Study of the Glutaminase Inhibitor CB-839 in Hematological Tumors
Non-Hodgkin's Lymphoma (NHL)Multiple Myeloma4 moreMany tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival. To exploit the dependence of tumors on glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine utilization, glutaminase, will be tested in this Phase 1 study in patients with advanced hematologic malignancies. This study is an open-label Phase 1 evaluation of CB-839 in subjects with hematological tumors. Patients will receive CB-839 capsules orally two or three times daily. The study will be conducted in 2 parts. Part 1 is a dose escalation study to identify the recommended Phase 2 dose and will enroll patients with advanced and/or treatment-refractory Non-Hodgkin's Lymphoma (NHL), Multiple Myeloma (MM), or Waldenström's macroglobulinemia (WM) In Part 2, all patients will receive the recommended Phase 2 dose. This part will enroll patients with advanced and/or treatment-refractory Non-Hodgkin's Lymphoma (NHL), Multiple Myeloma (MM), or Waldenström's macroglobulinemia (WM). All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug), pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may predict responsiveness in later studies), and tumor response. As an extension of Part 2, a cohort of patients with relapsed and refractory MM will be enrolled to receive low dose dexamethasone and CB-839. A second cohort of patients with relapsed or refractory disease following at least 2 prior treatment regimens will be enrolled to receive CB-839 in combination with standard-dose pomalidomide and low-dose dexamethasone to further evaluate this triple combination.
MLN9708 (Ixazomib) in Combination With Panobinostat and Dexamethasone in Multiple Myeloma
Multiple MyelomaKahler Disease2 moreThis study will look at the safety and tolerability of the new drug MLN9708 in combination with the existing drugs panobinostat and dexamethasone among patients with relapsed or refractory multiple myeloma. This study will also look at the response and clinical benefit of the treatment and the progression-free survival and overall survival of study participants.
Safety and Efficacy of POL6326 for Mobilization/Transplant of Sibling Donor in Patients With Hematologic...
Acute Myeloid Leukemia in RemissionAdult Acute Lymphoblastic Leukemia in Remission7 moreDetermine the safety and tolerability of POL6326 when used as a single mobilization agent.
Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple...
Multiple MyelomaThe purpose of the study is to assess the concentration of Elotuzumab in Myeloma patients with very low kidney function including patients on dialysis.
Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide
MyelomaThe main purpose of this study is to see whether pomalidomide can help people with myeloma. Researchers also want to find out if pomalidomide is safe and tolerable.
A Dose Escalation Study of the Histone Deacetylase Inhibitor (HDACi) JNJ 26481585 in Combination...
Multiple MyelomaThe purpose of this study is to evaluate the safety and tolerability and to establish the maximum tolerated dose of JNJ-26481585 combined with VELCADE and dexamethasone.
An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without...
Multiple MyelomaThe purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.
Adoptive Immunotherapy in Relapsed Hematological Malignancy: Early GVHD Prophylaxis
Hodgkin's LymphomaLymphoid Leukemia17 moreDetermine the relapse-free, donor lymphocyte infusion (DLI)-free survival in patients receiving the investigational regimen.This is a randomized phase II clinical trial, comparing two different dosing schedules of mycophenolate mofetil for graft versus host disease (GVHD) prevention following allogeneic stem cell transplantation. Risk for relapse, GVHD and non-relapse mortality will be assessed. Adaptive randomization between two study arms will be performed based on T cell counts at day 60.
Pembrolizumab (MK-3475) in MM Patients With Residual Disease
Multiple MyelomaThis is a national, multicenter, open label single-arm, non-comparative study that will determine the efficacy, safety and the changes in selected pharmacodynamics markers of MK-3475 monotherapy administered as consolidation therapy in MM patients who have achieved a response with a previous treatment but who still display some residual disease. For this purpose, 20 MM patients, who have received any treatment of limited duration either at diagnosis or at first relapse, and that have achieved a good response (≥VGPR) but with persistent residual disease (that is patients in VGPR, non-stringent CR, or MRD+ sCR), will be treated with MK-3475 monotherapy administered iv at a dose of 200 mg every three weeks for 1 year, with a potential expansion of 1 additional year of treatment in case of clinical benefit and patient agreement. Efficacy, safety and pharmacodynamic parameters will be evaluated to understand the role of this monoclonal antibody in this setting.
CART-BCMA Cells for Multiple Myeloma
Multiple MyelomaOpen-label, single-center, pilot study to assess the safety and feasibility of infusion of autologous T cells expressing BCMA (B-cell maturation antigen)-specific chimeric antigen receptors with tandem TCR and 4-1BB costimulatory domains (referred to as CART-BCMA ) in adult patients with multiple myeloma (MM). CART-BCMA cells will be given as a split dose intravenous infusion over 3 days. The duration of active intervention and monitoring is approximately 2 years.