Darzalex Faspro (daratumumab and hyaluronidase-fihj) / J&J, Genmab, Halozyme - LARVOL DELTA

A phase 2 Study of teclistamab in combination with daratumumab in elderly patients with newly diagnosed multiple myeloma: The IFM2021-01 teclille trial, cohort a (ASH 2025) - P2 | "The IFM2021-01 trial is a phase 2study evaluating the doublets teclistamab-daratumumab (Cohort A) and teclistamab-lenalidomide(Cohort B) in frontline transplant-ineligible patients...Daratumumab SC (1800 mg) was given weekly in Cycles 1–2, every 2 weeks inCycles 3–6, and every 4 weeks thereafter...Conclusions. IFM2021-01 Cohort A demonstrates that an "all-antibody–based" doublet regimen ofteclistamab and daratumumab is highly effective and well-tolerated in elderly patients with NDMM, withdeep responses, high MRD negativity, and a favorable safety profile."

Clinical • Combination therapy • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia

Cilta-cel in lenalidomide-refractory multiple myeloma (CARTITUDE-4): an updated analysis including overall survival from an open-label, multicentre, randomised, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "The significantly improved overall survival and patient-reported measures in CARTITUDE-4 reinforce the use of cilta-cel in treating relapsed or refractory multiple myeloma as early as after first relapse."

Journal • P3 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology

(DARA)/BORTEZOMIB/LENALIDOMIDE/DEXAMETHASONE (D-VRD) WITH D-R MAINTENANCE (MAINT) IN TRANSPLANT-ELIGIBLE (TE) NEWLY DIAGNOSED MYELOMA (NDMM): ANALYSIS OF PERSEUS BASED ON CYTOGENETIC RISK (EBMT 2025) - P3 | "Background: In the primary analysis of the phase 3 PERSEUS study, subcutaneous DARA (DARA SC) + VRd induction/consolidation (ind/consol) and D-R maint improved progression-free survival (PFS) and increased rates of deep and durable responses vs VRd ind/consol and R maint in TE NDMM, regardless of cytogenetic risk. The addition of DARA SC to VRd ind/consol and to R maint provided clinical benefit in terms of PFS and induced higher rates of deep and sustained responses vs VRd ind/consol and R maint across all cytogenetic risk subgroups. This supports D-VRd ind/consol and D-R maint as a new standard of care for TE NDMM, regardless of cytogenetic risk. Clinical Trial Registry: https://www.clinicaltrials.gov/study/NCT03710603"

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Minimal residual disease dynamics in post-transplant patients with newly diagnosed multiple myeloma who received daratumumab plus lenalidomide versus lenalidomide alone as maintenance therapy in the auriga study (ASH 2025) - P3 | "In the phase 3 AURIGAstudy (NCT03901963), adding subcutaneous daratumumab (DARA SC) to R maintenance (D-R) improvedMRD-neg conversion (conv) and PFS in anti-CD38–naïve pts who were MRD pos post-ASCT. D-R maintenance provided benefit via increased MRD-neg rates, notably at 10–6, asevidenced by a >2.5-fold MRD-neg conv rate and an almost 10-fold sustained MRD-neg rate vs Rmaintenance alone. Pts achieving MRD-neg conv at 10–6 were less likely to have MRD-pos recurrence thanpts who attained MRD-neg conv at 10–5 only (but not at 10–6), and D-R pts were less likely to developMRD-pos recurrence than R pts. Pts who achieved deeper MRD neg (10–6) or sustained MRD neg (10–5 or10–6) showed a trend toward improved PFS vs pts with MRD-pos recurrence or who never achieved MRDneg, with few PD events observed in pts with MRD-neg conv."

Clinical • Minimal residual disease • Post-transplantation • Residual disease • Hematological Malignancies • Multiple Myeloma • Transplantation

IFM2017_03: Compare Lenalidomide and Subcutaneous Daratumumab vs Lenalidomide and Dexamethasone in Frail Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy (clinicaltrials.gov) - P3 | N=294 | Completed | Sponsor: University Hospital, Lille | Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Multiple Myeloma • Oncology

Efficacy and Safety of Daratumumab Plus VCd in Newly Diagnosed Amyloid Light-Chain Amyloidosis with Cardiac Involvement: A Pooled Analysis of Asian Patients from AMY2009 and AMY3001 (IMS 2026) - "Daratumumab plus bortezomib, cyclophosphamide, and dexamethasone (D-VCd) is the only approved frontline regimen for newly diagnosed AL (ND-AL) amyloidosis... D-VCd was observed to show deep and durable hematologic responses alongside clinical benefits and manageable safety profile in Asian patients with cardiac-involved ND-AL amyloidosis, consistent with the findings from the individual AMY2009 and AMY3001 studies. These data support D-VCd as an effective frontline option in this high-risk Asian patient population."

