lenalidomide / Generic mfg. - LARVOL DELTA

Patient-reported outcomes following ciltacabtagene autoleucel or standard of care in patients with lenalidomide-refractory multiple myeloma (CARTITUDE-4): results from a randomised, open-label, phase 3 trial. (PubMed, Lancet Haematol) - P3 | "Health-related QoL improvements and delayed symptom worsening support cilta-cel's clinical efficacy in lenalidomide-refractory disease."

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

Long-Term Follow-Up of Patients With Multiple Myeloma Treated on Earlier Total Therapy Protocols: A Secondary Analysis of 3 Clinical Trials. (PubMed, JAMA Oncol) - P2, P3 | "Combinational chemotherapy and tandem hematopoietic stem cell transplant with the implementation of immunomodulatory drugs (thalidomide, lenalidomide) and proteosome inhibitor (bortezomib) extended therapy. Future studies are needed to evaluate the long-term benefits of newer generation treatments in MM. ClinicalTrials.gov Identifiers: NCT00580372, NCT00083551, NCT00081939."

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

GOLCADOMIDE (GOLCA), A CEREBLON E3 LIGASE MODULATOR (CELMOD™) AGENT ± RITUXIMAB (R), IN PATIENTS (PTS) WITH RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA (R/R FL): UPDATED PHASE 1/2 STUDY RESULTS (EHA 2025) - P1/2 | "Primary objectives included safety and RP2D determination.As of 30 Dec 2024, 12 pts received GOLCA in Part A, and 22 and 38 received 0.2mg and 0.4mg GOLCA+R in Part B. In Part B, median time (range) from initial diagnosis was 59 mo (10-420), median prior Tx lines was 3 (1-12), 28% had prior T-cell-directed Tx, 30% had prior lenalidomide (len) and 30% were refractory to last Tx.In Part A, 4 pts completed 2 y of GOLCA, remaining in remission at last f/u; 8 discontinued (d/c) due to PD. With additional f/u, GOLCA continued to show promising efficacy with durable responses and no new safety signals. A higher ORR and similar tolerability were observed with GOLCA 0.4mg +R vs GOLCA and GOLCA 0.2mg +R, including in pts with prior len-based and/or T-cell-directed Tx. These data support continued development of GOLCA 0.4mg +R as a fixed-duration, chemo-free, outpatient option in R/R FL, to be evaluated in the Ph3 GOLSEEK-4 study."

Clinical • P1/2 data • Anemia • Febrile Neutropenia • Follicular Lymphoma • Immune Modulation • Immunology • Infectious Disease • Lymphoma • Neutropenia • Targeted Protein Degradation • CRBN • IKZF1

BCMA CAR T-cell therapy in newly diagnosed primary plasma cell leukemia ineligible for transplantation: An open label, single-arm, phase 2 study (CAREMM-002) (ASH 2025) - P2 | "After 3–4 cycles ofVRd-based induction treatment, patients received lymphodepletion and a single infusion of BCMA CAR-Tcells (3×10⁶ cells/kg), followed by consolidation and lenalidomide maintenance... Frontline BCMA CAR-T therapy demonstrated unprecedented depth and durability ofresponse with manageable safety in transplant-ineligible PPCL patients-a population with historicallydismal outcomes and limited therapeutic options."

CAR T-Cell Therapy • Clinical • P2 data • Hematological Disorders • Hematological Malignancies • Leukemia • Leukopenia • Multiple Myeloma • Neutropenia • Plasma Cell Leukemia • Plasmacytoma • Thrombocytopenia • Transplantation

Primary analysis of the phase 3 randomized trial of selinexor and lenalidomide versus lenalidomide alone as maintenance therapy post autologous stem cell transplant for patients with newly diagnosed multiple myeloma (ALLG MM23; SEALAND) (ASH 2025) - P3 | "Introduction:Selinexor (S) is an oral selective exportin 1 inhibitor approved in relapsed multiple myeloma (MM) incombination with bortezomib (V) and dexamethasone (d)...Patients received ondansetron 8mg immediately prior to, and 8-hours following each S dose.Additional ondansetron and low-dose olanzapine were used as required for break-through nausea andvomiting...In this randomized phase III study, the addition of low-dose S to R maintenance following ASCT did notresult in a significant PFS benefit compared to R alone in NDMM. Although a higher CR rate was observedwith SR, this came at the cost of increased toxicity, including more infections, cytopenias andgastrointestinal AEs. Quality of life, as assessed by EORTC QLQ-C30 and MY20, was comparable betweenarms."

