Darzalex (daratumumab)
/ Genmab, J&J
- LARVOL DELTA
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December 09, 2025
Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma.
(PubMed, N Engl J Med)
- P3 | "In patients with multiple myeloma who had received one to three previous lines of therapy, those in the teclistamab-daratumumab group had significantly longer progression-free survival than those in the DPd or DVd group. (Funded by Johnson & Johnson; ClinicalTrials.gov number, NCT05083169.)."
Journal • Hematological Malignancies • Multiple Myeloma • Oncology
June 26, 2026
Teclistamab-based induction treatment in transplant-eligible, newly diagnosed multiple myeloma: a phase 2 trial.
(PubMed, Nat Med)
- P2 | "In this prespecified pooled analysis of three cohorts, 49 patients received teclistamab/daratumumab/lenalidomide (Tec-DR; arms A and A1) or Tec-DR with bortezomib (Tec-DVR; arm B). Data support the feasibility of Tec-D(V)R induction in transplant-eligible NDMM, with a consistent safety profile compared with individual regimen components and notable early MRD negativity rates. ClinicalTrials.gov identifier: NCT05695508 ."
Journal • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Leukopenia • Multiple Myeloma • Neutropenia • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • Transplantation
September 11, 2026
Ixazomib, pomalidomide and dexamethasone in triple-class exposed multiple myeloma patients - a phase II study.
(PubMed, Haematologica)
- P2 | "Refractoriness rates to bortezomib, lenalidomide and daratumumab were 51%, 85% and 96% respectively. To conclude, the all-oral IPd regimen for TCE RRMM patients showed high response rates and a manageable safety profile, in a cohort enriched with TCR, elderly and frail patients. (NCT04790474)."
Clinical • Journal • P2 data • Hematological Malignancies • Multiple Myeloma • Oncology
September 16, 2026
Targeting CD38 with bispecific antibody XmAb 18968 in patients with relapsed/refractory acute myeloid leukemia and T-cell acute lymphoblastic leukemia.
(PubMed, Leukemia)
- P1 | "Prior lines of therapy (median 3, range 1-8) included venetoclax (77.3%), allogeneic HCT (22.7%), CD7 CAR-T cell therapy and daratumumab (11.1%). Median OS was 8.5 months in AML and 8.7 months in T-ALL. XmAb18968 is safe and tolerable with encouraging preliminary efficacy, supporting further investigation of CD38 targeting therapies in this setting (NCT05038644)."
Journal • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Neutropenia • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • Thrombocytopenia • CD7
August 23, 2026
MRD-Guided Frontline T-Cell Redirection Therapy for Newly Diagnosed High-Risk Multiple Myeloma Using Teclistamab-Daratumumab Intensification and Talquetamab-Daratumumab Early Rescue Intervention
(IMS 2026)
- P2 | "To evaluate the safety and preliminary efficacy of teclistamab-daratumumab (Tec-D) intensification following daratumumab-bortezomib-lenalidomide-dexamethasone (D-VRd) induction in ND-HRMM...CRS occurred in 7 patients (25%), all grade 1; only one required tocilizumab... Early MRD-guided incorporation of Tec-D intensification induced deep responses and high MRD-CR in ND-HRMM, supporting the evaluation of a full-immune based bispecific antibody-based, transplant-free approach in difficult to treat high-risk disease."
Late-breaking abstract • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Pneumonia • Respiratory Diseases
August 23, 2026
Long-Term Outcomes With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) Versus VRd in Transplant-Eligible Newly Diagnosed Multiple Myeloma (TE-NDMM) in the Phase 3 PERSEUS Study
(IMS 2026)
- "A fter 6.8 y m FU , PERSEUS showed that pts treated with DVRd induction/ consolidation and DR maintenance achieved among the deepest and most durable responses seen in phase 3 NDMM studies . I mproved overall and sustained MRD neg rates seen since the primary analysis translate d into improved PFS and PFS2 , with an emerging OS benefit , even after per-protocol MRD-guided discontinuation of Dara maintenance . These findings reinforce DVRd -DR as the standard of care in TE-NDMM."
