^
    1d
    OCTANS: A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region) (clinicaltrials.gov)
    P3, N=220, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    bortezomib • Darzalex (daratumumab) • melphalan • Darzalex Faspro (daratumumab/hyaluronidase)
    9d
    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, N=57, Active, not recruiting, University of Michigan Rogel Cancer Center | Trial completion date: Feb 2026 --> Aug 2026 | Trial primary completion date: Feb 2024 --> Aug 2024
    Trial completion date • Trial primary completion date • Minimal residual disease
    |
    clonoSEQ
    |
    lenalidomide • bortezomib • Darzalex (daratumumab)
    9d
    Escalation of Doses of Daratumumab in Combination With Chemotherapy (Idarubicin and Cytarabine) in Patients of 60 Years Old or More With Adverse Risk Acute Myeloblastic Leukemia (AML) (DARALAM) (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, Nantes University Hospital | Trial completion date: Nov 2025 --> Jan 2028 | Trial primary completion date: Nov 2025 --> Jan 2028
    Trial completion date • Trial primary completion date • Combination therapy
    |
    cytarabine • Darzalex (daratumumab) • idarubicin hydrochloride
    11d
    Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM (clinicaltrials.gov)
    P2, N=43, Recruiting, Andrew Yee, MD | Trial completion date: May 2025 --> May 2026 | Trial primary completion date: May 2024 --> May 2025
    Trial completion date • Trial primary completion date
    |
    Darzalex (daratumumab) • carfilzomib • pomalidomide
    15d
    Fixed Duration vs Continuous Daratumumab in Transplant Ineligible Older Adults With Newly Diagnosed Multiple Myeloma (clinicaltrials.gov)
    P3, N=559, Recruiting, Canadian Cancer Trials Group | Not yet recruiting --> Recruiting
    Enrollment open • Head-to-Head
    |
    lenalidomide • Darzalex (daratumumab)
    16d
    FLT-3 mutation maybe an inferior predictor of daratumumab therapy in acute myeloid leukemia patients relapsed after allogeneic stem cell transplantation. (PubMed, Int J Lab Hematol)
    No abstract available
    Journal
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation
    |
    Darzalex (daratumumab)
    17d
    Pan Tumor Rollover Study (clinicaltrials.gov)
    P2, N=1500, Recruiting, Bristol-Myers Squibb | N=800 --> 1500 | Trial completion date: Aug 2025 --> Aug 2029 | Trial primary completion date: Aug 2025 --> Aug 2029
    Enrollment change • Trial completion date • Trial primary completion date • Pan tumor
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • Mekinist (trametinib) • Yervoy (ipilimumab) • 5-fluorouracil • Sutent (sunitinib) • temozolomide • capecitabine • Xtandi (enzalutamide capsule) • Cabometyx (cabozantinib tablet) • Rubraca (rucaparib) • Stivarga (regorafenib) • pemetrexed • oxaliplatin • Darzalex (daratumumab) • leucovorin calcium • Opdualag (nivolumab/relatlimab)
    17d
    SUN-RAY: Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell AntibodY (clinicaltrials.gov)
    P2, N=12, Recruiting, Children's National Research Institute
    New P2 trial
    |
    Darzalex (daratumumab) • Campath (alemtuzumab) • sirolimus
    18d
    The DART Study- Daratumumab Treatment in ITP (clinicaltrials.gov)
    P2, N=21, Active, not recruiting, Ostfold Hospital Trust | Trial primary completion date: Jan 2024 --> Apr 2024
    Trial primary completion date
    |
    Darzalex (daratumumab)
    19d
    IFm2022-01: Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma (clinicaltrials.gov)
    P2, N=103, Not yet recruiting, Nantes University Hospital
    New P2 trial • Minimal residual disease
    |
    lenalidomide • bortezomib • Darzalex (daratumumab) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv)
    23d
    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
    New P2 trial
    |
    lenalidomide • bortezomib • Darzalex (daratumumab)
    29d
    Belantamab Mafodotin, Lenalidomide, and Daratumumab for the Treatment of Relapsed, Refractory, or Previously Untreated Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=5, Completed, Mayo Clinic | Active, not recruiting --> Completed | Trial completion date: May 2026 --> Mar 2024 | Trial primary completion date: May 2025 --> Mar 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    lenalidomide • Darzalex (daratumumab) • Blenrep (belantamab mafodotin-blmf) • Hemady (dexamethasone tablets)
    30d
    Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=45, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Mar 2024 --> Aug 2024
    Trial completion date • Combination therapy
    |
    lenalidomide • Darzalex (daratumumab)
    1m
    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 completion date: Mar 2026 --> Oct 2028
    Trial completion date
    |
    lenalidomide • bortezomib • Darzalex (daratumumab)
    1m
    Efbalropendekin Alfa enhances human natural killer cell cytotoxicity against tumor cell lines in vitro. (PubMed, Front Immunol)
    Daratumumab (dara), a monoclonal antibody (mAb) that targets CD38 results in antibody-dependent cellular cytotoxicity (ADCC) of both multiple myeloma (MM) cells and NK cells. Because NK cells express CD38, XmAb24306 increases dara-mediated NK cell fratricide, but overall does not negatively impact the ADCC activity against a MM cell line likely due to increased NK cell activity of the surviving cells. These data show that XmAb24306 increases direct and ADCC-mediated human NK cell cytotoxicity in vitro.