Clinical • P3 data • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Thrombocytopenia • Transplantation • XPO1

Long-term progression-free survival benefit with ciltacabtagene autoleucel in standard-risk relapsed / refractory multiple myeloma (ASH 2025) - P1/2, P3 | "Introduction: The CARTITUDE-4 study (NCT04181827), which enrolled patients with lenalidomide-refractory multiple myeloma (MM) after 1–3 prior lines of therapy (pLOT), demonstrated a significantbenefit of ciltacabtagene autoleucel (cilta-cel) over established triplet regimens...Here, we report outcomes inpatients with standard-risk cytogenetics from the intent-to-treat and as-treated populations inCARTITUDE-4. In CARTITUDE-4, patients randomized to the cilta-cel arm underwent apheresis and bridgingtreatment with either pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab,pomalidomide, and dexamethasone (DPd), followed by lymphodepletion therapy with cyclophosphamideand fludarabine, and then a single cilta-cel infusion... The PFS rate at 2.5 years for patients with standard-risk RRMM was higher in CARTITUDE-4compared with CARTITUDE-1, supporting the use of cilta-cel as early as second line in the treatmentcourse. In CARTITUDE-4 (as-treated..."

Hematological Malignancies • Multiple Myeloma

Efficacy and safety of a fully human BCMA CAR T-cell therapy for high-risk newly diagnosed transplant-ineligible multiple myeloma: Updated results from an open label, single-arm,phase 1 study(fumanba-2) (ASH 2025) - P1 | "Pts would undergo 4 cycles ofinduction chemotherapy based on one of three regimens: Bortezomib-Lenalidomide-Dexamethasone,Bortezomib-Cyclophosphamide-Dexamethasone, or Bortezomib-Adriamycin-Dexamethasone...After lymphodepletion with Fludarabine-Cyclophosphamide, pts received a single infusion of Eque-cel at the dose of 1.0 x 106 CAR-T cells/Kg.Primary endpoint was the proportion of minimal residual disease (MRD)-negative (MRD−; sensitivity <10-5) and progression-free survival (PFS)...Soluble BCMA was cleared within 1 month post infusion in 81.25% (13/16) of pts.Secretion of inflammatory cytokines was also observed, with median peak levels of 58.59 pg/mL (range:9.12-3017.83 pg/mL) for IL-6, 44.30 mg/L (range: 3.66-117.30 mg/L) for CRP, and 553.35 ng/mL (range:68.10-2349.00 ng/mL) for ferritin.In conclusion, the current data suggest that Eque-cel could be a promising and effective treatment optionfor high-risk NDMM pts following induction therapy. However, longer..."

CAR T-Cell Therapy • Clinical • P1 data • CNS Disorders • Hematological Disorders • Hematological Malignancies • Infectious Disease • Influenza • Multiple Myeloma • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Transplantation • IL6

Double hit ultra-high risk myeloma treated with isatuximab, bortezomib, lenalidomide, dexamethasone and cyclophosphamide (Isa-VRDc) induction and isa-VRD consolidation: Initial results of the UK myeloma research alliance (UKMRA) RADAR trial in newly diagnosed transplant eligible patients (ASH 2025) - "RADAR HRv4 pathway is the largest analysis of ultra-high risk (double hit) patients reportedto date. All participants meet the new IMS/IMWG HR criteria. Isa-VRDc induction, followed by Isa-VRDconsolidation post-ASCT and IsaR maintenance met the primary endpoint, with the study crossing theGreen design threshold, with 88% (59/67) alive and progression-free at 18 months."

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

Early rescue intervention with daratumumab, pomalidomide and dexamethasone (DPd) in high-risk smoldering myeloma (HR-SMM) patients included in the GEM-CESAR treated with carfilzomib, lenalidomide and dexamethasone (KRd)- autologous stem cell transplantation (ASCT)-krd-rd (ASH 2025) - "The achievement of MRD negativity at key time points—particularly after transplant and at the endof maintenance—was predictive of BP. Early rescue intervention with DPd was safe and effective; however,further studies are needed to better define which patients truly benefit from this approach and to determinethe optimal timing for intervention."