Retrospective data • Amyloidosis • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Malignancies

Home Based Subcutaneous Therapy in Elderly and Frail Patients with Multiple Myeloma: A Single Centre Real World Experience from India (IMS 2026) - "Regimens included SC Daratumumab and SC Bortezomib, combined with Pomalidomide, Lenalidomide, or Dexamethasone. Conclusions Home-based SC therapy is feasible, safe, and well-tolerated in elderly and frail MM patients in India, offering substantial reduction in hospital burden while preserving quality of life. Prospective studies are warranted to establish standardized protocols for home-based MM therapy in India Keywords: Multiple Myeloma · Home-based therapy · Subcutaneous Daratumumab · Bortezomib · Elderly · Frailty · Quality of Life · India"

Clinical • Real-world • Real-world evidence • Geriatric Disorders • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia

Efficacy and Safety of Daratumumab Plus VCd in Newly Diagnosed Amyloid Light-Chain Amyloidosis With Cardiac Involvement: A Pooled Analysis of Asian Patients From AMY2009 and AMY3001 (IMS 2026) - "Daratumumab plus bortezomib, cyclophosphamide, and dexamethasone (D-VCd) is the only approved frontline regimen for newly diagnosed AL (ND-AL) amyloidosis... D-VCd was observed to show deep and durable hematologic responses alongside clinical benefits and manageable safety profile in Asian patients with cardiac-involved ND-AL amyloidosis, consistent with the findings from the individual AMY2009 and AMY3001 studies. These data support D-VCd as an effective frontline option in this high-risk Asian patient population."

Retrospective data • Amyloidosis • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Malignancies

New model-based analysis further supports the potential of TECVAYLI (teclistamab-cqyv) plus DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) to redefine long-term survival expectations in early line relapsed/refractory multiple myeloma (PRNewswire) - "In the MajesTEC-3 study, TECVAYLI plus DARZALEX FASPRO significantly improved overall survival versus standard of care (SOC), with an estimated 83% of patients alive at 3 years...These data (Abstract #OA-58 and Abstract #OA-49) will be presented in two oral sessions at the International Myeloma Society (IMS) Annual Meeting...In this analysis, a relative survival mixture cure model was applied to patients treated with TECVAYLI plus DARZALEX FASPRO (n=291) and DPd/DVd (n=296) to assess whether long-term disease control could translate into outcomes approaching those of the general population. Best-fit models estimated cure fractions of 86.6% (95% confidence interval [CI], 81–91) for OS with the combination, compared with 0% (95% CI, 0–53) with DPd/DVd, with substantially greater uncertainty in the DPd/DVd estimates."

P3 data • Multiple Myeloma

Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: National Cancer Institute (NCI) | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

Updated Efficacy and Safety Results of Subcutaneous Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Therapy in Newly Diagnosed Multiple Myeloma After Transplant: AURIGA Study (IMS 2025) - P3 | "Updated efficacy and safety data from AURIGA continue to demonstrate the value of adding DARA SC to R maint., as evidenced by continued higher MRD-neg conversion rates and a PFS benefit, with no new safety signals observed."

Clinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Transplantation

Phase II Trial of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma (ASH 2024) - "Lenalidomide has been shown to delay progression in patients with high-risk smoldering multiple myeloma (HR-SMM) and curative intent trials in this population with carfilzomib-based therapy and stem cell transplantation have shown deep responses but generated concern for treatment-related toxicities and mortality...Treatment with D-RVD is 2 years (24, 28 day cycles) with daratumumab subcutaneous (SQ) per standard dose and schedule, bortezomib 1.3mg/m2 SQ on days 1, 8, 15 for cycles 1-6 then biweekly until completion of cycle 24, and lenalidomide 25mg on days 1-21 for cycles 1-6 followed by 15mg d1-21 from cycles 7-24 with low dose dexamethasone...Stem cell collection was successful in all eligible patients with an average stem cell yield of 4.89 x 106 CD34+ cells/kg, collected over median of 1 day. Conclusions : D-RVD in HR-SMM demonstrates significant activity, including a 98% ORR and high rates of MRD-negative disease, preventing progression to overt MM, with..."

