Darzalex (daratumumab) / Genmab, J&J - LARVOL DELTA

Effective front-line treatment of osteosclerotic myeloma with POEMS syndrome with daratumumab, lenalidomide and dexamethasone: a case report and literature review. (PubMed, Acta Clin Belg) - "Front-line treatment with daratumumab, lenalidomide, and dexamethasone (DRd) resulted in a rapid and durable clinical and biochemical response, including normalization of vascular endothelial growth factor levels. This improvement ultimately enabled the patient to successfully undergo ASCT.This case highlights the potential role of DRd as an effective induction strategy in functionally impaired patients with POEMS syndrome."

Journal • Endocrine Disorders • Hematological Malignancies • Monoclonal Gammopathy • Multiple Myeloma • Oncology • Pain • Rare Diseases • Transplantation

The role of palliative care in the multidisciplinary treatment of immunoglobulin light chain amyloidosis (ASH 2025) - "Despite improved outcomes with daratumumab and bortezomib-based regimens, early mortality and poor quality of life remain clinically unmet needs. Despite high rates of hematologic response, AL amyloidosis patients are gravely affected by significant symptom burden due to delayed/absent organ recovery and/or treatment-related toxicities. Furthermore, AL amyloidosis patients and their families face critical decisions early in their disease course regarding utilization of advanced therapies, such as RRT or organ transplantation. PC interventions address a broad spectrum of needs—including physical, emotional, and psychosocial support—but referrals often occurred late in the disease course."

Amyloidosis • Anorexia • Hematological Malignancies • Multiple Myeloma • Palliative care • Plasmacytoma • Pulmonary Disease • Solid Organ Transplantation

Real-world impact of high-risk cytogenetics and revised ISS (R2 ISS) on response and survival in multiple myeloma patients treated with various induction regimens: A single-center study from India. (ASH 2025) - "Bortezomib-based triplet regimens, including VRd (bortezomib, lenalidomide, dexamethasone) and VCD (bortezomib, cyclophosphamide, dexamethasone), remain the preferred choices for induction therapy in India...Financial constraints in the indian setting restrict access to novel agents like daratumumab, influencing therapy choices... In this Indian cohort, high-risk cytogenetics and advanced RAISS stages independently predicted poorer survival. R2-ISS offered superior prognostic value over R-ISS. Standard-risk patients had similar outcomes with VRd and VCD, while KRd showed promise in a limited group."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma

Real-world insights into multiple myeloma management: An analysis of EHR-derived data in the UK and Germany (ASH 2025) - "Most common first-line therapy was daratumumab, lenalidomide, and dexamethasone in Germany (13%), and cyclophosphamide, bortezomib, and dexamethasone (24%) in the UK. The UK and Germany cohorts included 616 and 466 patients, respectively. In both countries, 75% of patients were diagnosed at ISS stage II or III. Cytogenetic testing was reported for 59% of patients in Germany, compared to 60% of the UK cohort, with 1q21 gain/amplification and del13q being the most commonly reported positive tests in both countries."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma

Ixazomib combined with daratumumab-based regimens as first-line therapy for transplant-ineligible patients with newly diagnosed multiple myeloma: A real-world historical database analysis from China (ASH 2025) - P2 | "The DI-based regimens included DICd (C: cyclophosphamide; d: dexamethasone) plus vinorelbine (VDS), DId plus VDS, DId plus denosumab, DId plus venetoclax (VEN), DIPd (P: pomalidomide), DIR (R: lenalidomide), and DIRd plus VEN. Conclusion The DI-based regimen, as an initial treatment option for transplant-ineligible NDMM patients, demonstrates efficacy comparable to that observed in previous prospective randomized controlled trials (RCTs) (NCT03012880, NTR6297, ORR: 71–96%). This real-world study conducted in China further supports the promising efficacy and acceptable safety profile of the ixazomib plus daratumumab-based regimen as a first-line treatment for transplant-ineligible NDMM patients in routine clinical practice, including among elderly patients with multiple comorbidities."