Clinical • Febrile Neutropenia • Infectious Disease • Multiple Myeloma • Neutropenia • Respiratory Diseases • Smoldering Multiple Myeloma • Transplantation

Etentamig plus pomalidomide-dexamethasone combination therapy in relapsed or refractory multiple myeloma: A phase 1b dose-escalation and safety expansion study (ASH 2025) - P1, P1/2 | "Arm A evaluated etentamig in combination with POM+DEX in pts after≥3 prior lines of therapy (LoT), including the IMiD lenalidomide, a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody (mAB). Preliminary data are promising and suggest etentamig in combination with POM+DEX istolerable with robust efficacy (ORR and ≥VGPR: 81% and 72%, respectively) in pts with ≥3 prior LoT(median LoT = 4). In this heavily pretreated population, median PFS was not reached with a median followup of 18 months, suggesting prolonged disease control with etentamig in combination with POM+DEX.Overall, these data support further exploration of the regimen in a randomized Phase 3 study."

Clinical • Combination therapy • P1 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Influenza • Multiple Myeloma • Neutropenia • Pneumonia • Renal Disease • Respiratory Diseases

Iberdomide maintenance after autologous stem-cell transplantation in newly diagnosed multiple myeloma: An update from the phase 2 EMN26 trial (ASH 2025) - P2 | "All pts received a PI/IMiD-containing induction regimen, which also includeddaratumumab in 53% of pts. These data support the investigation of iberdomide versus lenalidomide maintenance inthe ongoing phase 3 registrational EXCALIBER Maintenance trial. The dose of 0.75 mg iberdomide waschosen as the recommended maintenance dose for further evaluation, based on comparable efficacywith superior tolerability, compared to higher doses of iberdomide."

Clinical • P2 data • Cardiovascular • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Thrombocytopenia • Transplantation • Venous Thromboembolism

Iberdomide plus daratumumab and dexamethasone (IberDd) in patients with newly diagnosed multiple myeloma by renal function: A subgroup analysis of the CC-220-MM-001 trial (ASH 2025) - P1/2 | "Introduction: Lenalidomide (LEN) plus daratumumab (DARA) and dexamethasone (DEX) is a standard-of-care treatment for transplant-ineligible (TNE) newly diagnosed multiple myeloma (NDMM). Despite the observed numerical differences in ORR and CR between RI subgroups, logisticregression analyses showed no correlation between baseline CrCl and key efficacy and safety endpoints,suggesting that RI does not impact clinical outcomes in pts with TNE NDMM treated with IberDd, and thatIBER dose modifications are not required for pts with mild to moderate RI. These data are consistent withprevious observations in pts with RRMM receiving IBER+DEX."

Clinical • Febrile Neutropenia • Infectious Disease • Lymphoma • Multiple Myeloma • Neutropenia • Plasmacytoma • Renal Disease • CRBN • IKZF1

Whole genome sequencing of cell-free DNA for assessment of minimal residual disease in high-risk smoldering multiple myeloma (ASH 2025) - P2 | "We therefore tested the MRD performance oftumor-informed WGS of cfDNA in a low tumor-burden setting using longitudinal samples from aninterventional trial for high-risk smoldering MM (NCT01572480; carfilzomib, lenalidomide, anddexamethasone).MethodsMRDetect is an ultra-sensitive tumor-informed detection approach for MRD. Furthermore, cfDNA WGS serially tracked TF and was prognostic. Finally, LOD isexpected to be deeper in newly diagnosed and relapsed MM, where SNV burden for disease tracking ishigher."

Cell-free DNA • Minimal residual disease • Residual disease • Tumor mutational burden • Whole genome sequencing • Hematological Malignancies • Multiple Myeloma • Smoldering Multiple Myeloma • SDC1 • TMB

Effectiveness of bridging therapy corresponds to improved outcomes after ciltacabtagene autoleucel: Phase 3 CARTITUDE-4 study of patients with relapsed, lenalidomide-refractory multiple myeloma (ASH 2025) - "Patients in the cilta-cel arm underwent apheresis, received at least 1 cycle of bridging therapy(investigator's choice) with either pomalidomide, bortezomib, and dexamethasone (PVd) ordaratumumab, pomalidomide, and dexamethasone (DPd), lymphodepletion (cyclophosphamide andfludarabine), and then a single cilta-cel infusion 5–7 days after the start of lymphodepletion. In patients from CARTITUDE-4, better response to bridging therapy correlated with longerPFS and OS. No MNTs were observed in patients who achieved PR or greater following bridging therapy.Patients with poorer responses to bridging therapy were more likely to develop fatal infections,prolonged thrombocytopenia and neutropenia, and had higher rates of non-relapse mortality followingcilta-cel infusion. These data emphasize the importance of optimizing bridging therapy for diseasecontrol prior to receiving cilta-cel."

