bortezomib / Generic mfg. - LARVOL DELTA

MajesTEC-9: A phase 3 randomized study of teclistamab monotherapy vs investigator's choice of pomalidomide, bortezomib, and dexamethasone or carfilzomib and dexamethasone (PVd/Kd) in patients (pts) with relapsed refractory multiple myeloma (RRMM). (ASCO 2026) - P3 | "Funded by Johnson & Johnson Clinical Trial Registration Number: NCT05572515 Background: Triplet and quadruplet regimens have greatly improved outcomes in newly diagnosed multiple myeloma, yet a high unmet need remains for more effective, broadly accessible treatments for anti-CD38- and lenalidomide- (Len) exposed/refractory RRMM...In MajesTEC-3, the synergistic Tec-daratumumab combination significantly improved progression-free and overall survival (PFS/OS) as early as first relapse... Tec monotherapy significantly improved PFS/OS vs standard of care (SoC) in this high unmet need population. CRS and infections were managed with established protocols. Results of phase 3 studies support Tec-based regimens as a SoC as early as second line, across all treatment settings and regardless of prior anti-CD38/Len exposure."

Clinical • Monotherapy • P3 data • Hematological Malignancies • Infectious Disease • Multiple Myeloma

CAREMM-011: CM336 Plus Isa-VR in Newly Diagnosed Primary Plasma Cell Leukemia (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Plasma Cell Leukemia

Teclistamab Therapy for Relapsed/Refractory Multiple Myeloma With High Disease Burden: Experience From an LMIC Community-Based Non-ICU Setting (SOHO 2026) - "With appropriate IVIG, antimicrobial, and tocilizumab prophylaxis, teclistamab can be safely administered in non-ICU LMIC community settings for patients with high-burden RRMM lacking access to advanced cellular therapies, giving a new lease on life to those who cannot travel for such treatments. ASCT: autologous stem cell transplantation, CART: chimeric antigen receptor T-cell, CRS: cytokine release syndrome, Dara-VLd: daratumumab, bortezomib, lenalidomide, and dexamethasone, ICANS: immune effector cell–associated neurotoxicity syndrome, ICU: intensive care unit, IVIG: intravenous immunoglobulin, RRMM: relapsed/refractory multiple myeloma."

Hematological Malignancies • Multiple Myeloma • Oncology

Patient-Reported Outcomes (PROs) of Teclistamab-Based Treatment (Tx) in Relapsed/Refractory Multiple Myeloma (RRMM) After 1-3 Lines of Therapy (LOT) (IMS 2026) - P3 | "Introduction: Significant PFS and OS benefits were seen with teclistamab + daratumumab (Tec-Dara) in MajesTEC-3 (NCT05083169) and Tec monotherapy in MajesTEC-9 (NCT05572515) vs controls ( Dara + dexamethasone [dex] + pomalidomide/bortezomib [DPd/DVd] in MajesTEC-3; pomalidomide + bortezomib + dex or carfilzomib + dex [PVd/Kd] in MajesTEC-9) in patients (pts) with RRMM and 1-3 prior LOT. Tec-Dara and Tec improved HRQoL and significantly prolonged time to symptom worsening vs controls. Building on transformative PFS, OS, and safety data, PROs support pt-relevant benefits, complementing improved pt experience with monthly dosing and steroid-sparing regimens. Findings reinforce Tec-based tx as SoC in 2L+ RRMM across practice settings."

Clinical • Patient reported outcomes • Hematological Malignancies • Infectious Disease • Multiple Myeloma

Overall Survival With Anti-BCMA Therapies: Indirect Comparison of Belantamab Mafodotin/Bortezomib/Dexamethasone vs Teclistamab/Daratumumab in Relapsed/Refractory Multiple Myeloma (SOHO 2026) - "BVd-treated patients were weighted using IPD to match Tec-Dara-treated patients for lenalidomide refractoriness, cytogenetic risk, prior LOTs, age, prior PI, prior daratumumab, and extramedullary disease. BVd demonstrated similar OS and lower infection odds vs Tec-Dara when adjusting for differences in key characteristics. These results highlight the benefit of targeting BCMA while offering insights into benefit-risk considerations. BVd: belantamab mafodotin, bortezomib, dexamethasone; CI: confidence interval; DPd: daratumumab, pomalidomide, dexamethasone; DVd: daratumumab, bortezomib, dexamethasone; LOT: line of therapy; OS: overall survival; PI: proteasome inhibitor; Tec-Dara: teclistamab plus daratumumab."