Clinical • Real-world • Real-world evidence • Cardiovascular • CNS Disorders • Diabetes • Hematological Disorders • Hematological Malignancies • Hepatology • Hypertension • Metabolic Disorders • Multiple Myeloma • Nephrology • Renal Disease • Transplantation • Vascular Neurology

Temporal trends in treatment patterns and overall survival for multiple myeloma management in Taiwan using the national health insurance claims database (ASH 2025) - "Since then, treatment for MM has continued to evolve, most notably with availability of anti-CD38 monoclonal antibodies such as daratumumab (D). We investigated temporal trends in MM treatment patterns and clinical outcomes from 2013 to 2022, a period encompassing onset of reimbursement for lenalidomide (R) in first line (1L) in patients with transplant-ineligible (TI) MM from February 2020, and D for second line (2L) and beyond from April 2020...Between study periods, VTd use in 1L (approximately 50% of patients) was unchanged, use of V(bortezomib)R-dexamethasone(d) increased from 0-17.59%, and use of regimens containing melphalan and alkylators decreased... The NHIRD provides health insurance for the whole population of Taiwan, allowing complete and longitudinal data collection across all treatment settings. We observed increased uptake of novel agents after their reimbursement under the National Health Insurance that coincided with a decrease in attrition rates and an..."

Claims database • Clinical • Reimbursement • US reimbursement • Hematological Malignancies • Multiple Myeloma

Comparison of elranatamab's progression-free survival, duration of response, and overall survival from MagnetisMM-3 versus real-world external control arms: A subgroup analysis of China-predominant treatment regimens (ASH 2025) - P2 | "Two China-specific physician's choice of therapy (CSPCT) subgroups were created by identifying patients receiving the predominant treatment regimens in China from the identified COTA cohort (CSPCT1: DVd, D-VMP, DKd, IxaDd, DRd, DPd, DRVd, DVTd; CSPCT2: daratumumab + [either carfilzomib or bortezomib or ixazomib] + any non-IMiD). In unweighted analyses vs CSPCT2, ELRA was associated with longer PFS (mPFS, 17.25 vs 4.93 months; HR, 0.55; 95% CI, 0.34-0.89; P <.05), numerically longer OS (mOS, 24.61 vs 14.95 months; HR, 0.70; 95% CI, 0.46-1.08; P =.11), and longer DOR (mDOR, NR vs 4.70 months; HR, 0.17; 95% CI, 0.07-0.41; P <.05). Conclusions Among BCMA-naive patients with RRMM who resemble those from the MM-3 trial, patients treated with ELRA have better outcomes than patients using the predominant treatment regimens available in China."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Leukemia • Multiple Myeloma • Plasma Cell Leukemia

Real-world survey of triplet versus quadruplet regimen preferences in transplant-ineligible (TIE) or deferred patients with newly diagnosed (ND) multiple myeloma (MM) (ASH 2025) - P3 | "Recently, data pertaining to anti-CD38 mAb-containing quadruplet regimens have been published (IMROZ: isatuximab ± bortezomib, lenalidomide, and dexamethasone [Isa-VRd]; NCT03319667 and CEPHEUS: daratumumab ± bortezomib, lenalidomide, and dexamethasone [Dara-VRd]; NCT03652064). The real-world data shows that Dara-VRd has emerged as the preferred regimen for non-frail, TIE/deferred patients with ND MM and that DRd is the preferred regimen for frail, TIE patients with ND MM. While interest for Isa-VRd saw a drastic increase for frail TIE patients with ND MM following review of the data, Dara-VRd was still the preferred anti-CD38 regimen if quadruplet regimens were considered. Despite the lack of a subgroup analysis of frail versus non-frail patients from CEPHEUS, Dara-VRd remains the preferred quadruplet therapy over Isa-VRd for TIE/deferred ND MM."