Clinical • P3 data • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Thrombocytopenia

Golcadomide (GOLCA), a potential, first-in-class, oral CELMoD™ agent, ± rituximab (R) in patients with Relapsed/Refractory follicular lymphoma (R/R FL): Phase 1/2 study extended follow-up Results (ASH 2025) - P1/2, P3 | "Median number of prior treatments was 4.5 (range, 2–6) in Part A and 3 (range, 1–12)in Part B Cohort D. Approximately one-third of the treated patients were exposed to prior T-cell–redirecting therapy, approximately one-third had prior lenalidomide (len) exposure, and approximatelyone-third were refractory to the last regimen received. A higher ORR/CRR and similar tolerability were observed with GOLCA 0.4 mg + R vsGOLCA 0.2 mg + R, including in patients with prior len-based and/or T-cell–redirecting treatment. Thesedata support continued development of GOLCA 0.4 mg + R as a fixed-duration, chemotherapy-free,outpatient option in the ongoing Phase 3 GOLSEEK-4 study in 2L+ FL (NCT06911502)."

Clinical • P1/2 data • Cardiovascular • Febrile Neutropenia • Follicular Lymphoma • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Lymphoma • Neutropenia • Pulmonary Embolism • Respiratory Diseases • CRBN • IKZF1

Fixed-duration teclistamab and talquetamab for frail patients with newly diagnosed multiple myeloma: The EMN37 fitfix study (ASH 2025) - "The combination of daratumumab with bispecific antibodies may lead to deeper and moredurable responses that could enable a lenalidomide- and a dexamethasone-sparing regimen including atreatment-free interval (TFI) in the first-line therapy of frail NDMM patients...However, noformal comparison of efficacy or safety between Tec-Dara and Tal-Dara will be performed.To mitigate the risk of potential side effects, dose modifications and adequate supportive care areplanned, including prophylactic tocilizumab administration and prophylactic intravenousimmunoglobulin (IVIG) supplementation therapy.The study will be conducted in Italy (14 sites), the Netherlands (9), Spain (4), and Norway (2)...Theupdated status of the study will be presented at the meeting.The study is conducted by the European Myeloma Network (EMN), in collaboration with HOVON, NMSG,EMN Italy, and PETHEMA and in collaboration with and with the financial support of JanssenPharmaceutica NV, a member of the Johnson..."

Clinical • Hematological Malignancies • Multiple Myeloma

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

Correlation between treatment-emergent cytopenias and clinical response with imetelstat (IME) in patients (Pts) with lower-risk myelodysplastic syndromes (LR-MDS): Analysis from the imerge Trial (ASH 2025) - P2/3 | "Introduction: IME is a first-in-class, direct, and competitive telomerase inhibitor approved for thetreatment (tx) of certain adult pts with LR-MDS with red blood cell (RBC) transfusion-dependent anemiawho are relapsed or refractory to/ineligible for erythropoiesis-stimulating agents. In this post hoc analysis, pts with ≥75% NEUT or ≥50% PLT reductions in the first 2 cycles ofIME tx were more likely to have greater Hb increases from pre-tx or to achieve an HI-E response. Thegreater Hb increase from pre-tx emerged as a main driver for achieving ≥8-wk and ≥24-wk RBC-TIresponses. Collectively, these data suggest that tx-emergent cytopenias with IME may be associated withpotential for clinical benefit, similar to lenalidomide in del5q MDS."

Clinical • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Neutropenia • Thrombocytopenia

Sustained minimal residual disease (sMRD) negativity in transplant ineligible newly diagnosed multiple myeloma treated with isatuximab plus lenalidomide and dexamethasone with bortezomib (Isa-VRd) versus isa-rd: 12-24-month data from the phase 3 benefit trial (IFM 2020-05) (ASH 2025) - P3 | "The BENEFIT study continues to support the efficacy of the quadruplet Isa-VRd regimen inNDMM TI patients, notably through improved sustained MRD negativity rates. These data support Isa-VRdas a new standard of care (SOC) for NDMM TI patients aged 65–79 years, including those with HRMM.ClinicalTrials.gov Identifier: NCT04751877"

Minimal residual disease • P3 data • Residual disease • Hematological Malignancies • Multiple Myeloma • Transplantation

Steroid-toxicity in newly diagnosed patients with multiple myeloma treated with a limited dexamethasone regimen; Results from the nmsg rest study (ASH 2025) - "Patients were treated with isatuximab-bortezomib-lenalidomide-dexamethasone; dexamethasone was omitted after two cycles, bortezomib was omittedafter eight cycles and isatuximab was omitted after 18 cycles. Steroids are included in most myeloma-targeted therapies. However, growing evidenceshows similar disease responses with steroid-limited treatments. Overall, we found a statisticalsignificant difference in steroid toxicity during cycles with dexamethasone compared to cycles withoutdexamethasone."