    Preclinical • Journal • IO biomarker • Tumor cell
    |
    IL15 (Interleukin 15)
    |
    CD38 expression
    |
    Darzalex (daratumumab)
    1m
    A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-383 in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=270, Recruiting, TeneoOne Inc. | Trial completion date: Nov 2028 --> Jul 2031
    Trial completion date • Adverse events • Combination therapy
    |
    lenalidomide • Darzalex (daratumumab) • pomalidomide • Ogsiveo (nirogacestat) • ABBV-383 IV
    1m
    NCI-2018-02830: Daratumumab, Bortezomib, and Dexamethasone Followed by Daratumumab, Ixazomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=60 --> 40
    Enrollment closed • Enrollment change
    |
    bortezomib • Ninlaro (ixazomib) • Darzalex (daratumumab) • dexamethasone injection
    1m
    STOMP: Selinexor and Backbone Treatments of Multiple Myeloma Patients (clinicaltrials.gov)
    P1/2, N=300, Active, not recruiting, Karyopharm Therapeutics Inc | Phase classification: P1b/2 --> P1/2 | N=518 --> 300 | Trial completion date: Jan 2025 --> Apr 2027 | Trial primary completion date: Jan 2025 --> Apr 2027
    Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    lenalidomide • bortezomib • Xpovio (selinexor) • Ninlaro (ixazomib) • Darzalex (daratumumab) • carfilzomib • pomalidomide • Empliciti (elotuzumab) • Blenrep (belantamab mafodotin-blmf) • mezigdomide (CC-92480)
    1m
    DARDAR: Desensitization in Kidney Allograft Using Daratumumab (clinicaltrials.gov)
    P1/2, N=21, Completed, Assistance Publique - Hôpitaux de Paris | Recruiting --> Completed | Trial completion date: Nov 2024 --> Jun 2023 | Trial primary completion date: May 2024 --> Jun 2023
    Trial completion • Trial completion date • Trial primary completion date
    |
    Darzalex (daratumumab)
    1m
    A Study of Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab for Patients With Relapsed/Refractory Myeloma With Salvage Autologous Hematopoietic Cell Transplantation (clinicaltrials.gov)
    P2, N=41, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial completion date • Trial primary completion date
    |
    CD34 (CD34 molecule)
    |
    lenalidomide • Darzalex (daratumumab) • carfilzomib
    1m
    CD38 and BCL2 expression guides treatment with daratumumab and venetoclax in tagraxofusp-refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN) featuring dynamic loss of CD123. (PubMed, Leuk Res)
    No abstract available
    Journal • IO biomarker
    |
    BCL2 (B-cell CLL/lymphoma 2) • CD38 (CD38 Molecule) • CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    BCL2 expression
    |
    Venclexta (venetoclax) • Darzalex (daratumumab) • Elzonris (tagraxofusp-erzs)
    1m
    COLUMBA: A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P3, N=522, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed
    Trial completion
    |
    Darzalex (daratumumab) • Darzalex Faspro (daratumumab/hyaluronidase)
    1m
    A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects (clinicaltrials.gov)
    P1, N=172, Active, not recruiting, Shanghai Henlius Biotech | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Darzalex (daratumumab)
    1m
    CASTOR: Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P3, N=498, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Jan 2024
    Trial completion • Trial completion date
    |
    bortezomib • Darzalex (daratumumab) • Darzalex Faspro (daratumumab/hyaluronidase)
    2ms
    Copper 64Cu-DOTA-Daratumumab Positron Emission Tomography in Diagnosing Patients With Relapsed Multiple Myeloma (clinicaltrials.gov)
    P1, N=12, Completed, City of Hope Medical Center | Active, not recruiting --> Completed | N=21 --> 12 | Trial completion date: Dec 2023 --> Jun 2023
    Trial completion • Enrollment change • Trial completion date
    |
    Darzalex (daratumumab)
    2ms
    EQUULEUS: A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma (clinicaltrials.gov)
    P1, N=242, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    lenalidomide • bortezomib • Darzalex (daratumumab) • carfilzomib • pomalidomide • thalidomide • melphalan
    2ms
    Selinexor for the treatment of patients with relapsed or refractory multiple myeloma. (PubMed, J Oncol Pharm Pract)
    To improve the outcome of patients with relapsed/refractory multiple myeloma, it is critical to develop new therapies, assess potential therapeutic synergies, and overcome drug resistance by determining the efficacy of multiple myeloma therapies across multiple disease subgroups.
