treatment. Alternative inhibitory receptors have been identified that may be targeted for anti-tumor immune therapy, such as lymphocyte-activation gene-3 (LAG-3), as have se

Diagnosis and management of immune effector cell-associated enterocolitis after ciltacabtagene autoleucel.

AbstractImmune effector cell-associated enterocolitis (IEC-EC) has been observed after ciltacabtagene autoleucel (cilta-cel [Carvykti]) chimeric antigen receptor T-cell (CAR-T) therapy. It is associated with dismal outcomes and is poorly characterized. Here, we examined its clinical features, risk factors, and proposed management strategies. Among the 229 consecutive patients who received cilta-cel at Mayo Clinic, 9 (3.9%) presented with a nonresolving, nonbloody, grade 3 diarrhea, often requiring prolonged total parenteral nutrition. Gastrointestinal coinfections were seen in most patients. M

Руководящие принципы и консенсус в отношении минимально адаптированной к остаточным болезням терапии в множестве миеломы, выработанные Рабочей группой по миеломе в Пантихоокеанском регионе.

Лечение множественной миеломы (ММ) вступило в эру терапии, ориентированной на глубокую ремиссию, где минимальные остаточные заболевания (МВД) стали ключевым показателем реакции на лечение и долгосрочного прогнозирования, превосходя обычные критерии полной ремиссии. Однако оптимальная интеграция МРТ в процесс принятия клинических решений еще не достигнута. Этот экспертный консенсус предлагает основанные на фактических данных руководящие указания относительно пересмотра целей лечения в эпоху лечения на основе CD38, включения статуса MRD в терапевтические решения, стандартизации обнаружения MRD и

Ixazomib, pomalidomide and dexamethasone in triple-class exposed multiple myeloma patients - a phase II study.

Multi-class upfront regimens for multiple myeloma (MM) have improved outcomes, yet many patients become either triple-class exposed (TCE) or refractory (TCR) early in their disease course. This is a phase II, investigator initiated, open-label, single-arm, prospective, multicenter study evaluating all-oral Ixazomib-pomalidomide- dexamethasone (IPd) regimen for TCE RRMM patients. Sixty-one patients were enrolled between March 1st 2021 and March 17th 2024. The median age was 74 (range: 53-89) years; 25 (41%) were ≥75 years old. Fiftyseven percent had high-risk cytogenetics (t(4;14), t(14;16), +1

Modification of belantamab mafodotin dosing to balance efficacy and tolerability in the DREAMM-7 and DREAMM-8 trials.

AbstractBelantamab mafodotin (belamaf) combined with standard therapies demonstrated significant progression-free survival (PFS) and overall survival benefits in DREAMM-7 and PFS benefit in DREAMM-8 in relapsed/refractory multiple myeloma. Belamaf dose modifications managed adverse events, including belamaf-related ocular events. Ocular events included ocular adverse reactions (eg, dry eyes, photophobia, eye irritation) and protocol-mandated ophthalmic examination findings. Protocol-recommended dose modifications for ocular events were driven by ophthalmic examination findings and included bel

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… Discussion Most patients treated with belamaf triplets in the DREAMM-7 and DREAMM-8 trials experienced grade 2 or 3 ocular events that were managed with protocol-recommended dose modifications; therefore, patients could remain on belamaf treatment and derive robust efficacy benefit. … Unlike other B-cell maturation antigen–targeted therapies, including chimeric antigen receptor T cells and bispecific monoclonal antibodies, belamaf triplets do not require administration and monitoring in specialized medical centers, because rates of opportunistic infections were infrequent, and serious …

Progression-free survival as a surrogate endpoint in myeloma clinical trials: an evolving paradigm.

Measurement of overall survival (OS) remains the gold standard for interpreting the impact of new therapies for multiple myeloma in phase 3 trials. However, as outcomes have improved, it is increasingly challenging to use OS as the primary endpoint if timely approval of novel agents is to be ensured to enable maximum benefit for patients. Surrogate endpoints of OS, such as progression-free survival (PFS) and response to treatment, have contributed to approval decisions by the Food and Drug Administration (FDA) and European Medicines Agency as endpoints demonstrating clinical benefit, and the F

ML-based sequential analysis to assist selection between VMP and RD for newly diagnosed multiple myeloma.

Optimal first-line treatment that enables deeper and longer remission is crucially important for newly diagnosed multiple myeloma (NDMM). In this study, we developed the machine learning (ML) models predicting overall survival (OS) or response of the transplant-ineligible NDMM patients when treated by one of the two regimens-bortezomib plus melphalan plus prednisone (VMP) or lenalidomide plus dexamethasone (RD). Demographic and clinical characteristics obtained during diagnosis were used to train the ML models, which enabled treatment-specific risk stratification. Survival was superior when th

Utilization of novel systemic therapies for multiple myeloma: A retrospective study of front-line regimens using the SEER-Medicare data.

The landscape of treatment for multiple myeloma (MM) has significantly changed over the last decade due to novel agents that have shown superiority in efficacy such as proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs) over traditional therapies. However, the real-world utilization of these new agents has not been studied well. This study evaluated year-to-year changes in treatment choices in a cohort of patients aged 66 or older in the Surveillance, Epidemiology, and End Results (SEER) registry linked with Medicare claims (SEER-Medicare) data who were diagnosed with MM between 200