Clinical • Anorexia • CNS Disorders • Hematological Malignancies • Insomnia • Multiple Myeloma • Sleep Disorder

Tafasitamab, lenalidomide, and rituximab in relapsed or refractory follicular lymphoma (inMIND): a global, phase 3, randomised controlled trial. (PubMed, Lancet) - P3 | "The addition of tafasitamab to lenalidomide and rituximab resulted in a statistically significant and clinically meaningful improvement in progression-free survival, with an acceptable safety profile in patients with relapsed or refractory follicular lymphoma. This combination represents a potential new standard-of-care treatment."

Journal • P3 data • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Oncology

An open-label, multi-center Phase 2 study to assess the safety and efficacy of burixafor (GPC-100) and propranolol with G-CSF for the mobilization of hematopoietic progenitor cells in patients with multiple myeloma (ASH 2025) - P2 | "Mediantimes to neutrophil and platelet engraftment were 11 days (range 11-17 days) and 15 days (range 11-27days), respectively.ConclusionsBurixafor, in combination with propranolol and G-CSF, demonstrated an excellent safety profile andeffectively mobilized sufficient HPCs for AHCT, including patients previously treated with lenalidomideand daratumumab. Notably, burixafor enabled same-day administration with leukapheresis, offering akey advantage over other CXCR4 inhibitors, such as plerixafor and motixafortide through its rapidmobilization kinetics. Its favorable safety profile, characterized by minimal adverse events, supporting itspotential clinical utility."

Clinical • IO biomarker • P2 data • Cardiovascular • Constipation • Diabetes • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Hypotension • Multiple Myeloma • Musculoskeletal Diseases • Musculoskeletal Pain • CD34 • CXCR4

Epcoritamab monotherapy for Richter transformation (EPCORE CLL-1): findings from a single-arm, multicentre, open-label, phase 1b/2 trial. (PubMed, Lancet Haematol) - P1/2 | "In patients with Richter transformation, epcoritamab monotherapy showed clinically meaningful antitumour activity, although the investigator-assessed overall response rate was below the alternative hypothesis of 50%, with a safety profile consistent with previous studies. These findings support further investigation of epcoritamab as a potential treatment option for patients with Richter transformation."

Journal • Monotherapy • P1/2 data • B Cell Lymphoma • Cardiovascular • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • Richter's Syndrome • Septic Shock • Small Lymphocytic Lymphoma • Thrombocytopenia • TP53

Optimizing lenalidomide therapy in renal impairment: analysis of renal response in the prospective REMNANT study in transplant-eligible newly diagnosed multiple myeloma. (PubMed, Blood Cancer J) - "All patients received four 21-day cycles of induction with bortezomib, lenalidomide, and dexamethasone. Four RI patients (5%) experienced worsening renal function; two cases were possibly related to lenalidomide, both reversible. These findings support the safety and efficacy of increased lenalidomide-dosing during induction in TE-NDMM patients with RI, including those with severe impairment."

Journal • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Renal Disease • Thrombocytopenia • Transplantation

Quality-adjusted survival analysis of neurologic events with ciltacabtagene autoleucel (Cilta-cel) vs standard of care (SOC) in patients (Pts) with lenalidomide-refractory multiple myeloma (MM) who received 1–3 prior lines of therapy (LOT): Cartitude-4 trial population (Pop) (ASH 2025) - P3 | "Given that neurologic AEs, though infrequent, are a recognized consideration with CAR-T therapies suchas cilta-cel, this focused Q-TWiST analysis evaluated the specific impact of these events on quality-adjusted survival. In both base case and sensitivity scenarios, pts treated with cilta-cel experiencedstatistically significant and clinically meaningful gains in quality-adjusted survival vs SOC, with gainsexceeding the 10–15% threshold generally considered important in oncology. In the ITT pop, a significantimprovement was observed in time without neurologic AEs for cilta-cel vs SOC."

Clinical • CNS Disorders • Hematological Malignancies • Inflammation • Mental Retardation • Multiple Myeloma