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 56
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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: 547 locations

  • Efficacy and Safety Study of bb2121 Versus Standard 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 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: 29 locations

  • A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant

    The purpose of this study is to evaluate conversion rate to minimal residual disease (MRD) negativity following the addition of daratumumab to lenalidomide relative to lenalidomide alone, when administered as maintenance treatment to anti-cluster of differentiation 38 (CD38) treatment naive participants with newly diagnosed multiple myeloma who are MRD positive as determined by next generation sequencing (NGS) following high-dose therapy (HDT) and autologous stem cell transplant (ASCT), with or without consolidation therapy.
    Location: 21 locations

  • A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma

    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 monotherapy, 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 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.
    Location: 18 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, 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. Anti-inflammatory drugs, such as dexamethasone lower the body’s immune response and are used with other drugs in the treatment of some types of cancer. 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 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: 16 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: 11 locations

  • A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma

    The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.
    Location: 9 locations

  • A Study to Determine the Recommended Dose and Regimen and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

    This is an open-label, multicenter, Phase 1 / 2 study to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D), and to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.
    Location: 10 locations

  • A Study of Health-Related Quality of Life in Patients with Multiple Myeloma Receiving Daratumumab or Lenalidomide

    This phase II trial compares daratumumab and lenalidomide as maintenance therapy in treating patients with multiple myeloma. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Monoclonal antibodies target and destroy only certain cells in the body. This selective targeting may help protect healthy cells from damage. Lenalidomide is an immunomodulatory drug that works against cancer cells by helping to change or control the functioning of the immune system. This trial is being done to compare the usual maintenance therapy (lenalidomide) versus daratumumab as maintenance therapy, to see if one is better than the other, how they affect multiple myeloma, which drug gives patients a better health-related quality of life during treatment, and if one is easier to take than the other.
    Location: 7 locations

  • Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone for the Treatment of Newly Diagnosed Multiple Myeloma

    This phase II trial compares the safety and activity of the combination of carfilzomib, lenalidomide, and dexamethasone (KRD), or carfilzomib, lenalidomide, dexamethasone and daratumumab (KRD+DARA) with the usual treatment composed of lenalidomide, bortezomib and dexamethasone (VRD) for the treatment of newly diagnosed multiple myeloma. Immunotherapy with daratumumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Carfilzomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that tumors need to grow. Anti-inflammatory drugs such as dexamethasone lower the body’s immune response and are used with other drugs in the treatment of some types of cancer. This study will measure the amount of myeloma cells that remain in the body after treatment with the study drugs, described as minimal residual disease (MRD). Studies show that having no remaining multiple myeloma cells or a low number of these cells (MRD negativity) is associated with better clinical outcomes. This study compares the results of the usual treatment (VRD) with those of KRD or KRD+DARA to see which treatment is safer and results in more patients achieving MRD negativity.
    Location: 7 locations

  • Daratumumab and Lenalidomide in Treating Patients 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 patients 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 patients with MRD positive multiple myeloma.
    Location: 7 locations

  • Selinexor and Backbone Treatments of Multiple Myeloma Patients

    This study will independently assess the efficacy and safety of 8 combination therapies in 9 arms, in dose-escalation / -evaluation and expansion phases, for the treatment of patients with relapsed / refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM). The combinations to be evaluated are: - Arm 1: Selinexor + dexamethasone + pomalidomide (SPd) - Arm 2: Selinexor + dexamethasone + bortezomib (SVd); enrollment complete - Arm 3: Selinexor + dexamethasone + lenalidomide (SRd) in RRMM; enrollment complete - Arm 4: Selinexor + dexamethasone + pomalidomide + bortezomib (SPVd) - Arm 5: Selinexor + dexamethasone + daratumumab (SDd); enrollment complete - Arm 6: Selinexor + dexamethasone + carfilzomib (SKd) - Arm 7: Selinexor + dexamethasone + lenalidomide (SRd) in NDMM - Arm 8: Selinexor + dexamethasone + ixazomib (SNd) - Arm 9: Selinexor + dexamethasone + pomalidomide + elotuzumab (SPEd) Selinexor pharmacokinetics: - PK Run-in (Days 1-14): Starting in protocol version 8.0, patients enrolled to any arm in the Dose Escalation Phase (i.e., Arm 4 SPVd, Arm 6 SKd, Arm 8 SNd, Arm 9 SPEd) will also first be enrolled to a pharmacokinetics (PK) Run-in period until 9 patients have been enrolled to this period to evaluate the PK of selinexor before and after co-administration with a strong CYP3A4 inhibitor.
    Location: 7 locations

  • NKTR-255 in Relapsed / Refractory Multiple Myeloma & Non-Hodgkin Lymphoma

    Patients will receive intravenous NKTR-255 in 21-day treatment cycles. During the Part 1 dose escalation portion of the trial, NKTR-255 will be given as monotherapy. After determination of the recommended Phase 2 dose (RP2D) of NKTR-255, NKTR-255 will be evaluated in 3 expansion Cohorts in Part 2. Cohort A will enroll Non-Hodgkin Lymphoma (NHL) patients that have relapsed after CAR-T therapy. Cohort B will enroll patients with relapsed / refractory Multiple Myeloma (MM). Cohort C will enroll patients with relapsed / refractory indolent Non-Hodgkin Lymphoma (iNHL). This is a Phase 1 study to evaluate safety and tolerability of NKTR-255 alone and in combination with daratumumab or rituximab.
    Location: 9 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

  • Daratumumab, Carfilzomib, Pomalidomide, and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma

    This phase II trial studies the side effects of daratumumab and how well it works in combination with carfilzomib, pomalidomide, and dexamethasone in treating patients with multiple myeloma that has come back (relapsed) or does not respond to treatment (refractory). Daratumumab is a type of antibody (a protein that attaches to other cells to fight off infection) that works by attaching to the CD38 molecule which is expressed in multiple myeloma cells. By attaching to the CD38 molecule, daratumumab may cause cell death. Carfilzomib is a type of inhibitor that works by inhibiting (blocking) multiple myeloma cells from breaking down proteins within the cells. This may cause a buildup of proteins within multiple myeloma cells, which may lead to cell death. Pomalidomide is an immunomodulatory drug (it affects the immune system) that works by affecting the growth signals that keep cancer cells alive. Dexamethasone is a corticosteroid (a type of steroid) that may kill cancer cells. Giving daratumumab in combination with carfilzomib, pomalidomide, and dexamethasone may kill more cancer cells in patients with multiple myeloma.
    Location: 4 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

  • 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.
    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 of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma

    The purpose of this study is to identify recommended Phase 2 doses (RP2Ds) for each treatment combination (between daratumumab plus talquetamab and teclistamab plus daratumumab) and to characterize the safety of each RP2D for selected treatment combinations.
    Location: 5 locations

  • 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: 3 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


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