P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Respiratory Diseases • Smoldering Multiple Myeloma • CD34

Early Intervention vs Observation in High-Risk Smoldering Multiple Myeloma: Pooled Evidence From Randomized Trials and Real-World Cohorts (SOHO 2026) - "In the phase 3 AQUILA trial (n = 390), compared with active monitoring, subcutaneous daratumumab significantly reduced progression risk (HR, 0.49; 95% CI, 0.36–0.67), the strongest phase 3 evidence for early intervention...The most common serious adverse events were neutropenia (24%), infections (22%), and thromboembolic events (8%); lenalidomide-based regimens also carried a risk of second primary malignancy... Early intervention significantly reduces progression and improves survival in high-risk SMM, with daratumumab demonstrating the most durable benefit. The 3.5-fold increase in serious adverse events necessitates careful patient selection and individualized shared decision-making. COI: SK: Advisor to J&J and Sanofi; research funding J&J, BMS."

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

Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) in transplant-eligible (TE) patients (pts) with newly diagnosed multiple myeloma (NDMM): Analysis of minimal residual disease (MRD) in the PERSEUS trial. (ASCO 2024) - P3 | "Research Funding: European Myeloma Network in collaboration with Janssen Research & Development, LLC. During maintenance, a greater proportion of pts with MRD-pos status achieved MRD neg with D-R vs R. The higher rates of deep (10 –6 ) and sustained MRD neg achieved with D-VRd ind/consol and D-R maintenance vs VRd ind/consol and R maintenance translated to a clinically meaningful benefit of improved PFS. These data further support D-VRd and D-R maintenance as a new standard of care for TE pts with NDMM and highlight the benefit of DARA SC in maintenance."

Clinical • Minimal residual disease • Residual disease • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Induction and extended consolidation with daratumumab, cyclophosphamide, bortezomib, lenalidomide, and dexamethasone in patients with high-risk multiple myeloma (OPTIMUM/MUKnine): 5-year follow-up of a multicentre, externally controlled, phase 2 trial. (PubMed, Lancet Oncol) - P2 | "OPTIMUM shows sustained progression-free survival and overall survival improvement with risk-stratified extended therapy, supporting implementation of molecular diagnostics and tailored treatment in patients with newly diagnosed high-risk multiple myeloma."

Journal • P2 data • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Transplantation

Timing And Outcomes of Second-Line Therapy in the Era of Daratumumab-Based Frontline Therapy in Amyloidosis (SOHO 2024) - "Background: The ANDROMEDA trial established daratumumab with bortezomib-cyclophosphamide-dexamethasone (Dara-VCd) as the standard of care for newly diagnosed immunoglobulin light-chain amyloidosis (NDAL) with unprecedented very good partial response (VGPR) rates or better of 80%... One-third of patients require a second LoT in the era of frontline Dara-VCd, mostly due to suboptimal hematologic response. Outcomes with subsequent LoTs remain favorable, with two-thirds achieving a ≥VGPR, mostly for t(11; 14) treated with venetoclax. Prospective studies on novel agents such as BCL2 inhibitors and bispecific antibodies are needed in this setting."

Clinical • Oncology

Phase II Trial of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma (ASH 2023) - "Lenalidomide has shown to delay progression in patients with high-risk smoldering multiple myeloma (HR-SMM) and curative intent trials with carfilzomib-based therapy and stem cell transplantation have been recently reported in HR-SMM leading to deep responses but with concern for treatment-related toxicities...Treatment with D-RVD is 2 years (24 cycles) with daratumumab subcutaneous (SQ) per standard dose and schedule, bortezomib 1.3mg/m2 SQ on days 1, 8, 15 for cycles 1-6 then biweekly until completion of cycle 24, lenalidomide 25mg on days 1-21 for cycles 1-6 followed by 15mg d1-21 from cycles 7-24 with weekly low dose dexamethasone... D-RVD in HR-SMM demonstrates significant activity, including a 100% ORR and high rates of MRD-negative disease, preventing progression to overt myeloma."

P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Respiratory Diseases • Smoldering Multiple Myeloma • CD34

MC210808 Venetoclax in Combination With Lenalidomide and Dexamethasone (Ven-Rd), Daratumumab and Dexamethasone (Ven-Dd), or Daratumumab-Lenalidomide-Dexamethasone (Ven-DRd) for the Treatment of Multiple Myeloma (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Mayo Clinic | Recruiting ➔ Active, not recruiting | N=100 ➔ 16 | Trial completion date: Dec 2028 ➔ May 2027 | Trial primary completion date: Dec 2028 ➔ May 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Interim Results of a Risk-Adaptive Phase II Study: Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab (KRD-Dara) in Newly Diagnosed Multiple Myeloma (NDMM) at the Levine Cancer Institute (LCI) (ASH 2022) - "Systemic injection reactions to subcutaneous daratumumab occurred in 5 (21.7%). The quadruplet regimen KRd-Dara as induction in NDMM leads to deep responses reflected in high rates of sCR and MRD negativity with an acceptable and well-tolerated safety profile. The stage 2 enrollment is ongoing."

