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Last Updated: January 27, 2020

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CLINICAL TRIALS PROFILE FOR DEXAMETHASONE

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505(b)(2) Clinical Trials for Dexamethasone

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00116961 Velcade, Doxil, and Dexamethasone (VDd) as First Line Therapy for Multiple Myeloma Completed University of Michigan Cancer Center Phase 2 2005-06-01 This is a research study for patients with newly diagnosed multiple myeloma. Multiple myeloma remains a non-curable disease however, newer medications and their combinations appear to provide higher response rates and higher complete response rates than current treatment options. One of the new medications in multiple myeloma is Velcade. Preliminary results from a study using a combination of Velcade with Doxil have shown high response rates (disease reduction). Preliminary results also show that an addition of dexamethasone to Velcade in patients not responding to Velcade alone showed improved response rates. This study involves treatment with a new combination of three standard medications: Velcade, Doxil, and dexamethasone (VDd combination). The proposed combination of all three drugs may improve efficacy and response. Velcade is approved by the Food and Drug Administration (FDA) for treatment in multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Velcade is still currently under investigation for other indications. Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients with some other cancers. Several published clinical trials provide evidence that Doxil is an active agent in multiple myeloma and it is used in treatment combinations for multiple myeloma in general practice. Dexamethasone is a standard therapy for multiple myeloma, but is not approved by the FDA for that use. The combination of all three drugs is experimental (not FDA approved). The goals of this study are to determine if this new combination therapy with Velcade, Doxil and dexamethasone is an effective treatment and also to determine the side effects that occur when this combination treatment is given.
New Combination NCT00135187 Study of Combination Therapy With VELCADE, Doxil, and Dexamethasone (VDd) in Multiple Myeloma Completed University of Michigan Cancer Center N/A 2004-07-01 Patients are being asked to take part in this research study because they have multiple myeloma which has relapsed after (come back), or is refractory to (unaffected by), initial therapy. For patients who have relapsed or are refractory to therapy, there is no agreed upon standard treatment. Treatment options include chemotherapy and, for some patients, bone marrow transplants. None of the available treatments are curative and investigators are continually looking for more effective treatments. This study involves treatment with a new combination of standard drugs: VELCADE, Doxil, and Dexamethasone. Preliminary results from a study using a combination of VELCADE with Doxil showed high response rates (disease reduction). Two other studies showed that an addition of Dexamethasone to VELCADE in patients not responding to VELCADE alone improved response rate. The proposed combination of all three drugs may improve efficacy and response. VELCADE is approved by the Food and Drug Administration (FDA) for use in multiple myeloma. Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients with some other cancers. Several published clinical trials provide evidence that Doxil is an active agent in multiple myeloma and it is used in treatment combinations for multiple myeloma in general practice. Dexamethasone is approved for use in multiple myeloma. The combination of all three drugs is experimental (not FDA approved). The goals of this study are to determine if this new combination therapy with VELCADE, Doxil and Dexamethasone is an effective treatment, and also to determine the side effects that occur when this combination treatment is given.
New Combination NCT00209495 Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients Completed Glostrup University Hospital, Copenhagen Phase 4 2005-06-01 Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine. Unfortunately morphine has side-effect: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine.
New Combination NCT00235261 Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients After Hip Operations Completed Glostrup University Hospital, Copenhagen Phase 4 2005-10-01 Patients scheduled for primary total hip replacement needs postoperative pain treatment: i.e. morphine. Unfortunately morphine has side-effects: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine and improve the patients pain score after operation.
New Combination NCT00236223 The Effect of Gabapentin, Ketamine and Dexamethasone on Pain and Opioid Requirements After Hip Surgery Terminated Glostrup University Hospital, Copenhagen Phase 4 2005-10-01 Patients scheduled for primary hip replacement needs postoperative pain treatment, i.e. morphine. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These side-effects are unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine.
New Combination NCT00378547 Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Having a Tonsillectomy Terminated Glostrup University Hospital, Copenhagen Phase 4 2006-01-01 Patients scheduled for a tonsillectomy need postoperative pain treatment. Some of the most widely used postoperative analgetics (NSAIDs) sometimes cause rebleeding in the postoperative period, and another often used analgetic, morphine, causes nausea and vomiting. The researchers therefore will investigate new combinations of postoperative analgesics in hopes of improving pain and the need for opioids during the postoperative period.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Dexamethasone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000563 Prevention of Neonatal Respiratory Distress Syndrome With Antenatal Steroid Administration Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1976-06-01 To determine the effect of corticosteroids, administered 24 to 48 hours before parturition, on the incidence of neonatal respiratory distress syndrome (RDS) and to determine whether the therapy has any adverse short- or long-term (up to 36 months) effects on the infant. Secondarily, to determine whether the therapy has any adverse short-term effects on the mother and to determine whether morbidity rates for neonatal respiratory distress syndrome as well as total and cause-specific infant mortality rates differ between mothers who received antenatal steroids and those who received conventional medical care.
NCT00000621 Feasibility of Retinoic Acid Treatment in Emphysema (FORTE) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1999-09-01 To conduct feasibility studies on the use of retinoids in the treatment of emphysema. Specific objectives are to identify optimal patient populations, retinoids, doses, dosing schedules, routes of administration, and outcome measures preparatory to conducting a larger, controlled, clinical trial on the efficacy of retinoid therapy in the management of emphysema.
NCT00000658 A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma Completed Schering-Plough Phase 3 1969-12-31 To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
NCT00000658 A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1969-12-31 To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
NCT00000689 Phase I Trial of mBACOD and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in AIDS-Associated Large Cell, Immunoblastic, and Small Non-cleaved Lymphoma Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To determine the toxicity and effectiveness of adding sargramostim (recombinant granulocyte-macrophage colony stimulating factor; GM-CSF) to a standard chemotherapy drug combination (methotrexate, bleomycin, doxorubicin, cyclophosphamide, vincristine, and dexamethasone) known as mBACOD in the treatment of non-Hodgkin's lymphoma in patients who are infected with HIV. Treatment of patients with AIDS-associated lymphoma is achieving inferior results when compared with outcomes for non-AIDS patients. Treatment with mBACOD has been promising, but the toxicity is very high. Patients treated with mBACOD have very low white blood cell counts. GM-CSF has increased the number of white blood cells in animal studies and preliminary human studies. It is hoped that including GM-CSF among the drugs given to lymphoma patients will prevent or lessen the decrease in white blood cells caused by mBACOD.
NCT00000703 Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To determine the safety and effectiveness of a combination chemotherapy-radiation-zidovudine (AZT) treatment for patients with peripheral lymphoma. Other chemotherapies have been tried in patients with AIDS related lymphomas, but the results have not been satisfactory. This study will show whether the combination of chemotherapy, radiation, and AZT is more effective and less toxic than previously used treatments.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dexamethasone