    Review • Journal • IO biomarker
    |
    XPO1 (Exportin 1)
    |
    lenalidomide • bortezomib • Xpovio (selinexor) • Darzalex (daratumumab) • carfilzomib • pomalidomide
    2ms
    Combination of Daratumumab and BD Regimen and Dapagliflozin in the Treatment of M-protein Related Cardiac Disease (clinicaltrials.gov)
    P=N/A, N=40, Not yet recruiting, Beijing Chao Yang Hospital
    New trial
    |
    bortezomib • Darzalex (daratumumab) • Farxiga (dapagliflozin)
    2ms
    Effect of prior lenalidomide or daratumumab exposure on hematopoietic stem cell collection and reconstitution in multiple myeloma. (PubMed, Ann Hematol)
    Our meta-analysis offers a comprehensive view of Len and Dara's impacts on hematopoietic stem cell collection and reconstitution in multiple myeloma. Len usage could lead to reduced stem cell collection, counteracted by plerixafor mobilization. Dara usage could result in diminished stem cell collection and delayed platelet engraftment.
    Review • Journal
    |
    CD34 (CD34 molecule)
    |
    lenalidomide • Darzalex (daratumumab) • plerixafor
    2ms
    DARVIVA: A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma (clinicaltrials.gov)
    P3, N=252, Recruiting, Biocad
    New P3 trial
    |
    Darzalex (daratumumab)
    2ms
    225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, City of Hope Medical Center
    New P1 trial
    |
    Darzalex (daratumumab) • sirolimus • melphalan • fludarabine IV
    2ms
    CD38-Specific Gallium-68 Labeled Peptide Radiotracer Enables Pharmacodynamic Monitoring in Multiple Myeloma with PET. (PubMed, Adv Sci (Weinh))
    In conclusion, [68 Ga]Ga-AJ206 exhibits the salient features required for clinical translation, providing CD38-specific high-contrast images in multiple models of MM. [68 Ga]Ga-AJ206-PET could be useful for quantifying total CD38 levels and pharmacodynamics during therapy to evaluate approved and new therapies in MM and other diseases with CD38 involvement.
    PK/PD data • Journal • IO biomarker
    |
    CD38 (CD38 Molecule)
    |
    CD38 expression
    |
    Darzalex (daratumumab) • Sarclisa (isatuximab-irfc)
    2ms
    CC-220-MM-001: A Study to Determine Dose, Safety, Tolerability, Drug Levels, and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Participants With Multiple Myeloma (clinicaltrials.gov)
    P1/2, N=532, Active, not recruiting, Celgene | Phase classification: P1b/2a --> P1/2 | Trial completion date: Oct 2029 --> Feb 2028 | Trial primary completion date: Oct 2029 --> Mar 2024
    Phase classification • Trial completion date • Trial primary completion date • Combination therapy
    |
    bortezomib • Darzalex (daratumumab) • carfilzomib • iberdomide (CC-220)
    2ms
    NCI-2018-01432: Daratumumab in Treating Participants With Relapsed Multiple Myeloma After Stem Cell Transplant (clinicaltrials.gov)
    P2, N=13, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Sep 2024 --> Apr 2025 | Trial primary completion date: Sep 2024 --> Apr 2025
    Trial completion date • Trial primary completion date
    |
    Darzalex (daratumumab)
    2ms
    CD46 and CD59 inhibitors enhance complement-dependent cytotoxicity of anti-CD38 monoclonal antibodies daratumumab and isatuximab in multiple myeloma and other B-cell malignancy cells. (PubMed, Cancer Biol Ther)
    The escape in the second treatment cycle was prevented by the pretreatment of cells with Ad35K++. Overall, our data demonstrate that Ad35K++ and rILYd4 are efficient co-therapeutics of daratumumab and isatuximab, specifically in multi-cycle treatment regimens, and could be used to improve treatment of multiple myeloma.