IO biomarker • Late-breaking abstract • P3 data • Hematological Malignancies • Multiple Myeloma • Transplantation
August 23, 2026
The Benefit of Daratumumab Plus Bortezomib, Lenalidomide, and Dexamethasone (DVRd) on Depth and Durability of Response in the Phase 3 CEPHEUS Trial: Updated Minimal Residual Disease Analysis
(IMS 2026)
- "In this analysis of CEPHEUS, DVRd led to clinically meaningful, deep responses, with higher overall MRDneg rates, and reported for the first time, 60-mo sustained MRDneg rates vs VRd across all time points in the ITT, MRD-evaluable, and TIE populations, translating to improved survival outcomes. These data further demonstrate that continued treatment with DVRd improves and deepens responses over time vs VRd in pts with NDMM."
Minimal residual disease • P3 data • Residual disease
August 23, 2026
Multi-Center Phase II Trial of Iberdomide and SQ Daratamumab as Post-ASCT Maintenance Therapy in Pts With Multiple Myeloma (the IBEX Trial): Initial Safety Analysis and Interim Efficacy Results.
(IMS 2026)
- "Lenalidomide (LEN) is standard maintenance therapy. Addition of an anti-CD38 antibody such as daratumumab (DARA) increases MRD(-) responses and further improves outcomes...All pts received aspirin unless anticoagulated... Post-ASCT maintenance with IBER plus DARA is feasible and safe. Neutropenia was manageable at the doses used in IBEX. Improvements in IMWG response and MRD conversion were observed despite pre-ASCT quadruplet induction."
Clinical • P2 data • Cardiovascular • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Respiratory Diseases • Targeted Protein Degradation • CRBN
August 23, 2026
Iberdomide, Daratumumab, Dexamethasone (IberDd) vs Daratumumab, Bortezomib, Dexamethasone (DVd) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM): Results From EXCALIBER-RRMM Phase 3 Study
(IMS 2026)
- P3 | "This benefit was c onsistent across prespecified subgroups, including pts refractory to lenalidomide (LEN) in last LOT, pts with renal impairment, and ≥75y of age. IberDd led to a statistically significant and clinically meaningful improvement in MRD-negative CR vs DVd, with a manageable safety profile. IberDd represents an effective tx option for pts with RRMM as early as first relapse, that can be easily administered across diverse care settings."
Clinical • Late-breaking abstract • P3 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Renal Disease
August 23, 2026
First-Year Results of Isatuximab-Iberdomide Maintenance in MRD-Positive Newly Diagnosed Multiple Myeloma Patients Included in the Phase 3 MIDAS Trial
(IMS 2026)
- P3 | "While daratumumab plus lenalidomide maintenance has shown efficacy in recent studies (PERSEUS, AURIGA), no data are available regarding anti-CD38 combined with a CELMoD in maintenance... MIDAS (NCT04934475) is an ongoing phase 3 trial evaluating an MRD-adapted consolidation and maintenance strategy in TE-NDMM patients treated with six cycles of isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd)... Maintenance with isatuximab plus iberdomide after Isa-KRd induction and single or tandem ASCT is feasible with a manageable safety profile. This combination induced substantial MRD conversion during the first year of maintenance in patients remaining MRD-positive after consolidation. These findings support further evaluation of anti-CD38 plus CELMoD-based maintenance strategies in high-risk NDMM patients."
Clinical • IO biomarker • Minimal residual disease • P3 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia
August 23, 2026
5-Year Sustained Minimal Residual Disease (MRD) Negativity and Survival With Daratumumab Maintenance (D-Maint) in Transplant-Eligible (TE) NDMM: CASSIOPEIA Registry
(IMS 2026)
- "Introduction: CASSIOPEIA showed daratumumab, bortezomib, thalidomide, dexamethasone ( DVTd ) induction/autologous stem cell transplantation/consolidation improved outcomes vs VTd in TE - NDMM. After >8.5 y m FU with 96% retention, CASSIOPEIA registry data confirm deep and durable benefit of daratumumab tx . DVTd reduced risk of progression vs VTd by 38% and mortality by 39%. D - m aint demonstrated prolonged m PFS and PFS2 vs OBS ."