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

Teclistamab Plus Daratumumab (Tec-Dara) Versus Real-World Physician'S Choice of Therapy for Relapsed/Refractory Multiple Myeloma: Comparative Effectiveness Based on an Indirect Treatment Comparison (IMS 2026) - P3 | "Introduction: Tec-Dara significantly improved progression-free (PFS) and overall survival (OS) vs standard-of-care (SoC; Dara + dexamethasone + pomalidomide or bortezomib [DPd/DVd]) in patients (pts) with relapsed/refractory multiple myeloma (RRMM) and 1-3 prior lines of therapy (LOTs), in the phase 3 MajesTEC-3 study (NCT05083169)...An external cohort was created from the US Flatiron Health database, including pts who met key MajesTEC-3 criteria such as 1-3 prior LOTs, including a PI and lenalidomide (pts with 1 prior LOT were lenalidomide refractory), no prior BCMA-exposure or anti-CD38 mAb refractoriness (N=4224 observations from 2959 pts [Jan-2016 – Oct-2025])... Using IPTW-adjusted indirect comparisons in a large US RW cohort, Tec-Dara outperformed rwPC across a broad range of regimens in real-world practice, with significant improvements in PFS, OS and TTNT. These findings extend MajesTEC-3 results beyond the trial setting and support Tec-Dara as a robust,..."

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

TECLISTAMAB PLUS DARATUMUMAB (TEC-DARA) IN PATIENTS (PTS) WITH RELAPSED REFRACTORY MULTIPLE MYELOMA (RRMM): ANALYSIS OF MAJESTEC-3 BASED ON CYTOGENETIC AND FUNCTIONAL RISK (EHA 2026) - P3 | "Background Tec-Dara demonstrated significant improvement in PFS (primary endpoint) and all key secondary endpoints (including ≥CR, minimal residual disease [MRD] negativity [neg], and OS) vs Dara + dexamethasone + pomalidomide or bortezomib (DPd/DVd) in the primary analysis of the phase 3 MajesTEC-3 trial (NCT05083169) in early-line RRMM...Methods Pts had 1-3 prior lines of therapy (LOT) including a proteasome inhibitor and lenalidomide (lenalidomide refractory if only 1 prior LOT) with progressive disease (PD) on/after last LOT...The 36-mo PFS rates of 87.4% and 89.9% in pts with std. risk and non-FHR MM, respectively, and attenuation of the adverse prognosis associated with high-risk disease support Tec-Dara as a steroid-sparing standard-of-care as early as the 2nd LOT, across all practice settings and regardless of risk status."

Clinical • Hematological Malignancies • Multiple Myeloma

Phase 3 MajesTEC-9: Teclistamab Monotherapy vs Pomalidomide, Bortezomib and Dexamethasone or Carfilzomib and Dexamethasone (Pvd/Kd) in Chinese Patients with Relapsed Refractory Multiple Myeloma (RRMM) (IMS 2026) - P3 | "Introduction: Triplet and quadruplet regimens have greatly improved outcomes in newly diagnosed multiple myeloma, yet a high unmet need remains for more effective, broadly accessible treatments for anti-CD38- and lenalidomide- (Len) exposed/refractory RRMM...In MajesTEC-3, the synergistic Tec-daratumumab combination significantly improved progression-free and overall survival (PFS/OS) as early as first relapse... Consistent with the MajesTEC-9 overall population, Tec monotherapy significantly improved PFS and key secondary endpoints with manageable safety in Chinese RRMM pts with 1–3 prior LOTs. CRS and infections were generally manageable with established protocols. Results from phase 3 MajesTEC-9 study supports the medical adoption of Tec‑based regimens in Chinese pts as early as second‑line therapy regardless of prior anti-CD38/Len exposure."

