View clinical trials related to Neoplasms, Plasma Cell.
Filter by:The purpose of the study in Phase I is to select the recommended dose of bortezomib in combination with melphalan and prednisolone in Japanese participants. In Phase II, to assess the effectiveness and safety of the recommended dose of bortezomib (selected in the phase I portion).
The median overall survival (OS) of relapsed/refractory multiple myeloma (MM) is less than nine months. However, phase II data with the proteasome inhibitor bortezomib (Velcade®) has been heartening, with 35% overall response rates and median survival of 16 months. In-vitro data has shown that this agent dramatically increases the sensitivity to chemotherapeutic agents. Liposomal doxorubicin (Doxil), melphalan, and bortezomib all have different mechanisms of action and toxicity profiles. Clinical studies employing two drug combinations with these agents in patients with refractory MM have found favorable efficacy (nearly no progression of disease) and tolerance data. Thus, the investigators are initiating a phase I/II study to examine the safety and efficacy of combining all three agents into the regimen DMV (Doxil® + melphalan + Velcade).
The is a randomized control study for newly-diagnosed myeloma patients 18-65 year old. All patients will receive 4 cycles of velcade and Dexamethasone as front-line therapy. Then patients will be randomized into standard group which will receive a single autologous hematopoietic stem cell transplantation with standard conditioning of melphalan 200mg/m2 and the study group which will receive single autologous hematopoietic stem cell transplantation with conditioning of melphalan 200mg/m2 + velcade followed by 3 more cycles of velcade alone as consolidation.
Background: - Allogeneic hematopoietic stem cell transplantation (allotransplant) has been used to treat many kinds of cancer that develop in cells from the blood or immune system. After allotransplant, donor cells take over production of the recipient s blood and immune cells, and donor immune cells can directly attack and control tumor. However, for cancers that do not respond to allotransplant, there are no proven cures. - A single treatment with radiation can improve the potency of immune-cell therapies. This is probably because the tumor tissue is damaged in a way that new tumor proteins are exposed, attracting immune cells to the tumor. By giving only a single dose of radiation, the immune cells that are attracted to the tumor are allowed to survive and function in their usual way, traveling throughout the body and educating other immune cells to recognize tumor, and to activate and expand in order to kill the tumor cells. Some research has shown that radiation may have a widespread effect on stimulating the immune system, educating immune cells to recognize and control tumors that have not been radiated. Objectives: - To determine whether a single treatment of radiation will help donor immune cells control cancer after allotransplant without causing excessive side effects. Eligibility: - Recipients: Individuals 18 years of age and older who have blood cancers that have not responded to allotransplant. - Donors: Healthy individuals 18 years of age and older who were previous allotransplant donors for one of the study recipients. Design: - Donors will provide additional blood immune cells, called lymphocytes, through apheresis. Apheresis involves drawing blood, separating out the lymphocytes, and returning the rest of the blood to the donor. - Recipients will receive a single dose of radiation to the greatest amount of tumor that can be irradiated safely. Researchers will intentionally leave some tumor that will not be radiated in order to evaluate whether there is a widespread response to the treatment. - There are two treatment arms on the study. - Arm 1: Study participants who have donor lymphocytes available and who have not had major complications from the allotransplant will be given a dose of donor cells after they receive radiation, to provide an additional boost to the donor immune response. - Arm 2: Study participants who cannot receive donor lymphocytes because their donor is not available, they received an allotransplant from a partially matched relative, or they have had significant complications from the allotransplant - will receive radiation without additional donor lymphocytes. - All recipients will be followed closely for side effects and for tumor response to radiation with or without donor lymphocytes. Additional tests will be performed, including tumor biopsies, bone marrow samples, and blood draws, in order to study the immune effects of radiation and donor lymphocytes. - A separate, control group of allotransplant recipients will not receive radiation. This group will include participants whose transplant doctors plan to use donor lymphocyte therapy alone to control cancer progression. This group will donate blood immune cells through blood draws and apheresis. These cells will be examined to study the immune effects of receiving donor lymphocytes without radiation.
OBJECTIVES - Primary: To evaluate the bone anabolic effect of bortezomib in patients with smoldering myeloma. - Secondary: To evaluate the effect of bortezomib on the natural history of smoldering myeloma.
The aim of this study is to evaluate the effect of bortezomib in combination with dexamethasone and zoledronic acid on bone mineral density (BMD) and skeletal related events (SREs) in Patients with Multiple Myeloma who Have Relapsed after 1-3 Prior Lines of Therapy
The purpose of this study is to test the effect of the combination of bortezomib and tipifarnib. Bortezomib (VELCADE) is approved by the Food and Drug Administration (FDA) for the treatment of multiple myeloma patients who have received at least one prior therapy. Tipifarnib is not yet approved by the FDA and is an investigational drug. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. Because these drugs have not been used together before, it is not clear which dose of each agent is optimal when used in combination. This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drugs to use for further studies. The investigators will test the safety of BORTEZOMIB and TIPIFARNIB together and see what effects (good and bad) it has on you and your MULTIPLE MYELOMA, and to find the highest dose of both agents that can be given without causing severe side effects.
Extract from the mushroom Agaricus blazei Murill har been shown to have strong immunomodulating properties both in cell cultures, animal models and in humans. Furthermore antitumor properties have been shown in animal models, among them in mice with multiple myeloma. The investigators now want to investigate the effect of Agaricus as supplementary treatment in addition to chemotherapy in patients with multiple myeloma.
The goal of this clinical research study is to learn if cleaning the stem cells of a patient who has multiple myeloma (MM) with the bone marrow of a relative will make a cell product capable of replacing the bone marrow after standard treatment with chemotherapy.
This phase I/II trial studies the best dose and side effects of lenalidomide and thalidomide, and how well they work with dexamethasone in treating participants with multiple myeloma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as lenalidomide, thalidomide 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.