Clinical • Real-world • Real-world evidence • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Transplantation

Plasma cell leukemia: A single institution review of cases (ASH 2025) - "For salvage therapies, 4 patients received DCEP, 2 received PACE-based regimens, 1 patient achieved remission while on teclistamab, one had delayed ASCT (with third line therapy), and one received CAR-T therapy...There was no statistically significant difference in PFS1 (p = 0.86) or OS (p = 0.57) between patients who received conventional chemotherapy and those treated with a daratumumab-based quadruplet induction regimen. Of note, the majority of patients that received these quadruplet regimens did not receive lenalidomide or carfilzomib for induction of PCL. Although the results of this retrospective study showed that there was no significant difference in PFS1 and OS based on induction regimens, some patients received suboptimal regimens due to various constraints including prior treatment regimens, comorbidities, socioeconomic factors, and variabilities in access to care. Despite therapeutic advances in MM, PFS and OS in patients with both pPCL and sPCL remains..."

Clinical • Review • Endocrine Disorders • Hematological Disorders • Hematological Malignancies • Leukemia • Metabolic Disorders • Multiple Myeloma • Nephrology • Plasma Cell Leukemia • Renal Disease • RB1

Multiple myeloma treatment patterns in China: Analysis of the CancerMPact treatment architecture database (ASH 2025) - "The most common regimens in the 4L were KPd and DT-PACE-V (6% each), and the most common in 5L were equecabtagene autoleucel and DRVd (7% each). Although there is a lack of clear consensus at the regimen level, there are trends in the overall preferred regimen class. Patients with RRMM (2L-5L) were frequently treated with daratumumab-based regimens, often in combination with PIs, indicating the occurrence of therapeutic class recycling."

Hematological Malignancies • Multiple Myeloma • Oncology

A lean thinking approach to improve efficiency in providing immune-chemotherapy injection in out-patient service: A pivotal study (ASH 2025) - "Thus, room A can be dedicated to longer infusion times (> 2 hours, like CHOP, ABVD, obinotuzumab etc), B room for intermediate therapies (30 min-2 hours, like carfilzomib, decitabine), room D for short therapies (less than 10 minutes, like bispecific antibodies, daratumumab, bortezomib), room C for device maintenance and blood drawing, obtaining a further NVT reduction to 57 minutes but a NVTp worsening to 48%...Based on these scenarios, we developed an integrated software solution with AI functionality based on the automation of infusion station assignment, eliminating the distinction by pathology and length of treatment, reducing the average patient waiting time to 13 minutes, the in-patient stay to 23 minutes for short-term therapies, such as daratumumab and bispecifics, and 45 minutes for intermediate therapies such as isatuximab infusion. Conclusions Our approach proposes leveraging existing infrastructure resources, particularly infusion chairs, which are often..."

Clinical • Hematological Malignancies • Oncology

Comprehensive cost analysis of 4th line + therapies for relapsed/refractory multiple myeloma in Germany: Drug, co-medication, and office-based treatment perspective (ASH 2025) - "Whilst there is no official myeloma registry in Germany, treatments we considered were reimbursable combination therapies frequently used in the 4 th line treatment of RRMM in Germany in 2023, containing: carfilzomib, daratumumab, elotuzumab, melflufen, selinexor, talquetamab and teclistamab, and newly approved therapeutic options like elranatamab, along with evidence-based recommendations regarding premedication, comedication, and mandatory prophylaxis of treatment-related adverse events, as outlined in the Summary of Product Characteristics (SmPC) and published literature... Costs for myeloma drugs and combinations show a broad variation, from 88.863€ for Elotuzumab/Revlimid/Dexamethasone (ERd), to 178.850€ for talquetamab treatment. The second lowest in terms of annual costs was melflufen with 106.839€, followed by Elotuzumab/Pomalidomide/Dexamethasone (EPd):119.301€, teclistamab: 124.626€, Selinexor/Dexamethasone (Sd): 129.976€, elranatamab: 146.706€ and..."

Cost-analysis • HEOR • Hematological Malignancies • Multiple Myeloma

Etoposide +cytarabine plus G-CSF mitigates daratumumab-associated impairment on stem cell mobilization yields in multiple myeloma (ASH 2025) - "Objective: Quadruplet induction therapy comprising daratumumab(dara) and lenalidomide(lena), followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT) has become the standard frontline treatment for patient with multiple myeloma(MM). The median total CD34+ cells collection was 19.33 × 10⁶/kg in the dara group, significantly lower than that in lena group (25.59 × 10⁶/kg, p=0.005). Notably, patients receiving more than eight doses of dara showed a reduced CD34+ cell collection (median 14.16 × 10⁶/kg vs. 21.45 × 10⁶/kg; p = 0.039)."

Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Neutropenia • CD34

An exploratory study to evaluate the safety and efficacy of autologous CAR-T cells with dual targeting of BCMA and CD19 (FKC289 Injection) in subjects with relapsed or refractory systemic light chain amyloidosis (ASH 2025) - P=N/A | "Although the anti-CD38 monoclonal antibody daratumumab, combined with cyclophosphamide–bortezomib–dexamethasone (Dara-CyBorD), has recently been approved for newly diagnosed AL amyloidosis, effective options remain limited for relapsed/refractory patients (rr-ALA). This preliminary data shows FKC289 is promising in patients with rr-ALA with reaching hematological CR rapidly. Subsequent organ response is expected with long-term follow-up."

CAR T-Cell Therapy • Clinical • Amyloidosis • Hematological Malignancies

CRISPR/Cas9-mediated CISH deletion and CD16a upregulation potentiates ADCC in NK cells against relapsed/refractory multiple myeloma (ASH 2025) - "IFN-γ and TNF-α secretion were measured by ELISA, and specific lysis was measured by chromium release in in vitro cytotoxicity tests against MM.1S and U266 myeloma lines with and without daratumumab (10 µg/mL)...Conclusion In both preclinical in vitro and in vivo models, CRISPR/Cas9 deletion of CISH in conjunction with CD16a upregulation significantly increases NK-cell ADCC against RRMM. For patients who are not responding to current treatments, this dual-engineering strategy offers a promising next-generation cellular immunotherapy."

IO biomarker • Hematological Malignancies • Multiple Myeloma • FCGR3A • IFNG • TNFA

The development of FT839: An off-the-shelf CD19xCD38 dual-CAR T cell for the treatment of multiple myeloma (ASH 2025) - "In vitro cytotoxicity assays against MM cell lines RPMI-8226, OPM2, MM1.s and H929 demonstrated durable and potent cell cytotoxicity at low effector:target ratios, as a monotherapy with further deepening of response when combined with mAbs such as daratumumab or sarclisa, or T cell engagers such as teclistamab or talquetamab (exceeding 90% cytotoxicity in each case). Collectively, FT839 is engineered to eliminate cancer cells with broad and heterogenous antigen expression by a unique dual-CAR system and in combination with standard of care therapeutics, including mAbs and TCEs via hnCD16 and CD3-CFR transgenes, to overcome multiple challenges that have limited autologous CAR T-cell therapies in treating MM. Moreover, as an off-the-shelf CAR T-cell therapy, FT839 is intended for broad and on-demand access without the need for complicated and variable manufacturing processes or intense conditioning chemotherapy."

CAR T-Cell Therapy • IO biomarker • Hematological Malignancies • Multiple Myeloma

High risk MDS in the wke of anti-BCMA CART therapy in refractory multiple myeloma. (ASH 2025) - "Case Report We present the case of a female patient diagnosed with IgG multiple myeloma in 2015, initially treated with induction chemotherapy using lenalidomide, bortezomib, and dexamethasone (RVD), followed by autologous HSCT...She subsequently progressed on a combination of daratumumab, lenalidomide, and dexamethasone. Further disease progression occurred on a regimen of ixazomib, pomalidomide, and dexamethasone. She then achieved a temporary response to carfilzomib, lenalidomide, and dexamethasone, followed by a second autologous HSCT, but relapsed again after approximately one year of maintenance therapy...While this association warrants further investigation, it emphasizes the need for ongoing observation of patients who have received CAR T-cell therapy. Future studies should aim to clarify the potential mechanistic links, including clonal evolution, selective pressures imposed by immunotherapy, and the contribution of prior cytotoxic exposures."

