Active clinical trials for "Neoplasms, Plasma Cell"

This study will collect blood samples from healthy volunteers and volunteers with multiple myeloma who are going to get the seasonal flu, pneumonia, haemophilus influenzae B (HIB), and/or meningococcus vaccines. The main goal of the study is to start to identify differences in the immune response between multiple myeloma patients and people who don't have multiple myeloma. We hope this will provide important information about the best way and time to vaccinate multiple myeloma patients to flu, pneumonia, haemophilus influenzae B (HIB), and/or meningococcus .

Multiple myeloma (MM) is an incurable disease that is characterized by the accumulation of clonal plasma cells in the bone marrow. While MM patients with relapsed disease may achieve responses to subsequent antimyeloma therapies, the duration of response decreases with successive relapses until resistant disease develops. Until recently, the median survival following relapse after induction therapy was approximately one year. The relatively recent US Food and Drug Administration (FDA) approvals of bortezomib (2003) and combination lenalidomide plus dexamethasone (2006) therapies for the treatment of previously treated MM has provided effective therapeutic options that give patients with relapsed or refractory MM the prospect for a prolongation of overall and progression-free survival times. However, MM remains an incurable disease. A clear unmet medical need still exists for additional novel therapeutic options for the treatment of previously treated MM. Plerixafor reversibly inhibits CXCR4 binding to stromal cell derived factor (SDF)-1alpha and was recently discovered to be an effective agent to mobilize CD34+ cells into the peripheral blood. In normal volunteers, administering Plerixafor after 4-5 days of G-CSF resulted in a 3-3.5 fold increase in circulating CD34+ cells. Two phases 3 studies demonstrated that the combination of G-CSF and Plerixafor is superior to G-CSF alone for mobilizing hematopoietic progenitor cells in front-line or as salvage therapy in patients with multiple myeloma. Nevertheless, almost all patients ultimately relapse, and no plateau is observed in the survival curves. At the time of disease recurrence, there is not one standard salvage approach, but instead, various therapeutic options are available, including novel agents-based therapy, administered for a fixed duration of time or until progression. In the pivotal trial for the approval of bortezomib as monotherapy in relapsed and refractory MM, the median PFS was 7 months, whereas in the pivotal trials for the approval of lenalidomide in combination with dexamethasone in the same group of patients, the median time to progression was approximately 11 months. A more recent prospective, randomized, phase 3 study has shown that a triplet combination of bortezomib, thalidomide and dexamethasone (VTD) achieved superior results compared to thalidomide dexamethasone (TD) alone in patients relapsing following ASCT, with a median time to progression of 19.5 versus 13.8 months, respectively. This study suggests that combinations consisting of both an IMiD and a proteasome inhibitor are a valuable option at the time of relapse. However, when a frozen graft is available, it is also possible to repeat high-dose therapy in patients who previously responded to the frontline application of high-dose melphalan and ASCT. Over time, several reports have demonstrated the feasibility of this salvage strategy. The majority of data are available from retrospective studies and are based on single-centre experiences with small numbers of selected patients. In this setting, PFS has been shown to range from 7 to 22 months, and the treatment-related mortality (TRM) was acceptable, ranging from 0 to 8%. Various prognostic factors for prolonged PFS have been described, such as the duration of response to the first high-dose therapy, or the number of lines of therapy prior to salvage ASCT. With this background, this prospective non-interventional multicentre study will aim to collect data on the feasibility of salvage ASCT using a Plerixafor-based stem cell mobilization in relapsed MM, according to Plerixafor label in France. This is a non-interventional study; visit will be performed as usual, according to each center practices. No additional visits will be requested for the study purpose. The date for each visit and any data generated must be recorded on the appropriate eCRF. The study will consist of 3 periods: An early screening period Autologous stem cell mobilization period High dose melphalan therapy and autologous graft infusion and follow-up for12 months after salvage ASCT Inclusion visit This visit may occur up to 28 days before Mozobil® administration. This visit will be performed during the visit of pre-transplant assessment. For the pre-transplant assessment, the procedures are performed routinely before ASCT even if the patient is not included in the study: Stem cell mobilization phase The stem cell mobilization phase is performed according to standard practice of each participating centre. Follow-up visits High dose melphalan administration and autologous graft infusion will be performed according to each centre standard practice. Patients will be followed according to each center practices. The follow-up of this non-interventional study will end 12 months after ASCT. Subjects will be enrolled over a 2 years period. The total duration of the study will be 36 months

The purpose of this study is to assess the 2-year progression-free survival rate.

