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Therapy Name | Daratumumab |
Synonyms | |
Therapy Description |
Darzalex (Daratumumab) is a human antibody against CD38 that induces antibody-dependent cell-mediated cytotoxicity and complement-mediated cytotoxicity against CD38-positive tumor cells (PMID: 30546360). Darzalex (Daratumumab) is FDA approved for multiple myeloma patients as a monotherapy or in combination with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, or with bortezomib, melphalan, and prednisone, or with pomalidomide and dexamethasone, or with bortezomib, thalidomide and dexamethasone (FDA.gov). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Daratumumab | Darzalex | JNJ-54767414 | CD38 Antibody 20 | Darzalex (Daratumumab) is a human antibody against CD38 that induces antibody-dependent cell-mediated cytotoxicity and complement-mediated cytotoxicity against CD38-positive tumor cells (PMID: 30546360). Darzalex (Daratumumab) is FDA approved for multiple myeloma patients as a monotherapy or in combination with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, or with bortezomib, melphalan, and prednisone, or with pomalidomide and dexamethasone, or with bortezomib, thalidomide and dexamethasone (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT03004287 | Phase II | Melphalan Carfilzomib Cisplatin Cyclophosphamide Lenalidomide Dexamethasone Daratumumab Bortezomib Etoposide Doxorubicin Thalidomide | 2015-12: A Study Exploring the Use of Early and Late Consolidation/Maintenance Therapy | Active, not recruiting | USA | 0 |
NCT05438043 | Phase III | Daratumumab + Dexamethasone + Lenalidomide Daratumumab + Dexamethasone + Pomalidomide Daratumumab Carfilzomib + Daratumumab + Dexamethasone | A Study of Daratumumab | Recruiting | USA | POL | ITA | GRC | FRA | ESP | DNK | DEU | BEL | 4 |
NCT02195479 | Phase III | Bortezomib Daratumumab Melphalan | A Study of Combination of Daratumumanb and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma | Completed | USA | TUR | ROU | POL | HUN | HRV | GRC | GBR | ESP | DEU | CZE | BRA | BGR | BEL | AUS | ARG | 8 |
NCT04497961 | Phase II | Daratumumab Lenalidomide | A Study of Health-Related Quality of Life in People With Multiple Myeloma Receiving Daratumumab or Lenalidomide | Recruiting | USA | 0 |
NCT04922723 | Phase Ib/II | Daratumumab | Radiation/Temozolomide and Immunotherapy With Daratumumab to Improve Antitumor Efficacy in Glioblastoma (PRIDE) | Recruiting | USA | 0 |
NCT06232707 | Phase III | Carfilzomib Pomalidomide Elotuzumab Dexamethasone Daratumumab CC-93269 | A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (ALUMMINATE) | Withdrawn | USA | TUR | SWE | ROU | NOR | ITA | IRL | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG | 6 |
NCT03346135 | Phase II | Melphalan Daratumumab | Daratumumab After Stem Cell Transplant in Treating Patients With Multiple Myeloma | Active, not recruiting | USA | 0 |
NCT06636552 | Phase II | Daratumumab Bortezomib + Cyclophosphamide + Daratumumab + Dexamethasone | An Investigator-Initiated, Phase II, Multicenter, Open-Label, Single-Arm, Prospective Clinical Trial to Evaluate the Efficacy and Safety of Alternating Bortezomib-Based Regimens in Combination With DaratUMumab Followed by Maintenance With Daratumumab in the Frontline Setting of Primary Plasma CEll L (EUMELEIA) | Recruiting | GRC | 0 |
NCT02874742 | Phase II | Daratumumab Bortezomib + Dexamethasone + Lenalidomide | Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma | Completed | USA | 0 |
NCT03477539 | Phase II | Daratumumab + Lenalidomide Daratumumab | Daratumumab in Treating Transplant-Eligible Participants With Multiple Myeloma | Active, not recruiting | USA | 0 |
NCT01592370 | Phase Ib/II | Nivolumab Daratumumab + Nivolumab Daratumumab Ipilimumab + Nivolumab Daratumumab + Dexamethasone + Nivolumab + Pomalidomide Lirilumab + Nivolumab | An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma | Completed | USA | POL | ITA | GRC | FRA | BEL | 0 |
NCT03992170 | Phase II | Daratumumab | Study of Daratumumab in Multiple Myeloma (MM) Patients in >VGPR/MRD-positive (DART4MM) | Unknown status | ITA | 0 |
NCT05907759 | Phase II | Daratumumab | Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma | Recruiting | USA | 0 |
NCT03177460 | Phase I | Daratumumab Edicotinib | Daratumumab or FMS Inhibitor JNJ-40346527 Before Surgery in Treating Patients With High-Risk, Resectable Localized or Locally Advanced Prostate Cancer | Completed | USA | 0 |
NCT02136134 | Phase III | Daratumumab Bortezomib + Dexamethasone | Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma | Completed | USA | TUR | SWE | POL | NLD | HUN | ESP | DEU | CZE | BRA | AUS | 4 |
NCT03067571 | Phase II | Daratumumab | Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome | Terminated | USA | 0 |
NCT04150692 | Phase II | Daratumumab | Escalation of Daratumumab Frequency Following Biochemical Progression in Relapsed/Refractory Multiple Myeloma | Withdrawn | 0 | |
NCT04649060 | Phase III | Daratumumab + Dexamethasone + Melflufen Daratumumab | Study of Melphalan Flufenamide (Melflufen) in Combination With Daratumumab in Relapsed Refractory Multiple Myeloma (LIGHTHOUSE) | Terminated | POL | NOR | GRC | ESP | DEU | CZE | BGR | 4 |
NCT03837509 | Phase Ib/II | Daratumumab + INCB001158 Daratumumab | INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma | Terminated | USA | ESP | DEU | 0 |
NCT03432741 | Phase I | Carfilzomib Daratumumab Obinutuzumab Gemcitabine Trastuzumab Romidepsin Nivolumab Rituximab Belinostat Pembrolizumab | Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer | Suspended | USA | 0 |
NCT03622775 | Phase II | Daratumumab | Daratumumab in Treating Participants With Relapsed Multiple Myeloma After Stem Cell Transplant | Active, not recruiting | USA | 0 |
NCT01998971 | Phase I | Pomalidomide Bortezomib + Dexamethasone Melphalan Thalidomide Lenalidomide Prednisone Daratumumab Carfilzomib Diphenhydramine Montelukast | A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma | Completed | USA | FRA | ESP | 0 |
NCT04972942 | Phase I | Daratumumab | Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma (ALLO-T-DART) | Recruiting | USA | 0 |
NCT04656951 | Phase II | Daratumumab | Daratumumab for First Line Treatment of Transplant-ineligible Myeloma Patients Followed by Daratumumab Re-treatment at First Relapse (GMMG-DADA) | Recruiting | DEU | 0 |
NCT03473730 | Phase I | Daratumumab | Daratumumab in Patients With Metastatic Renal Cell Carcinoma (MRCC) or Muscle Invasive Bladder Cancer | Active, not recruiting | USA | 0 |
NCT03011034 | Phase II | Talacotuzumab Daratumumab | Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment | Completed | USA | NLD | ITA | ESP | BEL | 1 |
NCT03537599 | Phase Ib/II | Daratumumab | Daratumumab and Donor Lymphocyte Infusion in Treating Participants With Relapsed Acute Myeloid Leukemia After Stem Cell Transplant | Completed | USA | 0 |