Clinical • Monotherapy • P3 data • Hematological Malignancies • Infectious Disease • Multiple Myeloma

Single-Cell Phylogenetic Dynamics During Immunotherapy and at Minimal Residual Disease Timepoints in Multiple Myeloma (IMS 2026) - "To identify these cells, we used longitudinal single-cell whole-genome sequencing (scWGS) to characterize tumor cells, including rare MRD cells, from patients treated with quadruplet therapy (Daratumumab, Lenalidomide, Bortezomib, Dexamethasone; DRVd), anti-BCMA-directed T-cell-redirecting therapy (Teclistamab), or anti-BCMA CAR-T cell therapy (Cilta-cel). Longitudinal scWGS reveals that persistent tumor cells during immunotherapy and at MRD timepoints arise from genomically mature residual clones that continue to evolve under therapeutic pressure. scWGS enables detection of resistant subclones and target-antigen alterations below the sensitivity of bulk sequencing, providing insight into mechanisms of resistance and relapse evolution in MM."

IO biomarker • Minimal residual disease • Residual disease • Hematological Malignancies • Multiple Myeloma • Plasmacytoma • CD38 • SDC1 • TNFRSF17 • TP53

MRD-Guided Sequential Therapy for Deep Response in Newly Diagnosed Multiple Myeloma (NDMM)- Master-2 Trial (ASH 2024) - "Teclistamab (Tec), a bispecific antibody (BsAb) targeting BCMA, shows promise in refractory MM and, when combined with daratumumab (Tec-Dara), may help eliminate residual disease...Prior therapy exclusions apply, except for limited doses of dexamethasone, bortezomib, cyclophosphamide, lenalidomide, or daratumumab...The study seeks to determine if AHCT can be deferred in patients achieving MRD negativity after Dara-VRd without compromising the chance of reaching and sustaining MRD negativity, and whether post-AHCT Tec-Dara can enhance sustained MRD negativity rates compared to post-AHCT Dara-R in MRD-positive patients. The study is currently open for enrollment at multiple sites in the US."

Hematological Malignancies • Multiple Myeloma • Oncology

Patient-Reported Outcomes (PROs) of Teclistamab-Based Treatment (Tx) in Relapsed/Refractory Multiple Myeloma (RRMM) After 1-3 Lines of Therapy (LOT) (IMS 2026) - P3 | "Introduction: Significant PFS and OS benefits were seen with teclistamab + daratumumab (Tec-Dara) in MajesTEC-3 (NCT05083169) and Tec monotherapy in MajesTEC-9 (NCT05572515) vs controls (Dara + dexamethasone [dex] + pomalidomide/bortezomib [DPd/DVd] in MajesTEC-3; pomalidomide + bortezomib + dex or carfilzomib + dex [PVd/Kd] in MajesTEC-9) in patients ( pts) with RRMM and 1–3 prior LOT. Tec-Dara and Tec improved HRQoL and significantly prolonged time to symptom worsening vs controls. Building on transformative PFS, OS, and safety data, PROs support pt-relevant benefits, complementing improved pt experience with monthly dosing and steroid-sparing regimens. Findings reinforce Tec-based tx as SoC in 2L+ RRMM across practice settings."

Clinical • Patient reported outcomes • Hematological Malignancies • Infectious Disease • Multiple Myeloma

ISABELA: A phase 2 study of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed/refractory multiple myeloma. (ASCO 2026) - P2 | " ISABELA is an investigator-initiated study (NCT05922501) enrolling up to 50 patients (pts) with RRMM who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor...Prior therapies included pom (59%), bortezomib (82%), carfilzomib (41%), ixazomib (35%), CD38 antibody (59%) [daratumumab, 59%; isa 12%], and auto SCT (24%). Prior exposure to newer therapies included drugs that target BCMA (24%) [teclistamab 6%, elranatamab 18%, CAR T-cells 12%]; GPRC5D (12%) [talquetamab]; and cereblon (29%) [mezigdomide, 29%; cemsidomide, 12%]... This is the first report in RRMM for the combination of belamaf with a CD38 monoclonal antibody. The ISABELA regimen shows promising preliminary activity in RRMM with an ORR of 86% and 16-month PFS of 73%, including quad-class-exposed pts treated with anti-BCMA therapy, with manageable, reversible AEs."

P2 data • Cardiovascular • Hematological Malignancies • Hypertension • Infectious Disease • Multiple Myeloma • Neutropenia • Ophthalmology • Plasmacytoma • Thrombocytopenia • CRBN

HRMM-001: Safety and Efficacy of Elranatamab Plus Isatuximab, Bortezomib, and Lenalidomide in Ultra-High-Risk Multiple Myeloma (clinicaltrials.gov) - P2 | N=15 | Not yet recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology • TP53

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

CERVINO: Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P3 | N=421 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Hematological Malignancies • Multiple Myeloma • Oncology

Cost per Responder for Teclistamab-Daratumumab Versus Daratumumab, Pomalidomide, Dexamethasone (Dpd), and Daratumumab, Bortezomib, Dexamethasone (Dvd) in Relapsed Refractory Multiple Myeloma Patients (IMS 2026) - P3 | "The CP-CR+ were lower for TecDara vs DPd/DVd, despite the availability of generic pomalidomide and bortezomib. These data demonstrate that TecDara has better economic value driven by its unparallel deep efficacy, supporting its use in earlier LOTs."