IO biomarker • Acute Lymphocytic Leukemia • B Cell Lymphoma • Bone Marrow Transplantation • Cardiomyopathy • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • TP53

Real-world outcomes and toxicities of elranatamab (ELRA) in relapsed/refractory multiple myeloma: A retrospective analysis using the trinetx global health research network. (ASH 2025) - "Treatment exposure patterns indicated a heavily pretreated, triple-class refractory population: proteasome inhibitors (bortezomib 61%, carfilzomib 47%), IMiDs (lenalidomide 67%, pomalidomide 69%), and anti-CD38 monoclonal antibodies (daratumumab 67%). Additional therapies included CAR T-cell therapy (8%), autologous stem cell transplant (23%), Belantamab mafodotin (8%), Talquetamab (10%), and Teclistamab (8%)...Tocilizumab was used in 21% of patients... In comparison to the MagnetisMM-3 trial, this real-world analysis confirms the manageable immune toxicity profile of ELRA, with similarly low rates of grade ≥3 CRS and ICANS. However, the higher 6-month mortality (22.6%) observed in this cohort may reflect broader patient inclusion, including those with significant comorbidities and prior BCMA-directed therapies. Hematologic and infectious toxicities were substantial, reinforcing the need for enhanced monitoring and supportive care strategies in routine clinical use."

Real-world • Real-world evidence • Retrospective data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Influenza • Leukemia • Multiple Myeloma • Nephrology • Neutropenia • Plasma Cell Leukemia • Pneumonia • Respiratory Diseases • Septic Shock • Thrombocytopenia

Real-world outcomes and toxicities of talquetamab (Tal) in Relapsed/Refractory multiple myeloma (RRMM): A retrospective analysis using the trinetx global health research network. (ASH 2025) - "Treatment patterns reflected a triple-class refractory population, with high prior exposure to proteasome inhibitors (bortezomib 52%, carfilzomib 48%), IMiDs (lenalidomide 66%, pomalidomide 63%), and anti-CD38 antibodies (daratumumab 51%). Additionally, 35% had received CAR T-cell therapy, 39% underwent ASCT, 24% were treated with Teclistamab, and extramedullary disease and plasma cell leukemia were reported in 11% and 13% of patients, respectively...Grade ≥3 CRS and ICANS occurred in <10 patients each (2.4%), and 24% received tocilizumab for CRS... In this large, real-world cohort, Talquetamab demonstrated favorable short-term survival and a manageable safety profile, consistent with clinical trial data. The higher mortality observed may reflect the heavily pretreated, triple-class refractory population with advanced disease features and comorbidities often seen in real-world settings. Hematologic toxicities remained significant, while lower observed rates of..."

Real-world • Real-world evidence • Retrospective data • Dermatology • Multiple Myeloma • Neutropenia • Plasma Cell Leukemia • Thrombocytopenia

A single-center retrospective study of ixazomib-based regimens as maintenance therapy in newly diagnosed multiple myeloma (ASH 2025) - "Induction regimens included VRd (bortezomib-lenalidomide-dexamethasone, 57.4%), DVRd (daratumumab-bortezomib-lenalidomide-dexamethasone, 22.2%), and DVd (daratumumab-lenalidomide-dexamethasone, 9.3%). Notably, it effectively mitigates the adverse impact of high-risk genetic factors, positioning it as an emerging therapeutic option for high-risk NDMM maintenance therapy. Longer follow-up is warranted to confirm sustained survival benefits."

Retrospective data • Cardiovascular • Hematological Disorders • Hematological Malignancies • Hypertension • Multiple Myeloma • Thrombocytopenia

Preliminary analysis of a single-center study on chidamide combined with ICD regimen in bortezomib-exposed relapsed/refractory multiple myeloma patients (ASH 2025) - P2 | "Thus, we aimed to evaluate the efficacy and safety of chidamide combined with the ICD regimen (ixazomib, cyclophosphamide, dexamethasone) in RRMM patients exposed to bortezomib...All patients had received a median of 2 prior lines (range: 1–6), with 100% exposed to bortezomib and 90.9% to lenalidomide, 18.2% to ixazomib, 18.2% to carfilzomib, and 18.2% to daratumumab... Preliminary results demonstrate promising clinical efficacy and manageable safety of chidamide combined with ICD in RRMM patients double-exposed to bortezomib and lenalidomide. Further validation with larger cohorts and longer follow-up is warranted."

