Therapy Detail

Therapy Name Daratumumab
Synonym
Therapy Description

Darzalex (Daratumumab) is an antibody against CD38 that is FDA approved for multiple myeloma patients as a monotherapy and in combination with either Revlimid (lenalidomide) and Adexone (dexamethasone) or Velcade (bortezomib) and Adexone (dexamethasone) (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Daratumumab Darzalex Darzalex (Daratumumab) is an antibody against CD38 that is FDA approved for multiple myeloma patients as a monotherapy and in combination with either Revlimid (lenalidomide) and Adexone (dexamethasone) or Velcade (bortezomib) and Adexone (dexamethasone) (FDA.gov).
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 that supported FDA approval, Darzalex (daratumumab) treatment in multiple myeloma patients resulted in an overall response rate of 36% (15/42) with 2 patients having a complete response, 2 patients having a good partial response and 11 patients having a partial response (PMID: 26308596). 26308596
Clinical Trial Phase Therapies Title Recruitment Status
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
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
NCT03473730 Phase I Daratumumab Daratumumab in Patients With Metastatic Renal Cell Carcinoma (MRCC) or Muscle Invasive Bladder Cancer Recruiting
NCT03837509 Phase Ib/II Daratumumab + INCB001158 Daratumumab INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma Not yet recruiting
NCT03177460 Phase I Daratumumab JNJ-40346527 Daratumumab or FMS Inhibitor JNJ-40346527 Before Surgery in Treating Patients With High-Risk, Resectable Localized or Locally Advanced Prostate Cancer 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
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
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
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
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