^
    1d
    Daratumumab Maintenance Therapy for Improving Survival in Patients with Light Chain Amyloidosis, EMILIA Trial (clinicaltrials.gov)
    P2, N=96, Recruiting, Mayo Clinic | Trial completion date: Nov 2024 --> Dec 2026
    Trial completion date
    |
    Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    3d
    Study of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia (ITP) (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Keymed Biosciences Co.Ltd | Phase classification: P1/2 --> P2 | N=36 --> 60
    Phase classification • Enrollment change
    3d
    TRANSCEND: A Trial of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR) (clinicaltrials.gov)
    P3, N=120, Not yet recruiting, HI-Bio, A Biogen Company
    New P3 trial
    |
    felzartamab (MOR202)
    9d
    Pharmacodynamic Signatures and Correlatives of Response in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Treated with Talquetamab or Teclistamab Plus Daratumumab and Pomalidomide (ASH 2024)
    P1 | "Tal-DP exhibits a deep, long-term impact on efficacy through complementary mechanisms of action and may be especially beneficial in pts with prior BsAb exposure, who typically have unfavorable BL immune profiles. Ongoing analyses of tec-DP from MajesTEC-2 (NCT04722146) will be presented."
    PK/PD data • Clinical
    |
    Darzalex (daratumumab) • pomalidomide • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
    14d
    TRIMM-2: A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma (clinicaltrials.gov)
    P1, N=290, Active, not recruiting, Janssen Research & Development, LLC | Trial primary completion date: Sep 2024 --> Aug 2025
    Trial primary completion date
    |
    pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
    15d
    GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies (clinicaltrials.gov)
    P1/2, N=252, Active, not recruiting, Genmab | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Darzalex Faspro (daratumumab and hyaluronidase-fihj) • GEN3014
    16d
    Rapid DFLC Response Predict CHR in AL Amyloidosis (clinicaltrials.gov)
    P=N/A, N=50, Recruiting, Peking University People's Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    bortezomib • cyclophosphamide • Darzalex (daratumumab) • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    17d
    IDA53: Evaluation of the Safety and Efficacy of the Association of Ibrutinib and Daratumumab in Relapsed/Refractory Chronic Lymphocytic Leukemia with P53 Dysfunction (clinicaltrials.gov)
    P2, N=29, Active, not recruiting, French Innovative Leukemia Organisation | Trial completion date: Jun 2026 --> Dec 2025
    Trial completion date
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Imbruvica (ibrutinib) • Darzalex (daratumumab)
    18d
    AQUILA: A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma (clinicaltrials.gov)
    P3, N=390, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Jul 2025 --> Dec 2025
    Trial completion date
    |
    Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    18d
    Phase I Trial of MT-0169 in CD38+ Acute Leukemia With Relapsed/Refractory or Measurable Residual Disease (clinicaltrials.gov)
    P1, N=0, Withdrawn, M.D. Anderson Cancer Center | N=52 --> 0 | Trial completion date: Jul 2030 --> Oct 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jul 2028 --> Oct 2024
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
    |
    MT-0169
    22d
    FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=9, Completed, Masonic Cancer Center, University of Minnesota | Trial completion date: Dec 2025 --> Oct 2024 | Active, not recruiting --> Completed
    Trial completion • Trial completion date
    |
    FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • CD38 (CD38 Molecule)
    |
    CD38 expression
    |
    cyclophosphamide • fludarabine IV • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • FT538
    22d
    Daratumumab in Treating Patients with Muscle Invasive Bladder Cancer or Metastatic Kidney Cancer (clinicaltrials.gov)
    P1, N=17, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Jun 2024 --> Jun 2026 | Trial primary completion date: Jun 2024 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Darzalex (daratumumab)
    23d
    DARATALL-VHR: Daratumumab in VHR T-ALL Treated According to the ALL National Treatment Program (clinicaltrials.gov)
    P2, N=31, Recruiting, Gruppo Italiano Malattie EMatologiche dell'Adulto | Not yet recruiting --> Recruiting | Trial completion date: Jan 2029 --> Oct 2029 | Initiation date: May 2024 --> Oct 2024 | Trial primary completion date: Jan 2029 --> Oct 2029
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
    |
    cyclophosphamide • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    28d
    miR‑1343‑3p inhibits autophagy by directly targeting ATG7 in multiple myeloma cells. (PubMed, Biomed Rep)
    Despite application of several new drugs, such as daratumumab, bortezomib/lenalidomide/dexamethasone, in combination with hematopoietic stem cell transplantation, overall prognosis remains poor and the pathological mechanism of MM is still unknown. The present findings suggested that miR-1343-3p may regulate ATG7 and autophagy by directly targeting the 3'UTR of ATG7. To the best of our knowledge, there are no direct data showing the roles of miR-1343-3p in development of MM; however, miR-1343-3p may be considered a potential target for MM treatment.