P2 data • Bone Marrow Transplantation • Cardiovascular • Hematological Disorders • Hematological Malignancies • Hypertension • Infectious Disease • Multiple Myeloma • Neutropenia • Novel Coronavirus Disease • Oncology • Renal Disease • Transplantation • CD34

Subcutaneous daratumumab plus carfilzomib and dexamethasone (D-Kd) versus carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma who received previous daratumumab treatment: LYNX study. (PubMed, Leuk Lymphoma) - P2 | "No new safety concerns were identified. Future studies are needed to optimize daratumumab-based regimens for patients with RRMM who have prior daratumumab exposure."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

Stem Cell Mobilization Characteristics for Transplant Eligible Patients with Newly Diagnosed Multiple Myeloma (NDMM) Treated with Carfilzomib, Lenalidomide, Dexamethasone, and Daratumumab (KRd-Dara) (ASH 2022) - P2 | "Induction treatment consisted of 28-day cycles of KRd-Dara with intravenous carfilzomib, 20/56 mg/m2 (days 1, 8, and 15); lenalidomide orally, 25 mg (days 1-21); dexamethasone weekly; daratumumab (subcutaneous) per standard approved dosing schedule. The stem cell mobilization failure rate was high in patients collecting after 7 or 8 cycles KRd-Dara. Second remobilization with G-CSF and plerixafor was successful in only 1 of the 4 patients. We have modified stage 2 of the protocol to allow stem cell collection after cycle 3 of KRd-Dara induction."

Clinical • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation • CD34

AL (Kappa)-Type Ileocolonic Amyloidosis Presenting as Lower Gastrointestinal Hemorrhage: A Diagnostic Journey From Colonoscopic Biopsy to Systemic Diagnosis With Cardiac Sparing (ACG 2026) - "The patient was initiated on daratumumab plus cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) per the ANDROMEDA trial protocol...Systemic plasma cell-directed therapy remains the only durable intervention, making early hematologic diagnosis and treatment initiation the cornerstone of management. Figure: Sigmoid colon: blood Figure: ileocecal valve inflammation"

Biopsy • Amyloidosis • Atrial Fibrillation • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular • Chronic Kidney Disease • Nephrology • Renal Disease

The Impact of First-Line Daratumumab on Light-Chain Amyloidosis Survival: A Real-World Analysis of 70 Patients (SOHO 2026) - "Lenalidomide replaced bortezomib in three patients because of severe baseline neuropathy. The median duration of daratumumab treatment was 8 cycles, whereas cyclophosphamide was generally omitted... These real-world findings support the use of front-line daratumumab in AL amyloidosis. De-escalated dexamethasone dosing and a limited number of treatment cycles may maintain favorable clinical outcomes without jeopardizing efficacy."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Oncology

When Diabetes Isn't the Whole Story: Dara-CyBorD for Kappa Light Chain Deposition Disease Superimposed on Nodular Diabetic Nephropathy (SOHO 2026) - "Our case supports the efficacy of Dara-CyBorD in LCDD with coexisting diabetic nephropathy, thus contributing to the limited evidence for daratumumab-induced renal disease. Long-term follow-up is needed to assess durability of response and renal outcomes. AL: amyloid light; Dara-CyBorD, daratumumab, cyclophosphamide, bortezomib, and Decadron (dexamethasone); LCDD: light chain deposition disease."

Hematological Malignancies • Multiple Myeloma • Oncology

Daratumumab plus bortezomib, lenalidomide and dexamethasone for transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma: the randomized phase 3 CEPHEUS study. (PubMed, Nat Med) - P3 | "This phase 3 trial evaluated subcutaneous daratumumab plus VRd (D-VRd) in patients with transplant-ineligible NDMM or for whom transplant was not planned as the initial therapy (transplant deferred). The present study supports D-VRd quadruplet therapy as a new standard of care for transplant-ineligible or transplant-deferred NDMM. ClinicalTrials.gov registration: NCT03652064 ."

Journal • P3 data • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation