View clinical trials related to Neoplasms, Plasma Cell.
Filter by:This study will evaluate GMI-1271, a specific E-selectin antagonist, in multiple myeloma as adjunct to standard of care chemotherapy used to treat this disease.
This is an open-label, multicenter study to confirm the safety and efficacy of durvalumab + daratumumab (D2) in subjects with relapsed and refractory multiple myeloma. This study will also explore the safety and efficacy of the addition of pomalidomide + dexamethasone to durvalumab + daratumumab (PD3). On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US) Food and Drug Administration (FDA). The decision by the FDA was based on data related to risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into this study has been discontinued. Subjects who are receiving clinical benefit, based on the discretion of the investigator, may remain on study treatment after being reconsented.
The purpose of this study for Phase l is to determine the maximum tolerated dose of panobinostat given in combination with carfilzomib, lenalidomide, and dexamethasone in 28-day cycles as induction (initial) therapy to participants with newly diagnosed multiple myeloma. In Phase ll, investigators will evaluate the safety (side effects) and efficacy (effectiveness) of panobinostat in combination with carfilzomib, lenalidomide, and dexamethasone.
The Primary objective of this study is to compare serum levels of Macrophage-Colony Stimulating Factor (M-CSF) in a population of patients with multiple myeloma (MM), in a population of patients with Monoclonal Gammopathy of Undetermined Significance (MGUS) and in a control population.
This observational, non-interventional, retrospective, multicenter, national study focuses on collecting information about the effectiveness and safety of bortezomib re-use at first relapse in MM patients already treated in their first line with a bortezomib-based regimen, re-challenged with the same drug according to current clinical practice and/or Italian SIE/SIES/GITMO, IMWG and/or NCCN Guidelines/Treatment Recommendations. Data will be collected retrospectively from approximately 25 haematologic/oncologic sites in Italy. Approximately, data of up to 100 patients will be collected.
This will be a single-arm, open-label study. Patients will be enrolled during induction therapy for multiple myeloma, prior to standard-of-care consolidation with autologous stem cell transplantation (ASCT). T cells will be harvested for T cell manufacturing prior to ASCT, and CART-19 will be infused at day ~60 post-ASCT, 3 days after lymphodepleting chemotherapy. The primary endpoint is progression-free survival (PFS) after ASCT. As detailed below, the study is powered to detect an increase in two-year PFS to ~75% from a baseline expectation of 55% based on historical data. Secondary endpoints will evaluate CART-19 persistence and function, minimal residual disease, immune correlative endpoints, and associations of progression-free survival (PFS) with CART-19 persistence and clinical and biologic characteristics of multiple myeloma.
The purpose of this study is to determine whether the efficacy of gemcitabine is comparable with the efficacy of the standard chemotherapy with vinorelbine for mobilization of autologous stem cells in myeloma patients
The purpose of this pilot study is to gain initial insights into the biologic and clinical effects of Atezolizumab in patients with Asymptomatic Multiple Myeloma (AMM). The data may provide novel insights into anti-PDL-1-induced immunologic changes, which could potentially be relevant to its future development in Multiple Myeloma (MM) and other indications.
Phase I: The primary purpose of this study phase is to determine the best dose also referred to as the maximum tolerated dose (MTD) of Selinexor when used in combination with high-dose melphalan as a conditioning regimen for hematopoietic cell transplant. Phase II: The primary purpose of this study phase is to assess the complete response (CR) conversion rate.
This clinical trial is a multicenter, cohort, with one arm to study the SLP to 18 months of Velcadito scheme (velcade 1.0 mg / m2 administered over two days with melphalan and prednisone) in patients with MM diagnosis again higher 75. After completion of the protocol patients were still approximately every two months, in clinical practice, to observe the survival and answers to other treatments. All the scans are part of the normal routine. The realization of diagnostic tests and drug treatment will be performed regardless of the patient's participation in the study as part of routine clinical practice All patients who meet criteria. The incidence of MM age-adjusted to cover the participating hospitals is estimated in 44 patients. Patients will receive a course of 4 weeks duration of Melphalan / Prednisone / Velcade consist in Melphalan, 9 mg / m2 orally daily 1-4 and Prednisone 60 mg / m2 orally on days 1 to 4, in combination Velcade with a dose of 1.3 mg / m2 sc twice weekly (days 1, 4, 8, 11), followed by 2 weeks of rest (cycle duration of 4 weeks) and seven four-week cycles duration of melphalan / prednisone / Velcade consist in Melphalan, 9 mg / m2 orally on days 1 to 4 and prednisone, 60 mg / m2 orally on days 1 to 4, in combination with Velcade, at doses of 1, 0 mg / m2 sc (days 1, 4). Melphalan and Prednisone will be dispensed for oral administration. The Melphalan should be administered in a single two hours separately taking any food and prednisone be taken in the morning with or immediately after a meal. The amount in mg will be calculated based on the body surface, to be calculated on day 1 of each cycle. Velcade for administration, calculated on day 1 of the cycle will be the same dose throughout the entire cycle. If a patient experiences a gain or loss of remarkable weight within the cycle, the dose to be administered will be recalculated based on the new body surface. The appropriate amount of Velcadeserá dispensed in a sc injection. Velcade dose between two leave at least 72 hours