A Study of GSK2110183 in Subjects With Proteasome Inhibitor Refractory Multiple Myeloma
CancerThis is a single arm, open-label, Phase Ib/II study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of the oral AKT inhibitor, GSK2110183, when administered to subjects with proteasome inhibitor refractory multiple myeloma (MM). During Part 1 of the study, GSK2110183 will be administered to subjects in sequential Pharmacokinetic (PK) Cohorts on a continuous daily dosing schedule in 21-day cycles until one of the Treatment Discontinuation Criteria is met. The PK Cohorts will characterize the PK of GSK2110183 in plasma and urine as well as determine the Recommended Phase 2 Dose (RP2D) of GSK2110183. The RP2D will be that dose that provides adequate PK exposure and biologic activity without exceeding the maximum tolerated dose (MTD) in MM subjects as defined in the current study. In Part 2 of the study, the RP2D will be further evaluated using a flexible 2-stage design with a stopping rule to allow for early termination based on lack of efficacy at the end of Stage 1. The first stage will accrue 20 subjects who will receive GSK2110183 at the RP2D. If a clinical response is observed in at least 1 subject in Stage 1, the study will proceed to Stage 2 and 20 additional subjects will be enrolled. GSK2110183 will be administered in Part 2 (Stage 1 and Stage 2) on a continuous daily dosing schedule in 21 day cycles until International Myeloma Working Group criteria for progression are met, at which point the subject will proceed to GSK 2110183 + bortezomib salvage therapy provided they meet the additional eligibility criteria for this phase of the study. GSK2110183 and bortezomib will be continued until one of the Treatment Discontinuation Criteria is met. Exploratory PK/PD analyses may be performed to examine the potential relationships between GSK2110183 pharmacokinetics and pharmacodynamic biomarkers.
UARK 2010-35, A Study of Expanded Natural Killer Cell Therapy for Multiple Myeloma
Multiple MyelomaThe purpose of this study is to determine the therapeutic efficacy of the exp-NK cell therapy in research participants with relapsed high risk MM [defined as gene expression profile (GEP) 70 gene score ≥0.66 and/or metaphase chromosomal abnormalities and/or high LDH ≥ 360U/L] by establishing the (near) complete response rate. Response rate will be compared to case matched historical controls (patients who relapsed on Total Therapy 2 or 3 with high-risk MM defined as above). Disease-free survival and overall survival will be captured but are not primary or secondary endpoints.
Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma
Smoldering Multiple MyelomaThe aim of the study is to evaluate the effect of statin administration on the course of progressive Smoldering Multiple Myeloma.
PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation
Non-Hodgkin's LymphomaMultiple MyelomaThis is an open-label, single-arm, multicentre study conducted in Spain to estimate the effectiveness of palifermin administered at a dose of 60 mg/kg/day IV for 3 consecutive days before the start of the conditioning regimen and for 3 consecutive days after autologous PBSCT for treating oral mucositis in patients with NHL and MM who have received high-dose conditioning chemotherapy.
Chemoprevention Therapy in Treating Patients at High Risk of Developing Multiple Myeloma
Multiple Myeloma and Plasma Cell NeoplasmRATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Dehydroepiandrosterone and clarithromycin may be effective in preventing multiple myeloma. PURPOSE: Randomized phase II trial to compare the effectiveness of dehydroepiandrosterone with that of clarithromycin in treating patients who may be at a high risk of developing multiple myeloma.
Alemtuzumab Plus Fludarabine and Melphalan With or Without Cyclosporine, Mycophenolate Mofetil,...
LeukemiaLymphoma3 moreRATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects of alemtuzumab, fludarabine, and melphalan with or without cyclosporine, mycophenolate mofetil, and total-body irradiation before donor peripheral blood stem cell transplant and to see how well they work in treating patients with relapsed or refractory hematologic cancer.
The Aim is to Identify Recurrent Genomic Mutations and/or Predisposing Polymorphisms in Patients...
Multiple MyelomaThere is a growing body of data suggesting that the the risk of developing multiple myeloma, or myelomagenesis, is associated with genetic alterations occurring in the tumor cells. A limited number of candidate genes and polymorphisms have been reported in patients with this disease. In this study the investigators will compare the genetic information obtained on purified abnormal plasmocytes obtained from patients with multiple myeloma with available public databases in an effort to identify and if possible validate the role of certain mutations and/or polymorphisms in myelomagenesis. Plasmocytes will be obtained by immunomagnetic enrichment using CD138+ beads.
Comparison Between FDG-PET and MRI for the Assessment of Response to Intensive Chemotherapy in Multiple...
Multiple MyelomaComparison between FDG-PET and MRI for the assessment of response to intensive chemotherapy in multiple myeloma patients.
Examination of Trends in Multiple Myeloma Trial Patient Experiences
Multiple MyelomaHistorically, participation in clinical trials has been highly skewed towards specific demographic groups. However, research identifying which trial attributes impact participation, in either positive or negative ways, is limited. This study invites participants to record a wide range of data on their clinical trial experience, with the goal being to identify factors which persistently limit patients' ability to participate in, or complete, a trial in which they were initially interested. Data will be analyzed through a range of demographic lenses, in hopes of discovering patterns which might improve the experience of future multiple myeloma patients.
Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures...
Multiple MyelomaThe purpose of this study is to find out how balloon kyphoplasty (surgical repair of the patient's fracture using balloons and bone cement) compares to non-surgical treatment in reducing vertebral compression fractures while providing pain relief and improved function and quality of life.