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Myeloma clinical trials

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NCT ID: NCT00907452 Completed - Myeloma Clinical Trials

Pharmacogenomic Study in Myeloma Patients Treated With Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone

Start date: July 29, 2009
Phase: N/A
Study type: Interventional

This protocol (in patients aged 65 and over suffering from previously untreated multiple myeloma), represents the first worldwide, pharmacogenomic study on this scale in terms of the number of patients analyzed and the implemented molecular diagnostics resources. The goal is to be able to identify patients who will best respond to the study treatments or experience the fewest associated side effects and improve prognosis, in order to optimize care management in multiple myeloma. To this end, the study seeks to predict the following parameters in these patients: - The treatment response and occurrence of adverse events linked to a lenalidomide-dexamethasone combination or a melphalan-prednisone-thalidomide combination. - Progression-free survival and overall survival. Prediction of the treatment response and the occurrence of adverse effects will be based on: - An analysis of constitutive genetic traits linked to single nucleotide polymorphisms and DNA copy number variations. - An analysis of changes in the tumor's genotype (change in the DNA copy number) and phenotype (altered gene and micro-RNA expression). Prediction of progression-free survival and overall survival will be based on an analysis of changes in the tumor's genotype and phenotype.

NCT ID: NCT00891618 Completed - Lymphoma Clinical Trials

Acupuncture for Chemo-Induced Peripheral Neuropathy

Start date: April 2009
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if giving acupuncture to patients with lymphoma or a plasma cell dyscrasia can help to relieve numbness and/or tingling of the feet and/or hands that is related to chemotherapy.

NCT ID: NCT00881920 Recruiting - Lymphoma Clinical Trials

Kappa-CD28 T Lymphocytes, Chronic Lymphocytic Leukemia, B-cell Lymphoma or Multiple Myeloma, CHARKALL

CHARKALL
Start date: July 2009
Phase: Phase 1
Study type: Interventional

Patients have a type of cancer called NHL, Multiple Myeloma (MM) or CLL that has come back or has not gone away after treatment. There is no standard treatment for the cancer at this time or the currently used treatments do not work completely in all cases like these. This is a gene transfer research study using special immune cells. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting disease, antibodies and T cells, that investigators hope will work together. Antibodies are types of proteins that protect the body from bacterial and other diseases. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells. Both antibodies and T cells have been used to treat patients with cancers; they have shown promise, but have not been strong enough to cure most patients. The antibody used in this study recognizes a protein on the lymphoma, MM or CLL cells called kappa immunoglobulin. Antibodies can stick to lymphoma, MM or CLL cells when it recognizes the kappa molecules present on the tumor cells. For this study, the kappa antibody has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These chimeric receptor-T cells seem to kill some of the tumor, but they don't last very long and so their chances of fighting the cancer are limited. In the laboratory, investigators found that T cells work better if they also add a protein that stimulates T cells to grow called CD28. By joining the anti-kappa antibody to the T cells and adding the CD28, the investigators expect to be able to make cells that will last for a longer time in the body (because of the presence of the CD28). They are hoping this will make the cells work better. Previously, when patients enrolled on this study, they were assigned to one of three different doses of the kappa-CD28 T cells. We found that all three dose levels are safe. Now, the plan is to give patients the highest dose that we tested. These chimeric T cells (kappa-CD28) are an investigational product not approved by the FDA.

NCT ID: NCT00871013 Active, not recruiting - Myeloma Clinical Trials

Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy

Start date: March 2009
Phase: Phase 2
Study type: Interventional

There have been four previous Total Therapy (TT1 through IIIB) studies for multiple myeloma at the MIRT from 1989 to present. Results have shown that participants treated on these studies had better outcomes (meaning they have lived longer and had better responses to treatment) when compared to individuals treated with standard chemotherapy. Past studies conducted at the MIRT have shown that participants presenting to MIRT who have already received treatment for myeloma tend to have shorter remissions (disappearance of signs and symptoms of myeloma) and do not survive as long as participants who come to MIRT with untreated myeloma. Researchers at MIRT think that one reason for this is may be that the myeloma cells re-grow in the time when participants are not receiving treatment because they are recovering from high-dose chemotherapy. In this study, participants will receive several chemotherapy drugs previously shown to be effective in myeloma, but in lower doses and in shorter cycles. It is hoped that by giving the drugs in this way, myeloma cells will not have time to re-grow between cycles, therefore resulting in longer remissions. This study is being done in an attempt to improve the remission rate and the survival time for participants with high-risk myeloma.

