Clinical Trials Using Daratumumab

Clinical trials are research studies that involve people. The clinical trials on this list are studying Daratumumab. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 46
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  • Lenalidomide, and Dexamethasone with or without Daratumumab in Treating Patients with High-Risk Smoldering Myeloma

    This phase III trial studies how well lenalidomide and dexamethasone works with or without daratumumab in treating patients with high-risk smoldering myeloma. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and dexamethasone with daratumumab may work better in treating patients with smoldering myeloma.
    Location: 397 locations

  • Efficacy and Safety Study of bb2121 Versus Standard Triplet Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

    This is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of bb2121 versus standard triplet regimens in subjects with relapsed and refractory multiple myeloma (RRMM). The study is anticipated to randomize approximately 381 subjects with RRMM. Approximately 254 subjects will be randomized to Treatment Arm A and approximately 127 subjects will be randomized to Treatment Arm B.
    Location: 17 locations

  • Carfilzomib, Lenalidomide, Dexamethasone, Daratumumab, Melphalan, and Stem Cell Transplant in Treating Patients with Relapsed or Refractory Multiple Myeloma

    This phase II trial studies how well carfilzomib, lenalidomide, dexamethasone, daratumumab, melphalan, and stem cell transplant work in treating patients with multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Drugs used in chemotherapy, such as carfilzomib, lenalidomide, dexamethasone, and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient’s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving carfilzomib, lenalidomide, dexamethasone, daratumumab, melphalan, and stem cell transplant may work better in treating patients with multiple myeloma.
    Location: 13 locations

  • A Study to Determine Dose and Tolerability of CC-220 Monotherapy, in Combination With Dexamethasone, and in Combination With Dexamethasone and Daratumumab or Bortezomib in Subjects With Relapsed and Refractory Multiple Myeloma (MM)

    This is a multicenter, multi-country, open-label, Phase 1b / 2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 MonoT, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 MonoT and CC-220 in combination with DEX (DoubleT).
    Location: 13 locations

  • An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors

    The purpose of this study to investigate the safety and effectiveness of nivolumab, and nivolumab combination therapy, to treat patients who have virus-associated tumors. Certain viruses have been known to play a role in tumor formation and growth. This study will investigate the effects of the study drugs, in patients who have the following types of tumors: - Anal canal cancer-No longer enrolling this tumor type - Cervical cancer - Epstein Barr Virus (EBV) positive gastric cancer-No longer enrolling this tumor type - Merkel Cell Cancer - Penile cancer-No longer enrolling this tumor type - Vaginal and vulvar cancer-No longer enrolling this tumor type - Nasopharyngeal Cancer - No longer enrolling this tumor type - Head and Neck Cancer - No longer enrolling this tumor type
    Location: 10 locations

  • Myeloma-Developing Regimens Using Genomics (MyDRUG)

    The MyDRUG study is a type of Precision Medicine trial to treat patients with drugs targeted to affect specific genes that are mutated as part of the disease. Mutations in genes can lead to uncontrolled cell growth and cancer. Patients with a greater than 30% mutation to any of the following genes; CDKN2C, FGFR3, KRAS, NRAS, BRAF V600E, IDH2 or T(11;14) can be enrolled to one of the treatment arms. These arms have treatments specifically directed to the mutated genes. Patients that do not have a greater than 30% mutation to the genes listed can be enrolled to a non-actionable treatment arm. The genetic sequencing of the patient's tumor is required via enrollment to the MMRF002 study: Clinical-grade Molecular Profiling of Patients with Multiple Myeloma and Related Plasma Cell Malignancies. (NCT02884102).
    Location: 10 locations

  • A Biomarker-Directed Phase 2 Trial of SY-1425 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

    The purpose of this study is to determine the activity of SY-1425 in relapsed / refractory acute myeloid leukemia (AML) patients (SY-1425 administered as a monotherapy or in combination with azacitidine), relapsed / refractory higher-risk myelodysplastic syndrome (MDS) patients (SY-1425 administered as a monotherapy or in combination with daratumumab), newly diagnosed treatment naïve AML patients who are unlikely to tolerate standard intensive chemotherapy (SY-1425 administered as a monotherapy or in combination with azacitidine), or lower-risk myelodysplastic syndrome (MDS) patients (SY-1425 administered as a monotherapy).
    Location: 9 locations

