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Multiple Myeloma clinical trials

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NCT ID: NCT00343798 Completed - Clinical trials for Recurrent Mantle Cell Lymphoma

A Pilot Study to Evaluate the Co-Infusion of Ex Vivo Expanded Cord Blood Cells With an Unmanipulated Cord Blood Unit in Patients Undergoing Cord Blood Transplant for Hematologic Malignancies

Start date: April 2006
Phase: Phase 1
Study type: Interventional

This phase I multicenter feasibility trial is studying the safety and potential efficacy of infusing ex vivo expanded cord blood progenitors with one unmanipulated umbilical cord blood unit for transplantation following conditioning with fludarabine, cyclophosphamide and total body irradiation (TBI), and immunosuppression with cyclosporine and mycophenolate mofetil (MMF) for patients with hematologic malignancies. Chemotherapy, such as fludarabine and cyclophosphamide, and TBI given before an umbilical cord blood transplant stops the growth of leukemia cells and works to prevent the patient's immune system from rejecting the donor's stem cells. The healthy stem cells from the donor's umbilical cord blood help the patient's bone marrow make new red blood cells, white blood cells, and platelets. It may take several weeks for these new blood cells to grow. During that period of time, patients are at increased risk for bleeding and infection. Faster recovery of white blood cells may decrease the number and severity of infections. Studies have shown that counts are more likely to recover more quickly if increased numbers of cord blood cells are given with the transplant. We have developed a way of growing or "expanding" the number of cord blood cells in the lab so that there are more cells available for transplant. We are doing this study to find out whether or not giving these expanded cells along with one unexpanded cord blood unit is safe and if use of expanded cells can decrease the time it takes for white blood cells to recover after transplant. We will study the time it takes for blood counts to recover, which of the two cord blood units makes up the patient's new blood system, and how quickly immune system cells return

NCT ID: NCT00339963 Completed - Multiple Myeloma Clinical Trials

Genome Expression in Lymphoma, Leukemia and Multiple Myeloma

Start date: November 9, 2001
Phase:
Study type: Observational

This study will use genomics-based technology, such as DNA microarrays, to more precisely diagnose subsets of lymphoma, leukemia and multiple myeloma patients. There have been many attempts to classify lymphoid cancers in ways that will be useful for clinical diagnosis and treatment. Although broad diagnostic categories have been reliably defined, patients within each category have distinct clinical courses, suggesting that these classifications could be further divided into molecular (genetic) subtypes. For example, 40 percent of patients with diffuse large B-cell lymphoma achieve long-term disease remissions following combination chemotherapy and are apparently cured, whereas the remaining 60 percent die from the disease. Similarly, some patients with follicular lymphoma develop aggressive disease within a few years of diagnosis, while others have stable disease over 10 to 20 years. Although the distinctions in clinical course of these diseases are recognized, there are no studies to determine the molecular (genetic) basis for this variability. This study will try to define new molecular diagnostic categories in these diseases and correlate them with clinical features, including treatment response, disease remission and overall survival following chemotherapy. This retrospective study will use clinical data and tissue samples from participating centers in the Lymphoma/Leukemia Molecular Profiling Project LLMPP). New patients will not be recruited for this study. Biopsy materials, including fresh frozen or OTC-embedded lymphoma biopsy material, viably frozen samples of peripheral blood cells from leukemia patients, and viably frozen samples of bone marrow aspirates from multiple myeloma patients will be collected from pathologists participating in the LLMPP. RNA and genomic DNA will be extracted from the tumor samples. A variety of technologies will be used to characterize the genome of the cancer cells, including lymphochip microarrays for array-based comparative genomic hybridization; Southern blotting and PCR for translocation of genes previously implicated in these malignancies; and PCR and DNA sequencing methods for analyzing base changes in the genome of the cancer cells. Clinical information from the initial diagnosis to disease relapse will be taken from existing databases and/or patient charts. Gene expression will be correlated with the clinical data. If a small number of genes is found to strongly predict clinical outcome, quantitative RT-PCR assays using the Taqman technology may be developed as an alternative to DNA microarray analysis. ...

NCT ID: NCT00335647 Completed - Clinical trials for Multiple Myeloma and Plasma Cell Neoplasm

Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma

Start date: January 2006
Phase: Phase 1/Phase 2
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as fluphenazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I/II trial is studying the side effects and best dose of fluphenazine and to see how well it works in treating patients with refractory advanced multiple myeloma.

NCT ID: NCT00335348 Completed - Multiple Myeloma Clinical Trials

Bortezomib and Dexamethasone as Treatment and Maintenance for Multiple Myeloma Relapse

Start date: June 2006
Phase: Phase 2
Study type: Interventional

This study has two main aims. The first is to assess whether Dexamethasone can increase the number of patients with who respond to Velcade. The second aim of this study is to see whether treating patients with relapsed multiple myeloma with Velcade and Dexamethasone for a longer period of time extends the time that the myeloma is under control.