NCT ID: NCT00800839 Completed - Lymphoma Clinical Trials

Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide

Start date: September 2008
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if cyclophosphamide given after busulfan and fludarabine can help to prevent graft versus host disease (GVHD - a condition in which transplanted tissue attacks the body into which it is transplanted) in patients receiving a stem cell transplant. The safety of this drug combination will also be studied.

NCT ID: NCT00794261 Completed - Lymphoma Clinical Trials

Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma

PALM
Start date: September 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and tolerance of a single administration of Pegfilgrastim in patients with lymphoma or myeloma receiving high-dose chemotherapy and autologous peripheral stem cell support, and to estimate the costs incurred. Eligible patients will be randomized. The estimated inclusion period is approximately 18 months. The duration of the research is 22 months. The maximum duration of participation for each patient is 3 months. The number of patients required in this multicentric and prospective study is 150 (13 participating centers). This is a phase II, controlled, randomized, non comparative and open-label multicentric study.

NCT ID: NCT00698776 Completed - Myeloma Clinical Trials

Combination of Lenalidomide and Autologous Mature Dendritic Cells Pulsed With KRN7000 in Myeloma

Start date: April 2009
Phase: Phase 1
Study type: Interventional

This is a single arm open label trial to test the tolerability of the combination of monocyte derived DCs loaded with KRN7000 (DC-KRN7000) and Lenalidomide (LEN) in patients with asymptomatic myeloma. Phase I component of the study will evaluate the optimal dose of LEN, with particular emphasis on safety. After an interim analysis of these data, a single dose level will be chosen for phase II component in additional patients.

NCT ID: NCT00660166 Completed - Lymphoma Clinical Trials

Human Leukocyte Antigen (HLA) Class I Haplotype Mismatched Natural Killer Cell Infusions

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

The purpose of this research study is to examine the safety of infusing escalated doses of allogeneic (from a relative of the patient), enriched natural killer (NK) cells after autologous (from the patient) stem cell transplantation. The hypothesis is that the infusion of these NK cells early after an autologous stem cell transplant will help to eliminate and eradicate any residual cancerous cells that remain in the body and may have survived the chemotherapy or radiation.

NCT ID: NCT00606437 Completed - Lymphoma Clinical Trials

Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants

Start date: September 2005
Phase: Phase 1
Study type: Interventional

Results to date of umbilical cord blood transplantation in adult and fully mature adolescent patients are inferior to what is seen in children, due to a lower stem cell dosage in adults and a more toxic conditioning regimen. This phase 1 protocol will use a potentially less toxic bone marrow conditioning regimen, followed by infusion of a combined umbilical cord blood graft that will provide the patient with a higher stem cell dose than can be given with a single umbilical cord blood infusion. The subjects will be conditioned with a total body irradiation (TBI) 13.5 Gy and fludarabine. Following conditioning, up to two unrelated, partially matched umbilical cord blood grafts will be infused that will provide a minimum nucleated cell dose of 3 x 10e7/kg . The primary objective of this study is to measure the frequency of treatment-related toxicity and engraftment.

NCT ID: NCT00597714 Completed - Leukemia Clinical Trials

Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplant

Start date: February 2008
Phase: Phase 2
Study type: Interventional

The central hypothesis of this study is that use of a less toxic chemotherapy preparative regimen for allogeneic hematopoietic stem cell transplantation in combination with T cell depletion with alemtuzumab for patients with high risk hematologic malignancies will allow effective control of disease and improved disease free and overall survival compared with historical expectations. Specifically, the objectives are to estimate toxicity, disease free, progression free, event free, and overall survival rates in patients treated with alemtuzumab T cell depleted, reduced intensity preparative regimen followed by allogeneic hematopoietic transplantation; evaluate immune recovery following this reduced intensity allogeneic immunotherapy; develop an in vitro assay to allow patient individualized targeted dosing.