Clinical Trials Using Bortezomib

Clinical trials are research studies that involve people. The clinical trials on this list are studying Bortezomib. 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 37
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  • Testing the Use of Combination Therapy in Adult Patients with Newly Diagnosed Multiple Myeloma, the EQUATE Trial

    This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three-drug combination (daratumumab, lenalidomide and dexamethasone) in patients with newly diagnosed multiple myeloma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, 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. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. 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. Adding bortezomib to daratumumab, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on a combination of daratumumab, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma.
    Location: 45 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

  • Bortezomib, Vorinostat, and Combination Chemotherapy in Treating Infants with Newly Diagnosed Acute Lymphoblastic Leukemia

    This phase I / II trial studies the side effects and best dose of vorinostat and to see how well it works when given together with bortezomib and combination chemotherapy in treating infants (patients less than 1 year old) with newly diagnosed acute lymphoblastic leukemia. Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as methotrexate, hydrocortisone, and cytarabine, 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 more than one drug (combination chemotherapy) with bortezomib and vorinostat may be a better treatment for acute lymphoblastic leukemia.
    Location: 11 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

  • Duvelisib and Romidepsin or Bortezomib in Treating Patients with Relapsed or Refractory T-cell Lymphoma

    This phase I trial studies the side effects and best dose of duvelisib when given together with romidepsin or bortezomib in treating patients with T-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Duvelisib, romidepsin, and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: 10 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: 10 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

  • 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

  • To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed / Refractory Multiple Myeloma (RRMM)

    This study will evaluate the safety and tolerability profile of belantamab mafodotin when administered in combination with approved regimens of either Lenalidomide Plus Dexamethasone [Len / Dex (Arm A)] or Bortezomib Plus Dexamethasone [Bor / Dex (Arm B)] in participants with RRMM, i.e., those who have relapsed or who are refractory to at least 1 line of approved therapy. Part 1 of the study will be a dose escalation phase to evaluate the safety and tolerability of up to 3 dose levels and up to 2 dosing schedules of belantamab mafodotin in combination with the two standard of care (SoC) regimens. Part 2 will further evaluate the safety and preliminary clinical activity of belantamab mafodotin at selected dose levels and dosing schedules in combination with Len / Dex or Bor / Dex. A total of 152 evaluable participants will be enrolled in the study with up to 27 in Part 1 and up to 125 in Part 2. Participants receiving treatment Arm A, may continue combination treatment until the occurrence of progressive disease (PD), intolerable adverse events (AEs ), consent withdrawal, death or end of study. The participants receiving treatment Arm B, may continue combination treatment for a total of up to 8 cycles. After 8 cycles of combination therapy, the participants will continue treatment with belantamab mafodotin, as a monotherapy until the occurrence of PD, intolerable AEs, consent withdrawal, death or end of study.
    Location: 7 locations

  • Selinexor and Backbone Treatments of Multiple Myeloma Patients

    This study will independently assess the efficacy and safety of 10 combination therapies in 11 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) - Arm 10: Selinexor + dexamethasone + belantamab mafodotin (SBd) - Arm 11: Selinexor + dexamethasone + pomalidomide + daratumumab (SDPd) 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], Arm 10 [SBd], and Arm 11 [SDPd]) 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

  • 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

  • Combination Chemotherapy in Treating Patients with Acute Lymphoblastic Leukemia or Lymphoma

    This randomized phase II / III trial studies the side effects of combination chemotherapy and how well it works in treating patients with acute lymphoblastic leukemia or lymphoma. Drugs used in combination chemotherapy 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.
    Location: 5 locations

  • Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed / Refractory Multiple Myeloma

    This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib / dexamethasone (Arm A) versus daratumumab in combination with bortezomib / dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.
    Location: 5 locations

  • A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)

    The purpose of this study is to determine the recommended phase 2 dose (RP2D) of TAK-079 when administered to participants with NDMM in combination with the backbone treatment regimen.
    Location: 3 locations

  • A Study to Evaluate the Effectiveness and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis

    AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine if CAEL-101 improves the overall survival in Patients with cardiac AL Amyloidosis.
    Location: 7 locations

  • A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma

    The purpose of this study is to compare the efficacy of JNJ-68284528 with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).
    Location: 5 locations

  • Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity

    This study will gain information about a rare disorder called KSHV-associated multicentric Castleman s disease (MCD). KSHV, a virus, causes several kinds of cancer, including some forms of MCD. KSHV stands for the Kaposi s sarcoma herpes virus, also called human herpes virus-8, or HHV-8. Researchers want to understand the biology of KSHV-MCD to identify how this disease causes illness and to find ways to treat it. There is no standard therapy effective for all cases of KSHV-MCD. The disease is often fatal, and about half the people who have it die within 2 years of diagnosis. Patients ages 12 and older may be eligible for this study. Participation entails more drawing of blood and having repeated tumor biopsies than if patients received treatment in a non-research setting. Researchers would like to learn more about the relationship of KSHV and Castleman s disease symptoms, and they want to obtain at least three biopsies in this study. There are some side effects of experimental therapy that patients may take for KSHV-MCD. Zidovudine, or Retrovir , is used at a high dose. It is given orally or through a vein, four times daily, for 7 days or longer. Zidovudine can cause nausea, vomiting, decreased bone marrow function, and decreased blood counts. Combined with valganciclovir, or Valcyte , it is likely to be more toxic to bone marrow. Valganciclovir can cause problems with bone marrow function, leading to low blood counts, sterility, and defects in a fetus. Combined with zidovudine, valganciclovir may cause more toxicity to the bone marrow. It is given twice daily for 7 days or longer. Bortezomib, or Velcade , is given for a few seconds by a rapid push through a needle into the vein. It is given twice weekly for four doses and then stopped for 1 week. Bortezomib can sometimes cause low blood pressure; it also can cause gastrointestinal problems and a low blood platelet count. Rituximab and liposomal doxorubicin are drugs given by a catheter into a vein. Interferon-alpha is given by injection into the skin. Those drugs are not experimental, but their use in Castleman s disease is experimental. Some patients may be treated with a combination of chemotherapy followed by interferon-alpha. Interferon-alpha is infected into the skin by a needle. The natural form of interferon is produced by the body and helps to control viral infections. KSHV decreases the effect of the body s interferon, and the researchers want to see if giving higher doses of interferon will help to control KSHV infection. A positron emission tomography (PET) scan, for research purposes only, may be done up to three times a year. A radioactive sugar molecule called fluorodeoxyglucose, or FDG, is used. It is believed that activated lymphocytes that may be found in patients disease might use more FDG because these cells burn more glucose fuel. Children younger than 18 years will not have PET scan done. This study may or may not have a direct benefit for participants. However, detailed assessments made throughout the study may provide information to help the doctors treat KSHV-MCD better. ...
    Location: 2 locations

  • A Study to Evaluate the Effectiveness and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis

    AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine if CAEL-101 improves the overall survival in Patients with cardiac AL Amyloidosis.
    Location: 7 locations

  • Daratumumab-Based Therapy for the Treatment of Newly Diagnosed Multiple Myeloma with Kidney Failure

    This phase II trial studies how well daratumumab-based therapy works in treating patients with newly diagnosed multiple myeloma with kidney failure. Daratumumab-based therapy includes daratumumab, bortezomib, dexamethasone, and thalidomide or lenalidomide. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Bortezomib is a drug that prevents myeloma cells from getting rid of their waste products, leading to being targeted for death. Dexamethasone is a steroid that is commonly used, either alone or in combination with other drugs, to treat multiple myeloma. Lenalidomide and thalidomide may stop the growth of multiple myeloma by blocking the growth of new blood vessels necessary for tumor growth. Giving daratumumab, bortezomib, dexamethasone, and thalidomide or lenalidomide may be a good way to treat patients with newly diagnosed multiple myeloma with kidney failure.
    Location: Emory University Hospital / Winship Cancer Institute, Atlanta, Georgia

  • Daratumumab and Dexamethasone with or without Lenalidomide or Bortezomib for the Treatment of Newly Diagnosed Multiple Myeloma in Older Adults

    This phase II trial studies how well daratumumab and dexamethasone with or without lenalidomide or bortezomib works in treating older adults 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 dexamethasone, lenalidomide, 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. Giving daratumumab and dexamethasone with lenalidomide or bortezomib may work better in treating older adults with multiple myeloma compared to daratumumab and dexamethasone.
    Location: Moffitt Cancer Center, Tampa, Florida

  • Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma

    This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule. Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. This will be every cycle of VRd, every other cycle of VRd, or every third cycle of VRd. Belantamab may also be given as a 'split' dose, which is 50% of the dose on Day 1 and 50% of the dose on Day 8 of a cycle. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.
    Location: 3 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. Daratumumab is a monoclonal antibody that may induce changes in body’s immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bortezomib and lenalidomide, 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. 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. 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

  • Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

    This phase Ib trial determines if samples from a patient’s cancer can be tested to find combinations of drugs that provide clinical benefit for the kind of cancer the patient has. This study is also being done to understand why cancer drugs can stop working and how different cancers in different people respond to different types of therapy.
    Location: OHSU Knight Cancer Institute, Portland, Oregon

  • Metformin, Nelfinavir, and Bortezomib in Treating Patients with Relapsed and / or Refractory Multiple Myeloma

    This phase I trial studies the side effects and best dose of metformin and nelfinavir in combination with bortezomib in treating patients with multiple myeloma that has come back or does not respond to treatment. Metformin may stop the growth of tumor cells by disrupting the energy source within multiple myeloma cells. Nelfinavir and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving metformin, nelfinavir, and bortezomib may work better in treating patients with multiple myeloma.
    Location: Mayo Clinic in Rochester, Rochester, Minnesota


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