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Multiple Myeloma (MM) is a molecularly heterogeneous disease with a high degree of genomic instability. Despite improvements in event-free survival and overall survival with the use of autologous stem cell transplantation and novel agents, MM remains an incurable disease (1,2). The best induction
Working hypothesis
- 1. Patients who receive a Hematopoietic Stem Cell Transplantation (HSCT) who follow a comprehensive rehabilitation program, have fewer post-transplant complications, reduce the number of hospital stay days, and return to their daily lives more quickly.
- 2. The economic costs
Indication:
This study will include subjects that have relapsed and refractory multiple myeloma (RRMM) after treatment with at least 3 prior antimyeloma therapies, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD®) or after development of double-refractoriness to a both a PI
Background
Chronic cold agglutinin disease (CAD) is mediated by monoclonal cold-reactive autoantibodies that bind to erythrocyte surface antigens, causing hemagglutination and complement-mediated hemolysis. Anemia is severe in one-third of patients (hemoglobin level 8.0 g/dL or lower). Cold-induced
Multifocal motor neuropathy (MMN) is a chronic immune mediated neuropathy, which affects patients at a relatively young age and necessitates treatment with immunoglobulins (Ig) to improve and maintain muscle strength. Subcutaneous immunoglobulin (SCIG) therapy for MMN is equally efficacious to
This was a randomized, double-blind, placebo-controlled pilot study of SBI, colesevelam, and placebo in patients undergoing autologous HSCT for the clinical care of multiple myeloma.
The number of adults undergoing hematopoietic stem cell transplant (HSCT) has grown significantly over the past two
Overall design. This study is a Multicenter, Open-label, Phase 2 study of Carfilzomib Weekly +MP in Untreated Elderly MM. Eligible patients must have a symptomatic, untreated MM with a measurable disease. There is a dose escalation part in the study as the MTD remained to be determined for
The role of the proteasome in carcinogenesis and cell survival has been well established, and its inhibition associated with an accumulation of pro-apoptotic proteins and cell death. Proteasome inhibitors, such has bortezomib, have been extensively studied and are widely used as effective therapy in
Multiple myeloma (MM) is one of the most common hematological diseases and besides the option of an allogeneic stem cell transplantation remains incurable.
Although autologous stem cell transplantation and new compounds such as bortezomib, thalidomide and lenalidomide have been implemented,
Scientific background. Diabetes mellitus is associated with an increased prevalence and incidence of cardiovascular diseases. It is believed that the high cardiovascular risk in diabetes is attributable to the adverse effects of glucotoxicity and lipotoxicity on endothelial cells. Recent data
PRIMARY ENDPOINTS:
Phase I • Determination of the MTD of the combination therapy
Phase II:
• Response rate (CR+PR)
SECONDARY ENDPOINTS:
- Overall Response Rate (ORR)
- Progression Free Survival (PFS)
- Time to Progression (TTP)
- Time to next therapy
A total of 56 patients may be enrolled in this
This is a phase 1/2a trial. Since this is an AHSCT conditioning regimen trial, only one cycle of therapy will be administered for each subject.
PHASE 1 The phase 1 component has a typical 3+3 design.
- Initially up to three subjects will be enrolled in each cohort starting at cohort 0 in the table
Describe succinctly and clearly the past findings which justify the plan for this project. A summary of the relevant literature in the area of interest and reports of previous studies should be included.
For majority of lymphoma patients who relapse after complete response or who are primary
Disease background:
MM is a plasma cell tumor. It accounted for an estimated 20,180 new cases of cancer and 11,170 deaths in the United States in 2010. With a prevalence of 23 per 100,000 people, MM is an orphan disease (prevalence <5:10,000). The median age at diagnosis is 60-65 years. Although MM