Clinical • Hematological Malignancies • Multiple Myeloma

Matching-Adjusted Indirect Treatment Comparison of Teclistamab with Daratumumab (Tec-Dara) vs Belantamab with Bortezomib and Dexamethasone (Bvd) for Early-Line Relapsed/Refractory Multiple Myeloma (IMS 2026) - P3 | "Introduction: In the phase 3 MajesTEC-3 study (NCT05083169), Tec-Dara significantly improved PFS/OS vs Dara-based standard-of-care (SoC) in patients (pts) with RRMM and 1-3 prior lines of therapy (pLOTs). Tec-Dara showed clinical and statistically significant PFS/OS improvement, with a 78%/52% risk reduction, respectively, compared with BVd in the base-case MAIC. Moreover, Tec-Dara more than doubled the rate of ≥CR. Notably, MajesTEC-3 had a highly lenalidomide-refractory population (84% vs 34% in DREAMM-7); however, Tec-Dara’s comparative benefit persisted after robust, conservative MAIC adjustment, highlighting Tec-Dara’s ability to elicit deep and durable responses, supporting its use as a highly effective, fully immunotherapy-based, steroid-sparing SoC regimen in RRMM as early as first relapse."

Hematological Malignancies • Multiple Myeloma

Real-World Teclistamab in Heavily Pretreated Relapsed/Refractory Myeloma: Deep Responses, Infections, and Extramedullary Escape (IMS 2026) - "Median prior therapy lines were 6; all patients were exposed to daratumumab, bortezomib, and lenalidomide. Prior carfilzomib and pomalidomide exposure were present in 10 (66.7%) and 11 (73.3%) patients...Grade 3 ICANS occurred in 1 patient and resolved with dexamethasone and anakinra... Teclistamab produced deep responses in heavily pretreated RRMM despite universal prior anti-CD38, proteasome inhibitor, and immunomodulatory drug exposure. However, early progression, EMD escape, and infections remained key outcome determinants despite proactive IVIG and tocilizumab-based supportive care. These findings support structured infection-prevention pathways and close monitoring for aggressive/EMD relapse during BCMA bispecific therapy."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Nephrology • Septic Shock

Selinexor-Based Therapy in Multiple Myeloma: A Case Series Demonstrating Deep Responses in Heavily Pretreated Patients (SOHO 2026) - "Patients had extensive prior exposure to standard and novel antimyeloma therapies, including CyBorD, VRd, bortezomib/dexamethasone, lenalidomide maintenance, pomalidomide-based regimens, daratumumab, isatuximab, carfilzomib, belantamab mafodotin, radiation, autologous hematopoietic stem cell transplantation, and teclistamab. This case series highlights Seli as a clinically relevant and mechanistically novel therapeutic option capable of restoring disease control in heavily pretreated MM. Its activity across medically complex patients supports its role as an effective salvage or response-deepening strategy. CR: complete response; CyBorD: cyclophosphamide, bortezomib, and dexamethasone; MM: multiple myeloma; RR: relapsed/refractory; VRd: bortezomib, lenalidomide, and dexamethasone; XPO1: exportin 1."

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology • XPO1

Impact-AL: A phase 2 clinical trial of teclistamab and daratumumab in previously untreated AL amyloidosis (ASH 2025) - "Despite advances with daratumumab plus bortezomib-cyclophosphamide-dexamethasone(Dara-VCd) initial therapy, nearly half of the patients do not achieve hematologic complete response(heme-CR) by 6 months, highlighting the need for additional effective therapy...Principal exclusion criteria are NT-proBNP >8500 pg/mL, New York Heart Association IIIb or IVfunctional class, planned auto-transplant within 6 months, and concomitant multiple myeloma (exceptfor an isolated involved/uninvolved serum FLC ratio>100).Patients will receive subcutaneous teclistamab and daratumumab-hyaluronidase for six 28-day cycles.Teclistamab will follow the approved step-up dosing schedule, followed by treatment dosing.Daratumumab will be administered as per standard dosing...Clinical efficacy will be further evaluatedthrough rate and depth of organ response in heart, liver, and kidneys, major organ deterioration-progression free survival (MOD-PFS), and overall survival. Exploratory analysis..."