NCT ID: NCT00333190 Completed - Multiple Myeloma Clinical Trials

CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation

Start date: September 2005
Phase: N/A
Study type: Interventional

The purpose of this trial is to determine if selectively removing only a small subset of T cells, called CD8+ T cells, is safe and if it can reduce the risk of graft versus host disease (GVHD) without losing the anti-cancer effects.

NCT ID: NCT00330759 Completed - Bone Metastases Clinical Trials

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.

Start date: June 1, 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)

NCT ID: NCT00327249 Completed - Multiple Myeloma Clinical Trials

Safety and Efficacy Study of Imexon for Treatment of Multiple Myeloma Patients

Start date: October 2005
Phase: Phase 1/Phase 2
Study type: Interventional

AMP-007 is a Phase 1/2 study for the treatment of advanced, previously treated multiple myeloma. The first phase of the study is designed to determine a safe dose of imexon that can be given to patients with advanced, previously-treated multiple myeloma. The Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether imexon can improve the outcome for patients with multiple myeloma

NCT ID: NCT00325416 Completed - Multiple Myeloma Clinical Trials

Study of Melphalan and Topotecan (MT) Followed by Autologous Stem Cell Rescue in Patients With Multiple Myeloma.

Start date: November 19, 2001
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this research study is to determine the safest dose of topotecan when given in a high dose before a stem cell transplant; topotecan will be given with melphalan.

NCT ID: NCT00323505 Completed - Multiple Myeloma Clinical Trials

A Phase II Trial Comparing the Quality of Life, Tolerability and Toxicity of PEG Intron With INTRON® A in Patients With Multiple Myeloma

Start date: March 2001
Phase: Phase 2
Study type: Interventional

Multiple myeloma is a rare form of malignancy in which neoplastic plasma cells accumulate in the bone marrow. Most malignant plasma cells continue to produce immunoglobulin. The activity of multiple myeloma can therefore usually be monitored easily by serial measurement of the serum paraprotein levels. Except for a few patients who receive a donor bone marrow transplant, multiple myeloma remains incurable despite intensive chemotherapy. Its course is typically marked by periods of active disease alternating with increasingly shorter remissions. Interferons are substances produced in human cells in response to a variety of stimuli, such as viral infection. When given to myeloma patients as part of maintenance treatment , interferon-alpha 2 b (INTRONA) has been shown to be of value in prolonging the periods of remission. Until now, INTRONA could only be given as injections under the skin, three times a week. Some patients experience flu-like symptoms with each injection, particularly early on during maintenance therapy. This, as well as the chronic fatigue and even depression that INTRONA can induce may considerably reduce the quality of life of myeloma patients on interferon, so much so that sometimes this useful adjunct to chemotherapy for myeloma has to be stopped. Recently, a new preparation of interferon namely pegylated interferon (PEG Intron) has become available. It has the advantage of being broken down much more slowly by the body and therefore only needs to be given once a week. This minimises the swings in blood interferon levels that may be responsible for some of the interferon side effects. The safety and superior tolerability of PEG Intron has already been demonstrated in patients with hepatitis C for which it now carries a licence, but not in myeloma patients. Here, we propose to study whether the quality of life and side effect profile of myeloma patients on PEG Intron is better compared to that of Intron®A. In the main study, consenting eligible myeloma patients who are well and have been established on INTRONA maintenance therapy for at least six weeks will be randomly allocated to receive PEG Intron for three months followed by INTRONA for 3 months, or to continue with INTRONA for 3 months followed by PEG Intron for 3 months. All patients will be monitored regularly for any side effects and will be asked to fill in a quality of life questionnaire at the beginning (i.e. before receiving the first randomised treatment) and at the end of each study period (i.e. at 3 and 6 months). Initially, we are aiming at enrolling 60 patients into this part of the study. In a smaller sub-study involving only 14 patients initially, we are proposing to investigate whether myeloma patients who need to be taken off Intron®A because of its side effects can tolerate PEG Intron more easily. Should their tolerance of PEG Intron also be poor we would stop the interferon maintenance therapy altogether. However, should PEG Intron be found to be acceptable to them, we intend to switch these patients back to the standard treatment at the end of six weeks treatment with PEG Intron to assess whether they have become more tolerant of Intron®A in the intervening period. Patients will again be monitored carefully for any side effects and will be asked to fill in three quality of life questionnaires (at 0, 6 and 12 weeks).

NCT ID: NCT00322842 Completed - Multiple Myeloma Clinical Trials

Treatment With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients

Start date: September 2004
Phase: Phase 2
Study type: Interventional

This study evaluates the safety of plerixafor and other outcomes that are purely exploratory in nature. One other pre-specified outcome is to evaluate an interval of 10-11 hours between dosing with plerixafor and the beginning of apheresis to determine if there will be at least a 2-fold increase in circulating CD34+ cells. Data from this protocol will assist in the determination of the dosing schedule for future studies.