  • A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed / Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

    The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed / refractory B-cell acute lymphoblastic leukemia (ALL) / lymphoblastic lymphoma (LL) and T-cell ALL / LL as measured by the complete response (CR) rate.
    Location: 12 locations

  • Daratumumab and Lenalidomide in Treating Participants with Minimal Residual Disease Positive Multiple Myeloma after Induction Therapy with or without High-Dose Chemotherapy with Stem Cell Support

    This phase II trial studies how well daratumumab and lenalidomide work in treating participants with minimal residual disease positive multiple myeloma after initial chemotherapy (induction therapy) with or without high-dose chemotherapy with stem cell transplant (stem cell support). Immunotherapy with daratumumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Lenalidomide works against cancer cells partly by impacting the functioning of the immune system. Giving daratumumab and lenalidomide may work better in treating participants with MRD positive multiple myeloma.
    Location: 7 locations

  • Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Treating Patients with Newly-Diagnosed Multiple Myeloma

    This phase II trial studies how well daratumumab, carfilzomib, lenalidomide, and dexamethasone work in treating patients with newly-diagnosed multiple myeloma. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving daratumumab, carfilzomib, lenalidomide, and dexamethasone may work better in treating patients with multiple myeloma.
    Location: 7 locations

  • Daratumumab in Treating Patients with High-Risk MGUS and Low-Risk Smoldering Multiple Myeloma

    This phase II trial studies how well daratumumab works in treating patients with high-risk monoclonal gammopathy of undetermined significance (MGUS) and low-risk smoldering multiple myeloma. Monoclonal antibodies, such as daratumumab, may kill or stop cancer cells from growing through a variety of mechanisms by attaching to the CD38 molecule, which is overexpressed in multiple myeloma cells.
    Location: 7 locations

  • Selinexor and Backbone Treatments of Multiple Myeloma Patients

    This study will independently assess the efficacy and safety of six combination therapies for the treatment of patients with Relapsed / Refractory Multiple Myeloma (RR MM) and Newly Diagnosed Multiple Myeloma (NDMM). The combinations to be evaluated include: selinexor + pomalidomide + dexamethasone (SPd), selinexor + bortezomib + dexamethasone (SVd), selinexor + lenalidomide + dexamethasone (SRd), selinexor + pomalidomide + dexamethasone + bortezomib (SPVd), selinexor + daratumumab + dexamethasone (SDd), and selinexor + carfilzomib + dexamethasone (SKd). The abbreviations for combination treatments have been revised to use V (Velcade) for bortezomib, R (Revlimid) for lenalidomide, D (Darzalex) for daratumumab, and K (Kyprolis) for carfilzomib.
    Location: 6 locations

  • A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Subjects With Relapsed or Refractory Multiple Myeloma

    This is a study of venetoclax, daratumumab, and dexamethasone with and without bortezomib combination therapy to evaluate safety, tolerability, and efficacy of these combinations in participants with relapsed or refractory multiple myeloma. The study will consist of 3 distinct parts: Part 1 includes participants with t(11;14) positive relapsed / refractory (R / R) multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd); Part 2 includes participants with R / R multiple myeloma who will receive venetoclax in combination with daratumumab, bortezomib, and dexamethasone (VenDVd); Part 3 includes participants with t(11;14) positive R / R multiple myeloma who will receive venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd). Part 1 and Part 2 are non-randomized and will be initiated with a dose-escalation phase in which increasing doses of venetoclax will be given with fixed doses of daratumumab and dexamethasone (Part 1a) or with fixed doses of daratumumab, bortezomib, and dexamethasone (Part 2a). Each dose escalation phase will be followed by a single-arm, open-label expansion phase. Part 3 will include a randomized, open-label expansion phase with participants receiving venetoclax in combination with daratumumab and dexamethasone (VenDd) or daratumumab, bortezomib, and dexamethasone (DVd).
    Location: 8 locations

  • Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant

    This study evaluates the use of carfilzomib, lenalidomide, daratumumab, and dexamethasone in subjects with high-risk smoldering multiple myeloma (SMM). Subjects will receive treatment in 3 phases - induction (6 cycles), consolidation (6 cycles), and maintenance (12 cycles). Each cycle is 28 days.
    Location: 6 locations

  • Dexamethasone, Lenalidomide, Carfilzomib, and Daratumumab in Treating Participants with Multiple Myeloma

