View clinical trials related to Multiple Myeloma.
Filter by:This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells. Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.
The goal of this study is to gain new knowledge about genetic risk factors thta may affect the development of mucositis, the chemotherapy-induced sores in the mouth and esophagus following HSCT. The study seeks to understand if different forms of genes result in an increased risk of sores in the mouth and esophagus.
Background: - Carfilzomib is an experimental anti-cancer drug that has not yet been approved for treating multiple myeloma. Lenalidomide is a drug that may stop tumor growth and help the immune system kill cancer cells. Dexamethasone is a drug that helps stop inflammation. It is sometimes used to treat (alone or with other drugs) certain types of cancer, especially multiple myeloma. This combination of drugs has not been tested in people with multiple myeloma. Researchers want to see whether it is safe and effective for this group. Objectives: - To test the effectiveness of combined carfilzomib, lenalidomide, and dexamethasone in treating multiple myeloma. Eligibility: - People at least 18 years of age who have multiple myeloma that has not been treated. Design: - Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, a bone marrow sample, and molecular imaging studies. - Participants will have eight 28-day cycles of treatment. The combined study drugs will be given as tablets and injections. Those in the study will be monitored with frequent blood tests, bone marrow samples, and molecular imaging studies. In addition to current standard measures to determine clinical responses, molecular tests will be conducted to define evidence of minimal residual disease. - After the first four cycles of therapy, those who are eligible for a stem cell transplant will have stem cells collected and stored for use if the cancer returns. - After stem cell collection, participants will have the second four treatment cycles. -, If the disease has improved or is stable at the end of eight cycles, those in the study may have another 12 cycles of low-dose (maintenance) lenalidomide alone. - Participants will have regular follow-up visits after the end of the study chemotherapy.
Primary objective 1) To assess whether oncologic and hematologic patients develop a protective immunological response after pandemic Influenza A (H1N1) vaccine Secondary objectives 1. To compare the levels of antibody response against A (H1N1) influenza virus between oncologic and hematologic patients relative to a cohort of healthy volunteers 2. To assess the incidence of A (H1N1) infection in vaccinated oncologic and hematologic patients in comparison with a cohort of vaccinated healthy volunteers. To assess the clinical symptoms attributable to influenza infection in vaccinated oncologic and hematological patients and healthy volunteers. 3. To compare the levels of antibody response against A (H1N1) influenza virus between the following subgroups: patients with ongoing chemotherapy; patients who have completed the chemotherapy treatment; patients treated with autologous or allogeneic peripheral blood hematopoietic stem cell transplant (PBSCT) Study procedures: Onco-hematological patients will perform a blood sample collection before the vaccination, on day +21 after vaccination , on day +50 and on day +90. At the end of the collection, the investigators will perform immunological test to evaluate the antibody titer and the cellular response. The titer of antibodies against the vaccine strain will be measured in all samples by hemagglutination-inhibition (HI) assays with the use of turkey erythrocytes and according to EMEA guidelines. Response criteria will be the achievement of a protective title of HI test > 1:40. In addition, the investigators will evaluate: geometric mean titers and a fourfold titer increase compared with prevaccination titers. Cellular-mediated response will be analysed by flow-cytometry. A control cohort of healthy volunteers who received A(H1N1) vaccine will perform the same blood sample collection. Evaluation of clinical response: Oncologic and hematologic patients will be followed as outpatients or inpatients according to routine controls for their disease. In case that symptoms of the upper airways or influenza-like symptoms develop, the symptoms will be recorded in the clinical database, nasal and pharyngeal swaps will be performed according to the doctor who is taking care of the patient. In order to evaluate the clinical efficacy of the vaccination, the swaps will be tested for A (H1N1) influenza virus infection. No further studies will be performed after 3 months from the vaccination.
Primary objective of the study is the determination of the maximum tolerated dose (MTD) of Vorinostat (V), given in combination with fixed doses of Doxorubicin (D), Bortezomib (B) and Dexamethasone (D). Secondary objectives are: Assessment of safety and tolerability of VBDD; efficacy data of VBDD.
The purpose of this research study is to compare the survival rates of patients with better risk disease undergoing hematopoietic stem cell transplant (HSCT) to the survival rates reported in the medical literature of similar patients undergoing reduced intensity HSCT from matched related donors.
The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) in phase 1 and to determine the combined response rate of clinical response CR and very good partial response (VGPR) in phase 2 of oral (PO) ixazomib administered twice-weekly in combination with lenalidomide and low-dose dexamethasone in a 21-day cycle in participants with newly diagnosed multiple myeloma (NDDM).
The goal of this clinical trial is to determine the toxicity and also the efficacy of a treatment that includes the following treatment: Two medications, bortezomib and dexamethasone (or BD), followed by autologous stem cell transplantation, and a prolonged course of treatment with bortezomib and dexamethasone after transplantation. This type of treatment has been very effective in multiple myeloma. However, there is little experience with this treatment in patients who have Monoclonal Immunoglobulin Deposition Disease (MIDD) or amyloidosis. The investigators and others have treated patients who have MIDD and amyloidosis with bortezomib and autologous stem cell transplantation and have had success with this treatment. But the combination of autologous transplant with BD given before and after the transplant is a new way of treating these diseases, which the investigators believe will be very effective.
This was an open-label, single-arm, pilot study of the recombinant MAGE-A3 protein plus the immunological adjuvant AS15 (recMAGE-A3 + AS15) in subjects with symptomatic multiple myeloma who had completed induction therapy with at least a Very Good Partial Response (VGPR) by the International Myeloma Working Group (IMWG) criteria and who were eligible for high-dose chemotherapy with autologous stem cell transplant (auto-SCT). The primary objective was to determine the safety and tolerability of immunizations when administered prior to stem cell mobilization and multiple times after stem cell reinfusion. Secondary objectives were to assess the humoral and cellular immunogenicity and clinical outcomes of immunization.
This is a research study to evaluate two different Lenalidomide doses (15 mg vs. 25 mg) in combination with low dose dexamethasone in patients with relapsed multiple myeloma. The investigators propose to use the need for dose reduction as a criterion to judge tolerability from various causes. In the veteran population which predominantly is in the older age category with number of co-morbidities, a lower dose regimen may be safer and advantageous. This study expects to enroll approximately 80 subjects from participating VA sites across the nation. The investigators will evaluate the safety of the two dose regimens by comparing frequency of dose reductions. The investigators will also measure how long the responses last with each dose. Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental. At the time of enrollment, one-half of the subjects will be chosen at random to receive the 15 mg Lenalidomide dose and the other half will take the 25 mg dose regimen of Lenalidomide. Depending on lenalidomide treatment assignment, subjects will receive either 15 mg p.o. q.d. or 25 mg p.o. q.d. for days 1-21 of a 28 day cycle. In addition, dexamethasone (40 mg) will be added once a week (Days 1, 8, 15 and 22) to the Lenalidomide regimen, with a dose reduction on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. ASA (81 or 325mg) will be given daily for anticoagulation prophylaxis. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to 2.5.