Clinical • P2 data • Amyloidosis • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders • Hematological Malignancies • Hypotension • Infectious Disease • Inflammation • Multiple Myeloma

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

Plasmacytomas in Extramedullary Manifestation of Multiple Myeloma: A Case Report. (PubMed, Clin Med Insights Case Rep) - "We report the case of a 59-year-old man with MM diagnosed in April 2024 who was treated with four cycles of bortezomib, cyclophosphamide, and dexamethasone (VCD), achieving remission with disappearance of serum and urine M-protein on immunofixation. In October 2025, the disease relapsed, with early progression despite treatment with daratumumab, prompting initiation of teclistamab therapy...Ultrasound-guided core biopsy revealed diffuse infiltration by monoclonal plasma cells expressing CD138 with lambda light-chain restriction, confirming secondary extramedullary plasmacytoma. This case highlights the importance of considering extramedullary plasmacytoma in the differential diagnosis of new superficial soft-tissue masses in patients with MM and underscores the complementary role of ultrasound and histopathological examination in establishing the diagnosis."

Journal • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Pain • Plasmacytoma • SDC1

Phase 1/2 dose escalation and expansion study of etentamig in patients with relapsed or refractory light chain amyloidosis (ASH 2025) - P1/2, P3 | "Thirty-three percent have received a prior stem celltransplant and 50% previously received the regimen of daratumumab with cyclophosphamide,bortezomib, and dexamethasone in combination. Additional dose-level datawill be presented at the time of the meeting. All pts remain in ongoing follow-up and evaluation, and thestudy will begin the dose expansion (EXP) portion after dose selection."

Clinical • P1/2 data • Amyloidosis • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Multiple Myeloma • Neutropenia • Thrombocytopenia

Phase 3 randomized study of teclistamab plus daratumumab versus investigator's choice of daratumumab and dexamethasone with either pomalidomide or Bortezomib (DPd/DVd) in patients (Pts) with relapsed refractory multiple myeloma (RRMM): Results of majestec-3 (ASH 2025) - P3 | " Eligible pts had 1-3 prior LOTs including a PI and lenalidomide (Len; pts with 1 prior LOT must have been Len-refractory) with progressive disease (PD) on or after the last LOT. We demonstrate the clinically remarkable and statistically significant PFS and OS benefits of Tec-Dara vs SoC triplets in RRMM, with 83.4% of Tec-Dara pts alive and progression-free at 3 yrs. Infections with Tec-Dara were well managed with established protocols. This highly effective, off-theshelf, immunotherapy combination represents a new SoC for RRMM as early as first relapse."

Clinical • IO biomarker • Late-breaking abstract • P3 data • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Plasmacytoma

Extramedullary Plasma Cell Dyscrasias Mimicking Solid Tumors: A Single-Center Case Series of Unusual Myeloma Presentations (SOHO 2026) - "The patient developed dialysis-dependent renal failure and hyperviscosity syndrome requiring emergent plasmapheresis followed by daratumumab-RVd...The patient required high-dose steroids, intrathecal chemotherapy, and salvage teclistamab-based therapy... This series highlights the diverse and deceptive manifestations of extramedullary plasma cell dyscrasias. Recognition of atypical relapse patterns is increasingly important in the era of BCMA-directed therapies, where progression may occur outside the marrow compartment despite apparent systemic remission. BCMA: B-cell maturation antigen, CA 19-9: carbohydrate antigen 19-9, CD: cluster of differentiation, CNS: central nervous system, CSF: cerebrospinal fluid, CT: computed tomography, CyBorD: cyclophosphamide, bortezomib, and dexamethasone, FDG: fluorodeoxyglucose, Ig: immunoglobulin, MRI: magnetic resonance imagery, PET: positron emission tomography, RVd: lenalidomide, bortezomib, and dexamethasone, SPEP: serum protein..."

Clinical • Multiple Myeloma • Oncology • Pancreatic Adenocarcinoma • Plasmacytoma • Solid Tumor • SDC1