Microdose Study of Melphalan, Bortezomib and Dexamethasone
Multiple MyelomaThe purpose of the study is to identify specific genes that are up- or downregulated in multiple myeloma patients who receive a microdose of either Melphalan (Alkeran®), Bortezomib (Velcade®) or Dexamethasone (Dexaven®). The study treatment constitutes 1% of the planned standard myeloma treatment and will be given two hours prior to standard treatment. Blood samples are taken at baseline, 15, 30, 60 and 120 minutes for microarray analysis.
Study of Risk Factors and Genetic Association With Bortezomib-induced Peripheral Neuropathy in Multiple...
Multiple MyelomaBackground and objective The introduction of a proteasome inhibitor bortezomib has significantly improved response rates and overall survival in patients with multiple myeloma (MM), and it has soon become the cornerstone of treatment in both newly diagnosed and relapsed/refractory settings. However, the incidence of peripheral neuropathy related to bortezomib (BiPN) is unignorable and which becomes an obstacle during treatment with bortezomib, either alone or in combination. Until now, there are no consistent findings regarding the risk factors that may cause BiPN. There is either lack of large scale study of BiPN in Taiwan. This study aims to clarify risk factors of BiPN using retrospective analysis in a large cohort with longer observation period as well as the relations between BiPN and gene polymorphisms, and to compare different routes in the incidence of BiPN. Methods This is a retrospective cohort study with a sample size of about 400 MM patients treated ever with at least one full cycle of bortezomib in the institution. All the patients enrolled need to be adults (≧20 years ) with measurable M-component in either blood or urine. The investigators will perform a retrospective chart review to collect clinical data, including anti-MM and concomitant medications, to evaluate the incidence and severity of BiPN in this cohort, as well as any meaningful risk factors contributed to BiPN. The investigators also plan to perform genotyping for the possible genetic factors associated with development of BiPN. Expected contributions The successful collaboration between clinical hematologist-oncologist and biopharmaceutical researcher would result in the concrete evidence of efficacy and safety of bortezomib in Taiwanese patients with MM. The findings in this large cohort study will unveil the risk factors of BiPN, including the administration routes and ethnicity. As results, the investigators would be able to provide the precision medicine-based bortezomib treatment strategy to MM patients in Taiwan.
Level of Physical Activity and Its Associations With Fatigue and Quality of Life in Multiple Myeloma...
Multiple MyelomaThe purpose of this study is to gives understanding to level of physical activity, occurrence of fatigue and quality of life amongst multiple myeloma survivors in the local setting. As multiple myeloma survival improves, it is vital to focus on interventions that will help to maximize QOL. A positive correlation may suggest that exercise is such an intervention. The hypothesis are multiple myeloma survivors are performing low levels of physical activity. Higher levels of physical activity will be associated with higher levels of QOL and lower fatigue levels.
Genomic-Based Diagnosis, Classification and Targeted Treatment of Multiple Myeloma
Multiple MyelomaMultiple myeloma is an incurable bone marrow cancer characterized by an abnormal expansion of plasma cells that secretes monoclonal immunoglobulin. Over the years, the molecular and genetic heterogeneity of the disease have been dissected. With the maturation of technologies, the time is ripe now to apply genomics to diagnose, classify, risk-stratify and prognosticate myeloma in the clinical setting and use this information to guide current treatment. The investigators hypothesize that the use of gene expression profiling as a single test will be more economical, efficient and accurate compared to the current standard panel of tests done at diagnosis. The investigators also hypothesize that the investigator can use predictive markers to identify prospectively patients who will respond to Velcade and that with more effective trebasedonatment, ability to measure depth of response beyond conventional complete response become important since more patients are achieving conventionally determined complete response. Using a cohort of patients treated on a standard treatment protocol based on Velcade-based induction treatment followed by consolidation and maintenance treatment, the investigators will study specifically the feasibility and accuracy of gene expression diagnostics, the predictive power of the investigators predefined predictive markers and the clinical utility of minimal residual disease measurement in myeloma. The results of the investigators study will allow us to improve the diagnosis, and prognostication of MM patients The investigators hypothesized that this will speed up diagnosis, provide comprehensive information for the classification and risk stratification of MM patients and can completely replace the current FISH assay and may be cheaper. The investigators hypothesized that TRAF3 deletion or mutation and MYC activation will identify patients that will have a significantly better response to Velcade. Modern treatment induced deeper response. More sensitive method of disease detection will allow us to know the fully extent of response to these treatment
Rationale for Cytogenetic Risk Stratification by Imaging Flow Cytometry in Multiple Myeloma
Multiple MyelomaA pioneer study demonstrated a proof of concept for IS-FISH with the new ISX technology. This state of the art technology has been recently acquired by the CHU of Amiens. In the present study the investigators want to establish a workflow for simultaneous immunostaining and characterization of FISH cytogenetic pathological signals with the imaging flow cytometer ISX, such as chromosomic gains, losses and translocations in multiple myeloma (MM). The gold standard technology for the detection of prognostic cytogenetic aberrations in MM is a FISH analysis after bone marrow (BM) plasma cells sorting (PCS).2,3 In MM, plasma cells isolation is usually based on CD38 and/or CD138 expression. Cytogenetic risk stratification is guided by the detection of 4 chromosomal aberrations: TP53 and CDKN2C deletions, CKS1B gains and t(4;14) translocation. Thanks to ISX technology the investigators may avoid cumbersome task of cell sorting (outsourced service for our hospital) meanwhile measuring precisely and qualitatively aberrant FISH signals on a large amount of cells.
Postmarketing Study of Empliciti in Korean Patients With Multiple Myeloma
Multiple MyelomaThis study is a regulatory postmarketing surveillance study for Empliciti with a representative sample of the overall Korean multiple myeloma (MM) population.
Expanded Access Single Named Patient Program With Elotuzumab (BMS-901608) for the Treatment of Patient...
Multiple MyelomaTo provide elotuzumab treatment for single-patient use.
Early Patient Access Treatment Use Protocol CA204-220
Multiple MyelomaThe objective of this expanded access program is to provide treatment with elotuzumab in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma at Japanese sites where licensed physicians determine clinical need.
Expanded Access Request Program for Belantamab Mafodotin (GSK2857916) in Multiple Myeloma
Multiple MyelomaCompassionate use access to belantamab mafodotin (GSK2857916) for eligible participants with refractory/relapsing multiple myeloma
Expanded Access to Elotuzumab (Empliciti) for Multiple Myeloma
Multiple MyelomaAt BMS, we work with physicians/investigators to make investigational products available to patients with life-threatening diseases that have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. When contacted by a treating physician, BMS will consider requests for providing early patient access to Elotuzumab in patients with multiple myeloma who are residents of Belgium, Thailand, Turkey, Argentina, and Colombia.