Allo HSCT Using RIC for Hematological Diseases
Acute Myelogenous LeukemiaAcute Lymphocytic Leukemia16 moreThis is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related or unrelated donor stem cell infusion. The primary objective is to evaluate rates of acute graft-versus-host disease (GVHD) grades II-IV and chronic GVHD with an updated GVHD prophylaxis of tacrolimus and mycophenolate mofetil (MMF) with a non-myeloablative preparative regimen in persons with hematologic malignancies.
MMRF Molecular Profiling Protocol
Multiple MyelomaPlasma MalignancyThis protocol is now being used as screening for the MyDRUG study
Superiority of VCD Versus CTD in Patients With Newly Diagnose Multiple Myeloma Eligible for Transplantation...
Multiple MyelomaEffects of ChemotherapyThis study compared two main different induction protocols used to treat myeloma eligible patients in Brazil. VCD against CTD.
Sequential High-dose Dexamethasone and Response Adopted PAD or VAD Induction Chemotherapy Followed...
Multiple MyelomaComplete Response (CR) plus near CR rate of VAD (Vincristine, Adriamycin, Dexamethasone) induction chemotherapy followed by ASCT in patients with newly diagnosed MM was about 50% and CR plus near CR rate of PAD (Bortezomib, Adriamycin, Dexamethasone) induction chemotherapy followed by ASCT in patients with newly diagnosed MM was about 60%. If the CR with near CR rate of sequential high-dose dexamethasone and response adopted PAD or VAD induction chemotherapy followed by ASCT is more than 60%, this combination will be accepted as active regimen that may be worth for investigating in phase III trial. But, if the CR with near CR rate of this regimen is lower than 50%, this has not a merit than VAD induction chemotherapy. Based upon the above assumption, this trial was designed by using Simon's optimal two-stage testing procedure. Assuming a target level of interest, p1=0.6, and a lower activity level, p0=0.5. Initially 61 patients will be accrued. If 33 or more CR + near CR rate were observed, the trial will be continued. Accrual will be planned to a total of 190 patients. If total 106 or more patients were assessed as CR with near CR, sequential high-dose dexamethasone and response adopted PAD or VAD induction chemotherapy regimen will be accepted as active regimen. This design provides probability 0.05 of accepting drugs worse than p0 and probability 0.20 of rejecting drugs better than p1. If we assume that drop-out rate is 10%, total accrual patient will be 210. Patient characteristics and toxicity will be evaluated by descriptive methods. Progression free survival and overall survival (median value, 95% confidence interval) will be calculated by Kaplan-Meier method.
Unrelated Donor Stem Cell Transplantation
Severe Aplastic AnemiaParoxysmal Nocturnal Hemoglobinuria11 moreThe purpose of this study is to provide an opportunity for patients with malignancies or bone marrow failure states who lack a suitable sibling donor to undergo allogeneic hematopoietic progenitor cell transplantation using cells from unrelated individuals or cord blood registries.
Trial of an Augmented Mobilization Strategy With Plerixafor (Mozobil®) in a Population at Risk for...
Multiple MyelomaLymphomaPoor mobilization of hematopoietic progenitors needed to support autologous transplantation is a serious clinical problem. We are investigating the role of plerixafor administered in an at risk population to augment successful stem cell collection. OBJECTIVES To determine if plerixafor when administered on the day prior to planned autologous collection on first mobilization attempt in those with a peripheral blood CD34 ≤ 10X106/L will: increase the number of patients successfully collected in one day increase the number of patients successfully mobilized on first collection attempt is cost neutral within a Canadian setting
Combined Bone Marrow Transplantation (BMT) and Renal Transplant for Multiple Myeloma (MM) With End...
Multiple MyelomaEnd Stage Renal DiseaseThe primary objective is to cure multiple myeloma with less toxic allogeneic bone marrow transplantation while inducing renal allograft tolerance through mixed chimerism in patients with end stage renal failure and multiple myeloma
PK Study of Melphalan HCL & Alkeran for Injection of MA Conditioning in MM Patients of Autologous...
Multiple MyelomaTo assess and compare the pharmacokinetics of Melphalan HCL for Injection (Propylene Glycol-Free) versus Alkeran for Injection in multiple myeloma (MM) patients undergoing autologous stem cell transplant (ASCT).
Safety Study of a Chemokine Receptor (CXCR4) Antagonist in Multiple Myeloma Patients
Multiple MyelomaBKT-140 drug substance is a highly selective chemokine receptor (CXCR4) antagonist, which is developed by Biokine as a novel therapy for Multiple Myeloma (MM, a type of blood cancer). The unique combination of activities of BKT140, i.e., the induction of the exit of blood cells such as stem cells and mature cells from the bone marrow to the peripheral blood, coupled with specific induction of MM cell death by BKT-140, represents a novel therapeutic strategy against MM.
Assessment of Molecular Remission by ASO-qPCR After Bortezomib-dexamethasone (Vel/Dex) Followed...
Multiple MyelomaThe primary objective of this study is to determine the rate of molecular remissions (MolR) assessed by ASO-RQ-PCR technique after induction treatment with bortezomib and dexamethasone (Vel/Dex) prior to high-dose therapy with melphalan and autologous stem cell transplantation (HDT-ASCT), and after HDT-ASCT in patients with multiple myeloma.