    Journal
    |
    ATG7 (Autophagy Related 7) • MIR134 (MicroRNA 134)
    |
    lenalidomide • bortezomib • Darzalex (daratumumab) • dexamethasone
    28d
    Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Goethe University
    New P2 trial
    |
    bortezomib • Sarclisa (isatuximab-irfc)
    29d
    A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma (NDMM) Patients Considered Frail or in a Subset of “Intermediate Fit” Comparing Upfront Three-Drug Induction Regimens Followed by Double- or Single-Agent Maintenance (SWOG-Fall 2024)
    R A N D O M I Z A T I O N Arm 1: Lenalidomide VRd-Lite (Bortezomib + Lenalidomide + Dexamethasone) Arm 2: Arm 3: DRd (Daratumumab and hyaluronidase-fihj + Lenalidomide + Dexamethasone) DRd (Daratumumab and hyaluronidase-fihj + Lenalidomide + Dexamethasone) Lenalidomide Daratumumab and hyaluronidase-fihj + Lenalidomide FALL 2024 SWOG MYELOMA 23 S2209/III Secondary Endpoints: To compare PFS in Arm 1 versus Arm 3. Among the nine patients on the DRD-DR arm evaluated for adverse events, there has been one treatment-related death from heart failure. Two additional patients experienced a Grade 4 adverse event as maximum grade (both hematologic).
    Clinical • P3 data
    |
    clonoSEQ
    |
    lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    29d
    Characterising how a single bout of exercise in people with myeloma affects clonal plasma cell and immune effector cell frequency in blood, and daratumumab efficacy in vitro. (PubMed, Brain Behav Immun Health)
    However, plasma cells were largely unchanged, and NK-cells expressing CD38 - the daratumumab target antigen - increased in blood. Future research should consider the optimal timings of exercise during daratumumab treatment in myeloma to avert exacerbation of daratumumab-mediated NK-cell lysis.
    Preclinical • Journal
    |
    PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • NCAM1 (Neural cell adhesion molecule 1) • SDC1 (Syndecan 1) • CD14 (CD14 Molecule) • FCGR2A (Fc fragment of IgG receptor IIa) • FCGR2B (Fc Fragment Of IgG Receptor IIb)
    |
    CD38 expression
    |
    Darzalex (daratumumab)
    30d
    Study of CM313 in Healthy Subjects (clinicaltrials.gov)
    P1, N=51, Recruiting, Keymed Biosciences Co.Ltd | Not yet recruiting --> Recruiting
    Enrollment open
    1m
    Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation (clinicaltrials.gov)
    P2, N=39, Not yet recruiting, UNC Lineberger Comprehensive Cancer Center | Initiation date: Sep 2024 --> Dec 2024
    Trial initiation date
    |
    lenalidomide • bortezomib • Darzalex (daratumumab) • dexamethasone
    1m
    Autologous Memory-like NK Cell Therapy With BHV-1100 and Low Dose IL-2 in Multiple Myeloma Patients (clinicaltrials.gov)
    P1, N=25, Recruiting, Biohaven Pharmaceuticals, Inc. | Trial completion date: Oct 2026 --> Dec 2024 | Trial primary completion date: Oct 2025 --> Dec 2024
    Trial completion date • Trial primary completion date • Minimal residual disease
    |
    CD34 (CD34 molecule)
    |
    BHV-1100
    1m
    A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia (clinicaltrials.gov)
    P2, N=41, Completed, Takeda | Active, not recruiting --> Completed | Trial completion date: Aug 2024 --> Apr 2024 | Trial primary completion date: Aug 2024 --> Apr 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    mezagitamab (TAK-079)
    1m
    Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): Analysis of minimal residual disease (MRD) in the PERSEUS study (DGHO 2024)
    Introduction: In the phase 3 PERSEUS study, subcutaneous (SC) DARA + VRd (D-VRd) induction/consolidation (ind/consol) and D-R maintenance (maint) increased PFS and depth of response (≥ complete response [CR] and MRD negativity [neg]) vs VRd ind/consol and R maint for TE NDMM. Higher rates of deep (10 –6 ) and sustained MRD neg with D-VRd ind/consol and D-R maint vs VRd ind/consol and R maint translated to improved PFS. These data support D-VRd and D-R maint as a new standard of care in TE NDMM and highlight the benefit of DARA SC in maint.