To understand the safety and efficacy of Revlimid® 2.5mg and 5 mg Capsules (hereinafter referred to as Revlimid) in all patients who are treated with it under the actual condition of use pursuant to the conditions of approval. Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled is reached. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end on the day when the approval condition related to all-case surveillance is terminated.

This protocol seeks to enroll smoldering multiple myeloma (SMM) and monoclonal gammopathy of undetermined significant (MGUS) patients with λ light chain (LC) involvement, a group of patients for whom standard of care is observation not treatment. Patients with SMM and MGUS have a precursor plasma cell disorder from which light chain amyloidosis (AL) can evolve. In this trial, enrolled subjects will have blood and if available bone marrow cells evaluated by molecular testing to determine their clonal λ LC variable region (VL) germline gene. Seventy percent of AL cases involve just 7 germline donors, 5 of which are λ germline donors. The hypothesis that will be tested with this protocol is that the presence of AL germline genes associated with AL in patients with a pre-existing diagnosis of λ SMM or λ MGUS indicates the presence of AL or risk of progression to AL.

Autologous hematopoietic cell transplantation is currently considered the standard therapy of multiple myeloma (MM) for elegible patients. On the contrary, despite new developments in transplant procedures and supportive care, allogeneic bone marrow transplantation is less commonly used due to high transplant related mortality (TRM). No consensus statement about allografting in MM has so far been reached and only a minority of patients undergoing allografting are enrolled in prospective clinical trials. Moreover, use of unrelated donors is considerably increased over the time and the recent activity survey of European Group for Blood and Marrow Transplantation (EBMT) showed that the number of allografts from unrelated donor is higher than that one from HLA-identical siblings in Europe. In order to evaluate trends in allograft from unrelated donors in multiple myeloma patients, the investigators plan to conduct a restrospective study through the Italian Bone Marrow Transplantation Registry (IBMDR) over a period ranging since 2000 to 2009. Data will be collected from the central data management system Promise (Project Manager Internet Server) used by EBMT and from IBMDR. The aim of the study is to evaluate the role of unrelated donor allograft in multiple myeloma over the last decade and hopefully offer recommendations on patient selection. Primary endpoints of the study are: a) Overall Survival (OS) from diagnosis and from the allograft b) Event-Free-Survival (EFS) from the allograft. Disease response criteria will be defined according to the International Uniform Response Criteria for multiple myeloma. Transplant related mortality, Graft-Versus-Host-Disease (GVHD), either acute or chronic (limited/extensive) will be evaluated as cumulative incidences. Univariate and multivariate analysis will be calculated for the transplant-related and patient-related characteristics.

The purpose of this study is to understand if small proteins found on the surface of myeloma cells (called CXCR4 and CD47) or inside the myeloma cells (Pim kinases, sphingolipids, and pS6) can predict how patients will respond to chemotherapy-treatment and if a small molecule inside the myeloma cells (called Pim kinase) can be used as a treatment target for myeloma. A sample from the bone marrow biopsy (a small amount of tissue removed from the body for laboratory testing) and aspirate (a small amount of fluid is removed from the body for laboratory testing) that had been done before the subject entered this study will be provided for research purposes. Based on preliminary data, it is hypothesized that CXCR4, CD47, sphingolipids, and Pim kinases could be used as prognostic/predictive markers and that Pim kinase inhibitors provide a new agent for the treatment of multiple myeloma.

In the present study we are planning to study electrophysiological changes related to the dose and time of bortezomib administration in newly diagnosed patients with MM, during the first months of treatment and 6 months after ending. In addition a possible correlation between the incidence of BIPN and the subtype of myeloma and other risk factors will be investigated.

The purpose of this registry is to record information on therapy reality of malignant lymphatic systemic diseases by office-based haematologists in Germany.

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at DNA samples from patients with multiple myeloma.