Clinical • Minimal residual disease • Residual disease • Transplantation
August 23, 2026
Projecting Functional Cure in Patients (Pts) With Relapsed/Refractory Multiple Myeloma (RRMM) in the MajesTEC-3 Study of Teclistamab-Daratumumab (Tec-Dara) Using a Mixture Cure Model
(IMS 2026)
- P3 | "Introduction: In the phase 3 MajesTEC-3 study (NCT05083169) , Tec-Dara significantly improved progression-free survival (PFS; HR 0.17; 95% CI 0.12–0.23) and overall survival (OS; HR 0.46; 95% CI 0.32–0.65) vs Dara plus dexamethasone with pomalidomide or bortezomib (DPd/DVd) in pts with RRMM and 1–3 prior lines of therapy ( median follow-up 34.5 mo) . Best fit models estimated >85% cure fractions for OS and PFS in Tec-Dara pts in MajesTEC-3. While functional cure does not imply biological/clinical cure, the analysis suggests that a substantial fraction of Tec-Dara-treated pts will experience a mortality risk and projected life expectancy similar to the general population. MajesTEC-3 is ongoing, and if continued follow-up confirms the model-based predictions, Tec-Dara may help redefine survival expectations in RRMM"
Clinical • Hematological Malignancies • Multiple Myeloma
August 23, 2026
Overall Survival, Progression and Non-Relapse Mortality With Teclistamab Plus Daratumumab (Tec-Dara) vs Dara-Based Triplets in Relapsed/Refractory Multiple Myeloma (RRMM): MajesTEC-3 Post Hoc Analysis
(IMS 2026)
- "Introduction: Tec-Dara showed significant survival benefits vs Dara + dexamethasone + pomalidomide/bortezomib (DPd/DVd) in MajesTEC-3 in early-line RRMM, a setting in which disease progression is the leading cause of death... Patients (pts) had 1–3 prior lines of therapy (LOT), including a proteasome inhibitor and lenalidomide (len; len-refractory if 1 prior LOT) with progression on/after last LOT... Tec-Dara significantly improved OS over DPd/DVd in pts with RRMM and 1–3 prior LOT. This analysis demonstrates that the observed OS benefit is driven by a profound reduction in disease progression, the leading cause of mortality in RRMM. Despite early curve crossing, Tec-Dara did not increase NRM."
Clinical • Retrospective data • Hematological Malignancies • Multiple Myeloma
August 23, 2026
Teclistamab Plus Talquetamab Consolidation in Newly Diagnosed Myeloma Patients With Positive Measurable Residual Disease After DVRD Induction : Interim Analysis of the Phase 2 Study IFM 2022-01
(IMS 2026)
- P2 | "IFM 2022-01 is a phase 2 trial evaluating tec plus tal or tec plus lenalidomide consolidation in TE-NDMM patients according to measurable residual disease (MRD) after Daratumumab Bortezomib Lenalidomide Dexamethasone (D-VRd) induction. The combination of tec+tal resulted in early and high undetectable MRD rates in NDMM patients with detectable MRD after D-VRD induction. These preliminary data showed no new safety signal was observed with tec+tal used in frontline."
Clinical • P2 data • Residual disease • Hematological Malignancies • Infectious Disease • Multiple Myeloma
August 23, 2026
Phase 2 Study of Talquetamab (Tal), Daratumumab (D), and Lenalidomide (R) as Induction Therapy in Patients (Pts) With Transplant Eligible Newly Diagnosed Multiple Myeloma (TE-NDMM): MajesTEC-5
(IMS 2026)
- " Eligible pts aged 18–70 years with TE-NDMM received Tal-DR induction therapy: Tal 0.8 mg/kg SC Q4W, preceded by 3 step-up doses in cycle (C)1; D 1800 mg SC QW in C1–2 and Q2W in C3–6; oral R 25 mg in C2–6; and dexamethasone 20 mg in C1–2 only. Tal-DR induction demonstrated promising early efficacy results in TE-NDMM, with rapid, deep responses and high MRD-negative rates. The gr 3-4 infection rate was lower than previously reported for the teclistamab induction therapy arms of this study, and no new safety signals emerged. This suggests pts at high risk for infection may benefit from targeting non-BCMA myeloma antigens."