    This phase II trial studies how well dexamethasone, lenalidomide, carfilzomib, and daratumumab work in treating participants with multiple myeloma. Drugs used in chemotherapy, such as dexamethasone, lenalidomide, and carfilzomib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as daratumumab, may interfere with the ability of cancer cells to grow and spread. Giving dexamethasone, lenalidomide, carfilzomib, and daratumumab may work better in treating participants with multiple myeloma.
    Location: 5 locations

  • A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Activity of Tiragolumab in Participants With Relapsed or Refractory Multiple Myeloma or With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

    This is a Phase I open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary activity of tiragolumab administered as a single agent or in combination with daratumumab or rituximab in participants with relapsed or refractory (R / R) multiple myeloma (MM) or R / R non-Hodgkin lymphoma (NHL).
    Location: 4 locations

  • Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone in Treating Patients with Multiple Myeloma That Has Come Back or Does Not Respond to Treatment

    This phase II trial studies the side effects and best dose of daratumumab, ixazomib, pomalidomide, and dexamethasone, and how well they work in treating patients with multiple myeloma that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as daratumumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pomalidomide and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving daratumumab, ixazomib, pomalidomide, and dexamethasone may work better than chemotherapy alone in treating patients with multiple myeloma.
    Location: 5 locations

  • A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

    The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.
    Location: 4 locations

  • Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients with Relapsed or Refractory Multiple Myeloma

    This phase Ib / II trial studies the side effects and best dose of carfilzomib and to see how well it works when given together with pomalidomide and dexamethasone in treating patients with multiple myeloma that has come back after a period of improvement or does not respond to treatment. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Pomalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib together with pomalidomide and dexamethasone may kill more cancer cells.
    Location: 4 locations

  • Ixazomib Citrate in Treating Patients with Relapsed Multiple Myeloma That Is Not Refractory to Bortezomib

    This randomized phase II trial studies how well ixazomib citrate works in treating patients with multiple myeloma that has returned after a period of improvement but is not resistant to bortezomib. Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: 2 locations

  • Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for the Treatment of Newly Diagnosed Multiple Myeloma in Elderly Patients

    This phase II trial studies how well daratumumab, bortezomib, lenalidomide, and dexamethasone works in treating newly diagnosed multiple myeloma in elderly patients. Immunotherapy with daratumumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as bortezomib, lenalidomide, and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving daratumumab, bortezomib, lenalidomide, and dexamethasone together may work better compared to bortezomib, lenalidomide, and dexamethasone in treating patients with multiple myeloma.
    Location: Icahn School of Medicine at Mount Sinai, New York, New York

  • Daratumumab, Ixazomib, and Dexamethasone with or without Bortezomib in Treating Patients with Newly Diagnosed Multiple Myeloma

    This phase II trial studies how well daratumumab, ixazomib, and dexamethasone with or without bortezomib work in treating patients with newly diagnosed multiple myeloma. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as ixazomib, dexamethasone, and bortezomib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving daratumumab, ixazomib, and dexamethasone with or without bortezomib may work better in treating patients with multiple myeloma.
    Location: Emory University Hospital / Winship Cancer Institute, Atlanta, Georgia

  • Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab Intravenous (Dara-IV)

    The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab intravenous (Dara-IV) to evaluate daratumumab retreatment.
    Location: 2 locations

  • INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma

    The purpose of this study is to evaluate the safety and antitumor activity of INCB001158 in combination with daratumumab SC, compared with daratumumab SC alone, in participants with relapsed or refractory multiple myeloma who have received at least 3 but not more than 5 prior lines of multiple myeloma therapy.
    Location: UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina

  • Daratumumab, Bortezomib, and Dexamethasone Followed by Daratumumab, Ixazomib, and Dexamethasone in Treating Patients with Relapsed or Refractory Multiple Myeloma

    This phase II trial studies how well daratumumab, bortezomib, and dexamethasone followed by daratumumab, ixazomib, and dexamethasone in treating patients with multiple myeloma that has come back or does not response to treatment. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib and ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving daratumumab, bortezomib, and dexamethasone followed by daratumumab, ixazomib, and dexamethasone may work better and help to control cancer in patients with multiple myeloma.
    Location: M D Anderson Cancer Center, Houston, Texas


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