    Clinical • Minimal residual disease
    |
    clonoSEQ
    |
    lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    1m
    Daratumumab (DARA)/bortezomib/lenalidomide/dexamethasone (D-VRd) with D-R maintenance therapy (Maint) in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): Analysis of the PERSEUS study based on cytogenetic risk (DGHO 2024)
    Introduction: In the phase 3 PERSEUS study, subcutaneous (SC) DARA + VRd induction/consolidation (ind/consol) and D-R maint improved progression-free survival (PFS) and rates of deep, durable responses, including minimal residual disease (MRD) negativity (neg) vs VRd ind/consol and R maint in TE NDMM, regardless of cytogenetic risk. Adding DARA SC to VRd ind/consol and R maint significantly improved PFS and sustained response rates, supporting D-VRd ind/consol and D-R maint as a new SOC for TE NDMM, regardless of cytogenetic risk status.
    Clinical
    |
    clonoSEQ
    |
    lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    1m
    CEPHEUS: A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy (clinicaltrials.gov)
    P3, N=395, Active, not recruiting, Janssen Research & Development, LLC | Trial primary completion date: Aug 2025 --> May 2024
    Trial primary completion date
    |
    lenalidomide • bortezomib • dexamethasone • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    1m
    Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy (clinicaltrials.gov)
    P2; Trial completion date: Aug 2026 --> May 2026 | Trial primary completion date: Aug 2024 --> May 2024
    Trial completion date • Trial primary completion date
    |
    clonoSEQ
    |
    lenalidomide • bortezomib • Darzalex (daratumumab) • dexamethasone
    1m
    2015-12: a Study Exploring the Use of Early and Late Consolidation/Maintenance Therapy (clinicaltrials.gov)
    P2, N=50, Active, not recruiting, University of Arkansas | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2024 --> Oct 2025
    Trial completion date • Trial primary completion date
    |
    cisplatin • lenalidomide • bortezomib • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • Darzalex (daratumumab) • carfilzomib • thalidomide • melphalan
    1m
    Daratumumab in HLA Desensitization Prior to Transplantation (clinicaltrials.gov)
    P2, N=6, Enrolling by invitation, Barry A. Boilson | Trial completion date: Aug 2024 --> Aug 2025 | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial completion date • Trial primary completion date
    |
    Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    1m
    ALCYONE: A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma (clinicaltrials.gov)
    P3, N=706, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    bortezomib • Darzalex (daratumumab) • prednisone • melphalan • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • dexamethasone injection
    1m
    IONA-MM: A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) (clinicaltrials.gov)
    P=N/A, N=586, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting | N=1200 --> 586
    Enrollment closed • Enrollment change
    |
    carfilzomib • dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc)
    1m
    Targeting CD38 with monoclonal antibodies disrupts key survival pathways in paediatric Burkitt's lymphoma malignant B cells. (PubMed, Clin Transl Immunology)
    This study investigates the effectiveness of CD38-targeting monoclonal antibodies (mAbs), daratumumab and isatuximab, in impairing crucial cellular processes and survival pathways in pBL malignant cells. The study also revealed a correlation between CD38 and MYC expression levels in pBL patient samples, suggesting CD38 involvement in key oncogenic processes. The study emphasises the therapeutic potential of CD38-targeting mAbs, particularly isatuximab, in pBL.
    Journal • IO biomarker
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog)
    |
    MYC expression
    |
    Darzalex (daratumumab) • Sarclisa (isatuximab-irfc)
    1m
    Rapid dFLC Response Predict CHR in AL Amyloidosis (clinicaltrials.gov)
    P=N/A, N=50, Not yet recruiting, Peking University People's Hospital
    New trial
    |
    bortezomib • cyclophosphamide • Darzalex (daratumumab) • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    1m
    Phase 1, Open-label, Dose-escalation Trial with CD38-SADA:177 Lu-DOTA Drug Complex in Subjects with Relapsed or Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=30, Recruiting, Y-mAbs Therapeutics | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CD38 positive
    1m
    First use of 18F-FDG PET in TEMPI syndrome: can it be used for treatment assessment? A case report. (PubMed, Front Nucl Med)
    Post-treatment 18F-FDG PET (Daratumumab Bortezomib Thalidomide Dexamethasone) revealed a completely reduced signal of bone lesions, suggesting a complete response, which was substantiated both clinically and biologically, with the concurrent disappearance of telangiectasia and the monoclonal component, and the normalization of the EPO level. In future, additional data will be required to confirm the added value of 18F-FDG PET with TEMPI. Nevertheless, 18F-FDG PET can be a preferred tool for the extension workup and therapeutic evaluation of TEMPI syndrome.