Condition Name

Condition Name for Dexamethasone
Intervention Trials
Multiple Myeloma 485
Leukemia 89
Lymphoma 81
Postoperative Pain 51
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Condition MeSH

Condition MeSH for Dexamethasone
Intervention Trials
Multiple Myeloma 705
Neoplasms, Plasma Cell 680
Lymphoma 226
Leukemia 211
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Clinical Trial Locations for Dexamethasone

Trials by Country

Trials by Country for Dexamethasone
Location Trials
Canada 547
Netherlands 92
Belgium 77
Denmark 71
Brazil 69
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Trials by US State

Trials by US State for Dexamethasone
Location Trials
Texas 327
New York 313
California 297
Massachusetts 243
Florida 212
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Clinical Trial Progress for Dexamethasone

Clinical Trial Phase

Clinical Trial Phase for Dexamethasone
Clinical Trial Phase Trials
Phase 4 354
Phase 3 470
Phase 2/Phase 3 48
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Clinical Trial Status

Clinical Trial Status for Dexamethasone
Clinical Trial Phase Trials
Completed 806
Recruiting 600
Not yet recruiting 368
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Clinical Trial Sponsors for Dexamethasone

Sponsor Name

Sponsor Name for Dexamethasone
Sponsor Trials
National Cancer Institute (NCI) 260
M.D. Anderson Cancer Center 126
Celgene Corporation 117
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Sponsor Type

Sponsor Type for Dexamethasone
Sponsor Trials
Other 2719
Industry 1063
NIH 318
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