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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR BORTEZOMIB

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Clinical Trials for Bortezomib

Trial ID Title Status Sponsor Phase Summary
NCT00004002 PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma Completed National Cancer Institute (NCI) Phase 1 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have advanced solid tumors or lymphoma that have not responded to previous treatment.
NCT00004002 PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma Completed New York University School of Medicine Phase 1 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have advanced solid tumors or lymphoma that have not responded to previous treatment.
NCT00005064 PS-341 in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia in Blast Phase, or Myelodysplastic Syndrome Completed National Cancer Institute (NCI) Phase 1 Phase I trial to study the effectiveness of PS-341 in treating patients who have refractory or relapsed acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia in blast phase, or myelodysplastic syndrome. PS-341 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth
NCT00006098 PS-341 in Treating Patients With Hematologic Cancer Completed National Cancer Institute (NCI) Phase 1 RATIONALE: PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have hematologic cancer.
NCT00006098 PS-341 in Treating Patients With Hematologic Cancer Completed Memorial Sloan Kettering Cancer Center Phase 1 RATIONALE: PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have hematologic cancer.
NCT00006184 Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma Completed National Cancer Institute (NCI) Phase 2 Background: The mainstay of therapy for newly diagnosed multiple myeloma patients remains systemic chemotherapy. Although partial remissions of up to 60% are obtained with conventional regimens, multiple myeloma is essentially an incurable disease with a median survival of approximately 30 months. Allogeneic stem cell transplantation (SCT) results in a high percentage of complete remissions, but it can be associated with significant treatment-related mortality, which has been primarily attributed to conventional myeloablative transplant regimens. Recent clinical studies have shown that highly immunosuppressive yet non-myeloablative doses of fludarabine-based chemotherapy can result in alloengraftment. Even with a reduction in treatment related mortality, success with allogeneic SCT is limited by a significant risk of relapse. Donor immunization with myeloma Id in the setting of a non-myeloablative allogeneic SCT may represent a novel strategy for the treatment of multiple myeloma. Objectives: Primary Objectives: To induce cellular and humoral immunity in allogeneic stem cell donors and recipients against the unique idiotype expressed by the recipient's myeloma. To determine whether antigen-specific immunity, induced in the stem cell donor, can be passively transferred to the allogeneic SCT recipient in the setting of a non-myeloablative conditioning regimen. Secondary Objectives: To evaluate the effect of the Fludarabine-(etoposide, doxorubicin, vincristine, prednisone, cyclophosphamide) EPOCH regimen on host T cell depletion and myeloid depletion prior to allogeneic SCT. To determine the efficacy of a novel conventional chemotherapy regimen (Fludarabine-EPOCH) in the setting multiple myeloma. To determine the treatment-related morbidity and mortality of allogeneic stem cell transplantation using a non-myeloablative conditioning regimen in multiple myeloma. To determine if the re-vaccination of allogeneic stem cell donors with the unique idiotype expressed by the recipient's myeloma will enhance cellular and humoral immunity to patient specific-idiotype prior to lymphocyte donation for the treatment of patients with recurrent or progressive disease after transplantation. Eligibility: Patients 18-75 years of age with Immunoglobulin G (IgG) or Immunoglobulin A (IgA) multiple myeloma. Patients must have achieved at least a partial remission following initial conventional chemotherapy regimen or after autologous stem cell transplantation. Consenting first degree relative matched at 6/6 or 5/6 human leukocyte antigen (HLA) antigens. Design: Phase 2 trial using a non-myeloablative conditioning regimen to reduce treatment-related toxicity. Recipient will undergo a plasmapheresis to obtain starting material for the isolation of idiotype protein. Donors would be immunized with an Id vaccine prepared from the patient. Prior to transplantation patients would receive a conventional chemotherapy regimen which contains agents active in myeloma and is T cell depleting. The allogeneic SCT would be performed with a conditioning regimen consisting of cyclophosphamide and fludarabine. The stem cell source would be blood mobilized with filgrastim. Recipients will be immunized with the Id vaccine following transplantation.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Bortezomib

Condition Name

Condition Name for Bortezomib
Intervention Trials
Multiple Myeloma 323
Lymphoma 49
Multiple Myeloma and Plasma Cell Neoplasm 26
Mantle Cell Lymphoma 25
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Condition MeSH

Condition MeSH for Bortezomib
Intervention Trials
Multiple Myeloma 434
Neoplasms, Plasma Cell 415
Lymphoma 147
Leukemia 65
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Clinical Trial Locations for Bortezomib

Trials by Country

Trials by Country for Bortezomib
Location Trials
Germany 97
United Kingdom 96
France 76
Japan 72
Australia 48
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Trials by US State

Trials by US State for Bortezomib
Location Trials
California 141
New York 128
Texas 107
Massachusetts 104
Florida 99
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Clinical Trial Progress for Bortezomib

Clinical Trial Phase

Clinical Trial Phase for Bortezomib
Clinical Trial Phase Trials
Phase 4 23
Phase 3 85
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Bortezomib
Clinical Trial Phase Trials
Completed 341
Recruiting 158
Active, not recruiting 122
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Clinical Trial Sponsors for Bortezomib

Sponsor Name

Sponsor Name for Bortezomib
Sponsor Trials
National Cancer Institute (NCI) 198
Millennium Pharmaceuticals, Inc. 126
Celgene Corporation 35
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Sponsor Type

Sponsor Type for Bortezomib
Sponsor Trials
Other 842
Industry 488
NIH 208
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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Colorcon
US Department of Justice
Cerilliant
Cantor Fitzgerald
Johnson and Johnson
Healthtrust
Medtronic
Express Scripts

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