    Journal • IO biomarker • FDG PET
    |
    JAK2 (Janus kinase 2) • CD38 (CD38 Molecule) • SDC1 (Syndecan 1)
    |
    JAK2 mutation
    |
    bortezomib • Darzalex (daratumumab) • dexamethasone • thalidomide
    1m
    SX-682 in Combination With Carfilzomib, Daratumumab-Hyaluronidase, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, Roswell Park Cancer Institute
    New P1 trial
    |
    carfilzomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • SX-682
    1m
    Daratumumab-bortezomib-dexamethasone (Dara-VCd) vs Bortezomib-Thalidomide-Dexamethasone (VTd), Then Maintenance With Ixazomib (IXA) or IXA-Dara (clinicaltrials.gov)
    P2, N=401, Active, not recruiting, Stichting European Myeloma Network | Trial completion date: Feb 2025 --> Feb 2026 | Trial primary completion date: May 2024 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    IGH (Immunoglobulin Heavy Locus)
    |
    bortezomib • cyclophosphamide • Ninlaro (ixazomib) • Darzalex (daratumumab) • thalidomide • melphalan
    2ms
    Isatuximab in Combination With Novel Agents in RRMM - Master Protocol (clinicaltrials.gov)
    P1/2, N=258, Recruiting, Sanofi | N=197 --> 258
    Enrollment change • Combination therapy
    |
    dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc) • evorpacept (ALX148) • Blenrep (belantamab mafodotin-blmf) • SAR439459 • pegenzileukin (SAR444245)
    2ms
    Phase 1b/2 trial of iberdomide in combination with daratumumab, dexamethasone +/- carfilzomib to eliminate MRD after induction therapy and ASCT in NDMM (IMW 2024)
    Iber-Dd and Iber-DKd are safe combinations and able to eliminate MRD persistent after modern induction therapy and ASCT in NDMM. This study is ongoing, complete safety and efficacy results from part 1 and updated results from part 2 will be presented at the meeting.
    Combination therapy • P1/2 data
    |
    CRBN (Cereblon)
    |
    clonoSEQ
    |
    Darzalex (daratumumab) • carfilzomib • dexamethasone • iberdomide (CC-220)
    2ms
    Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma (clinicaltrials.gov)
    P2, N=52, Active, not recruiting, Academic and Community Cancer Research United | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Chr t(4;14) • Chr t(14;16) • Chr del(1p)
    |
    Xpovio (selinexor) • Darzalex (daratumumab) • carfilzomib
    2ms
    A Study of Felzartamab in Participants With Lupus Nephritis (clinicaltrials.gov)
    P1, N=20, Recruiting, HI-Bio | Trial completion date: May 2025 --> Jun 2026 | Trial primary completion date: May 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    felzartamab (MOR202)
    2ms
    ANDROMEDA: A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis (clinicaltrials.gov)
    P3, N=416, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Aug 2024 --> Nov 2024
    Trial completion date • Combination therapy
    |
    bortezomib • cyclophosphamide • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    2ms
    Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies (clinicaltrials.gov)
    P1, N=8, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    2ms
    A Novel Tetravalent Bispecific Immune Cell Engager Activates Natural Killer Cells to Kill Cancer Cells without Mediating Fratricide. (PubMed, Antibodies (Basel))
    Notably, our findings showed that daratumumab-induced NK fratricide was restricted to CD38-CD38 crosslinking and was not related to ADCC via CD16a-CD38 crosslinking. This study is the first in the literature to show the successful engineering of a tetravalent immune cell engager composed of tandem VHH units, which achieves high affinity and anticancer activity without mediating fratricide.
    Journal • Immune cell
    |
    FCGR3A (Fc Fragment Of IgG Receptor IIIa)
    |
    Darzalex (daratumumab)