Therapy Detail

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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 Revlimid (lenalidomide) and Adexone (dexamethasone), or with Velcade (bortezomib) and Adexone (dexamethasone), or with Velcade (bortezomib), Alkeran (melphalan), and Adasone (prednisone), or with Pomalyst (pomalidomide) and Adexone (dexamethasone) (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Daratumumab Darzalex JNJ-54767414 CD38 Antibody 7 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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown multiple myeloma not applicable Daratumumab FDA approved Actionable In a Phase I/IIb trial (GEN501) that supported FDA approval, Darzalex (daratumumab) treatment in patients with heavily pretreated and refractory multiple myeloma resulted in an overall response rate of 36% (15/42) in the 16 mg/kg cohort, with 1 complete response and 3 very good partial responses (PMID: 26308596; NCT00574288). detail... 26308596

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Clinical Trial Phase Therapies Title Recruitment Status
NCT03837509 Phase Ib/II Daratumumab + INCB001158 Daratumumab INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma Recruiting
NCT03537599 Phase Ib/II Daratumumab Daratumumab and Donor Lymphocyte Infusion in Treating Participants With Relapsed Acute Myeloid Leukemia After Stem Cell Transplant Recruiting
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 Active, not recruiting
NCT04150692 Phase II Daratumumab Escalation of Daratumumab Frequency Following Biochemical Progression in Relapsed/Refractory Multiple Myeloma Not yet recruiting
NCT02136134 Phase III Daratumumab Bortezomib + Dexamethasone Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma Active, not recruiting
NCT03622775 Phase II Daratumumab Daratumumab in Treating Participants With Relapsed Multiple Myeloma After Stem Cell Transplant Recruiting
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
NCT03477539 Phase II Daratumumab + Lenalidomide Daratumumab Daratumumab in Treating Transplant-Eligible Participants With Multiple Myeloma Recruiting
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 Recruiting
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 Active, not recruiting
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 Active, not recruiting
NCT03346135 Phase II Melphalan Daratumumab Daratumumab After Stem Cell Transplant in Treating Patients With Multiple Myeloma Recruiting
NCT03067571 Phase II Daratumumab Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome Recruiting
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 Active, not recruiting
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 Active, not recruiting
NCT03473730 Phase I Daratumumab Daratumumab in Patients With Metastatic Renal Cell Carcinoma (MRCC) or Muscle Invasive Bladder Cancer Recruiting


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