    Journal
    |
    CD59 (CD59 Molecule) • CD46 (CD46 Molecule)
    |
    Darzalex (daratumumab) • Sarclisa (isatuximab-irfc)
    2ms
    Epigenetic regulation of CD38/CD48 by KDM6A mediates NK cell response in multiple myeloma. (PubMed, Nat Commun)
    Inhibition of H3K27me3 with an EZH2 inhibitor resulted in CD38 and CD48 upregulation and restored sensitivity to Daratumumab. These findings suggest KDM6A loss as a mechanism of Daratumumab resistance and lay down the proof of principle for the therapeutic application of EZH2 inhibitors, one of which is already FDA-approved, in improving MM responsiveness to Daratumumab.
    Journal • IO biomarker
    |
    CD38 (CD38 Molecule) • KDM6A (Lysine Demethylase 6A) • CD48 (CD48 Molecule)
    |
    CD38 expression
    |
    Darzalex (daratumumab)
    2ms
    MajesTEC-2: A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (clinicaltrials.gov)
    P1, N=140, Active, not recruiting, Janssen Research & Development, LLC | Trial primary completion date: Jun 2024 --> Oct 2024
    Trial primary completion date
    |
    lenalidomide • bortezomib • Darzalex (daratumumab) • pomalidomide • Ogsiveo (nirogacestat) • Tecvayli (teclistamab-cqyv)
    2ms
    Dara-PD in the Treatment of Patients With First Relapse of Multiple Myeloma (clinicaltrials.gov)
    P=N/A, N=50, Not yet recruiting, FengYan Jin
    New trial
    |
    Darzalex (daratumumab) • pomalidomide
    2ms
    Selinexor, daratumumab, bortezomib and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma: results of the phase II, non-randomized, multicenter GEM-SELIBORDARA study. (PubMed, Haematologica)
    In lenalidomide refractory patients, a median PFS of 22.1 months was observed. 62% of the patients required dose modifications. In summary, although the primary endpoint of the study was not met, the combination of S-DVd showed encouraging clinical efficacy with a generally manageable safety profile representing a potential option for the treatment of RRMM patients.
    P2 data • Journal
    |
    XPO1 (Exportin 1)
    |
    lenalidomide • bortezomib • Xpovio (selinexor) • Darzalex (daratumumab)
    3ms
    Anti-CD38 monoclonal antibody impairs CD34+ mobilization and affects clonogenic potential in multiple myeloma patients. (PubMed, Blood Transfus)
    Our findings underscore the impact of daratumumab-based treatment on CD34+ mobilization in a real-life, upfront plerixafor-free population of NDMM patients. Higher probability of requiring multiple apheresis occurred among daratumumab-treated patients. Interestingly, the observation that daratumumab might negatively impact BFU-E colony formation, independent of CD34+ cell count, offers novel biological perspectives. Appropriate strategies should be adopted by the Apheresis teams to mitigate these potential negative effects.
    Journal • IO biomarker
    |
    CD34 (CD34 molecule)
    |
    Darzalex (daratumumab) • plerixafor
    3ms
    Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM (clinicaltrials.gov)
    P2, N=79, Active, not recruiting, Alliance Foundation Trials, LLC. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    lenalidomide • Ninlaro (ixazomib) • Darzalex (daratumumab) • dexamethasone injection
    3ms
    Daratumumab or FMS Inhibitor JNJ-40346527 Before Surgery in Treating Patients With High-Risk, Resectable Localized or Locally Advanced Prostate Cancer (clinicaltrials.gov)
    P1, N=33, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed
    Trial completion
    |
    Darzalex (daratumumab)