Clinical • P2 data • Ataxia • Atopic Dermatitis • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Mood Disorders • Movement Disorders • Multiple Myeloma • Neutropenia • Otorhinolaryngology • Transplantation • Vertigo • CD34
August 29, 2026
Beneath the Ulcer: Uncovering Gastrointestinal AL Amyloidosis
(ACG 2026)
- "Case Description/ 50 year-old woman with kappa light-chain multiple myeloma and heart failure with reduced ejection fraction presented with epigastric and substernal pain.No NSAID use expect aspirin 81mg was reported. Multiple myeloma was well controlled on daratumumab and pomalidomide with stable serial bone marrow biopsies...She was started on pantoprazole 40 mg twice daily...(b) Surveillance endoscopy demonstrating a single large deep ulcer with a flat pigmented spot (Forrest IIC), with no interval healing despite prolonged high-dose proton pump inhibitor therapy. (c) Subsequent endoscopy with endoscopic ultrasound (EUS) showing interval improvement of the previously non-healing ulcer, now appearing as a 10 mm linear erosion."
Amyloidosis • Cardiovascular • Congestive Heart Failure • Gastroenterology • Gastrointestinal Disorder • Heart Failure • Hematological Malignancies • Multiple Myeloma • Peptic Ulcer
August 29, 2026
Hidden in Plain Sight: An Incidental Discovery of AL Amyloidosis on Liver Explant Pathology
(ACG 2026)
- "The patient initially deferred therapy but initiated daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) two months post-diagnosis. Transplant institutions may benefit from screening candidates who have unexplained cirrhosis or multi-organ morbidity for plasma cell dyscrasias. Figure: Figure 1: Illustrating hepatic amyloid deposits in the hepatic parenchyma (A), distribution in hepatic nodules (B), perisinusoidal with compression of hepatocyte cords/sinusoidal congestion (C), and effects on hepatocytes (D)."
Amyloidosis • Febrile Neutropenia • Fibrosis • Hepatology • Immunology • Infectious Disease • Liver Failure • Nephrology • Pneumonia • Respiratory Diseases • Septic Shock
August 29, 2026
Diverse Presentations of Hepatic Amyloidosis: A Case Series
(ACG 2026)
- "Due to systemic amyloidosis, she was deemed not a transplant candidate and discharged with plans for outpatient chemotherapy with daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD). Magnification of 10x, 20x and 40x, respectively. Figure 4: Special stains for Congo red demonstrates green refringence visualized upon polarized light."
Clinical • Amyloidosis • Cardiovascular • Cholestasis • Fibrosis • Hematological Disorders • Hepatology • Immunology • Inflammation • Liver Failure • Portal Hypertension • Renal Disease
August 29, 2026
AL Amyloidosis Masquerading as an Esophageal Disorder
(ACG 2026)
- "Due to poor functional status (ECOG 3), daratumumab was selected with palliative intent...Distal esophageal dilatation and food impaction Figure: Figure 1b. Underlying venous bleb after removal of food impaction"
Amyloidosis • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Hematological Disorders
August 29, 2026
Systemic Light-Chain Amyloidosis Mimicking Refractory Idiopathic Gastroparesis and Infiltrative Gastric Malignancy
(ACG 2026)
- "Early recognition facilitated life-saving hematological care with a daratumumab-based regimen targeting the underlying plasma cell dyscrasia...Figure: Figure 2. Polarized light microscopy demonstrating classic apple-green birefringence of Congo red-positive amyloid deposits, confirming amyloidosis."