Clinical • Hematological Malignancies • Hepatology • Infectious Disease • Liver Failure • Multiple Myeloma • Pneumonia • Respiratory Diseases

Selinexor-based regimens in triple-class exposed or refractory multiple myeloma: A real-world analysis of efficacy and safety in 18 patients (ASH 2025) - "Treatment regimens included selinexor (40–60 mg/week) combined with the KPD regimen (carfilzomib, pomalidomide, dexamethasone) in 6/18 (33.3%) patients; other combinations comprised cytotoxic drugs, aponermin, daratumumab, and venetoclax. Selinexor-based regimens demonstrate clinically meaningful efficacy (ORR 66.7%, median PFS 10.9 months) and a manageable safety profile in heavily pretreated TCE/TCR RRMM patients. These findings support its use as a viable salvage therapy. Further validation through larger prospective trials is warranted to confirm these results."

Clinical • Real-world • Real-world evidence • Multiple Myeloma • Nephrology • Neutropenia • Plasma Cell Leukemia • Plasmacytoma • Renal Disease • Thrombocytopenia • XPO1

Impact of addition of anti-CD38 monoclonal antibody to first line therapy in newly diagnosed multiple myeloma with high risk cytogenetics: A systematic review and meta-analysis of randomized trials (ASH 2025) - "Daratumumab (DARA) and Isatuximab (ISA) are two FDA approved anti-CD38 mABs currently in use. Our study shows that addition of an anti-CD38 mAb significantly improves PFS in patients with NDMM with HRCA. This benefit seems to be primarily driven by studies utilizing DARA. No statistically significant benefit was observed for response end points such as MRD negativity in this subgroup highlighting the need for research to develop more effective regimens."

Retrospective data • Review • Hematological Malignancies • Multiple Myeloma

Real-world safety and efficacy of aponermin and selinexor-based regimens in patients with multiple myeloma (ASH 2025) - "Treatment regimens predominantly consisted of Apo+selinexor+dexamethasone (65.38%), with other combinations including Apo + daratumumab + selinexor + dexamethasone (11.54%), Apo + selinexor + carfilzomib + pomalidomide + dexamethasone (7.69%), Apo + selinexor + pomalidomide + dexamethasone (7.69%), Apo + selinexor + carfilzomib + dexamethasone (3.85%) and Apo + selinexor + cyclophosphamide + dexamethasone (3.85%). The median age was 66 years (range 29-82), with 65.38% male patients. R-ISS staging showed 11.54% stage I, 42.31% stage II, and 30.77% stage III. High-risk cytogenetic abnormalities included 1q21 gain/amplification (50.00%), t(4; 14) (19.23%), 17p deletion (15.38%) and double-hit HRCA (26.92%)."

Clinical • Real-world • Real-world evidence • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Leukemia • Leukopenia • Lymphoma • Multiple Myeloma • Thrombocytopenia

autologous hematopoietic cell transplantation (AHCT) in the era of novel therapies for multiple myeloma– real-world data from a single cente (ASH 2025) - "This study evaluates the long-term efficacy and outcomes of AHCT in a real-world cohort of MM patients receiving either daratumumab-based quadruplets or bortezomib-based triplets as induction therapy...Disease status at the time of transplantation showed complete response (CR) in 22 patients (49%) in Group A and 10 patients (28%) in Group B. Stem cell mobilization yielded a median of 3.42×10⁶ CD34⁺ cells/kg (range: 2.00–9.5) vs 4.11×10⁶ cells/kg (range: 2.00–9.3) and plerixafor was required in 59% vs 46% in Groups A and B and respectively .Median time to neutrophil and platelet engraftment was similar to both treatment groups [11 days in both groups for neutrophil (range: 9–13 and 7–13), and 13 days (range: 10–26) vs 11 days (range: 8–23) for platelet in Groups A and B...Conclusion Autologous stem cell transplantation remains an effective treatment option for multiple myeloma, even in the era of novel induction regimens. Daratumumab-based quadruplets do not..."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma • Plasmacytoma • Transplantation • CD34