Amyloidosis • CNS Disorders • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Diabetes • Gastrointestinal Disorder • Hematological Malignancies • Lymphoma • Metabolic Disorders • Oncology • Type 2 Diabetes Mellitus
August 29, 2026
When Bleeding Wonât Stop: GI Amyloidosis as the Culprit Behind Refractory Small Bowel Hemorrhage in Multiple Myeloma
(ACG 2026)
- "Treatment with daratumumab-based therapy was initiated, but multiorgan failure ensued, and the patient transitioned to comfort measures...Figure: Jejunal ulceration and polypoid protrusions. Figure: Scarring and loss of vascularity in the jejunum and proximal ileum."
Amyloidosis • Cardiovascular • Diabetes • Dyslipidemia • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Hypertension • Immunology • Inflammatory Bowel Disease • Metabolic Disorders • Multiple Myeloma • Nephrology • Renal Disease
August 29, 2026
Diffuse Colonic Ulcerations and Hematochezia Mimicking Ischemic Colitis in a Post-Hematopoietic Cell Transplant Patient With Strongyloides stercoralis Infection
(ACG 2026)
- "Case Description/ A 69-year-old male with IgA Kappa MM status post autologous HCT receiving daratumumab, pomalidomide, and dexamethasone presented with progressive weakness and failure to thrive over several months...Figure: Figure 1: Colonoscopy demonstrating erythema and ulceration at the hepatic flexure. Figure: Figure 2: Colonic biopsy demonstrating parasitic organisms (arrows) within the mucosa, with associated eosinophilic inflammation and giant cells involving the crypts and lamina propria."
Clinical • Atrial Fibrillation • Cardiovascular • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Hypotension • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Multiple Myeloma • Transplantation
August 29, 2026
An Unexpected Cause of Early Satiety: Gastric Amyloidosis in Smoldering Multiple Myeloma
(ACG 2026)
- "Treatment with daratumumab plus CyBorD (cyclophosphamide, bortezomib, dexamethasone) was initiated. Early recognition and multidisciplinary management are important, as AL amyloidosis with GI involvement carries a poorer prognosis. Figure: Congo-red stain of gastric biopsy: Apple-green birefringence under polarized light Figure: H&E: Gastric mucosa with amorphous, waxy, salmon pink material infiltrating small blood vessels and muscularis mucosa."
Amyloidosis • Anorexia • Atherosclerosis • Cardiovascular • Dyslipidemia • Dyspepsia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Hypertension • Multiple Myeloma • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder • Smoldering Multiple Myeloma
September 25, 2026
Sequential Autologous Stem Cell Transplantation and Ciltacabtagene Autoleucel for Concurrent Multiple Myeloma and Presumptive Immunoglobulin Heavy- and Light-Chain Amyloidosis in a Patient With Systemic Lupus Erythematosus.
(PubMed, Cureus)
- "The patient was treated with induction chemotherapy (carfilzomib, daratumumab, lenalidomide), followed by an autologous stem cell transplant (ASCT) in month eight. Persistent, mild cytopenias and an elevated B-type natriuretic peptide (BNP) prompted ongoing post-CAR-T supportive care and evaluation for cardiac amyloidosis. This case highlights the feasibility of combining ASCT with BCMA-directed CAR T-cell therapy and its association with continued hematologic and renal improvement in highly complex patients with overlapping plasma cell dyscrasias, amyloid deposition, and autoimmune disease."
Journal • Amyloidosis • Cardiac Amyloidosis • Cardiovascular • Chronic Kidney Disease • Glomerulonephritis • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Multiple Myeloma • Nephrology • Oncology • Renal Disease • Systemic Lupus Erythematosus • Transplantation • IGH
September 25, 2026
Safety and tolerability of anselamimab in participants with light chain amyloidosis: Results from a phase 2 study.
(PubMed, Eur J Cancer)
- P2 | "Anselamimab was well tolerated. Most common TEAEs were consistent with AL amyloidosis or anti-PCD therapy."
Journal • P2 data • Amyloidosis • Hematological Disorders
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