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Neoplasms, Plasma Cell clinical trials

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NCT ID: NCT00665314 Completed - Multiple Myeloma Clinical Trials

Evaluation of the Safety and Efficacy of the Addition of AMD3100 to a G-CSF Mobilization Regimen in Patients With Lymphoma (NHL and HD) and Multiple Myeloma (MM).

Start date: November 2007
Phase: Phase 2
Study type: Interventional

Some patients with multiple myeloma or lymphoma will need treatment with high dose chemotherapy to treat their condition. This potent treatment will kill many of the blood-forming cells in the bone marrow. The patient will therefore need these blood-forming cells replaced after the chemotherapy treatment. This is done by collecting some of teh patients own blood-forming stem cells before chemotherapy, storing them and then infusing them into the patient after chemotherapy (in the same way as a blood transfusion is given). The stem cells will then make their way unto the bone marrow and re-populate it. Having stem cells collected and returned later is called an "Autologous Transplant". In most patients these blood-forming stem cells (which normally live in the bone marrow) are "mobilized" into the blood stream where they are then collected by a process called apheresis (a bit like donating blood). This process of mobilization is not always successful. In this study patients who did not collect enough stem cells in a previous cell collection attempt to have an autologous stem cell transplant will participate. Patients will be mobilized with G-CSF (current standard treatment to mobilize stem cells) and the effect of adding AMD3100 to G-CSF will be studied by comparing outcomes in patients who get G-CDF with placebo (non-active substance which looks like AMD3100) to patients who get G-CSF with AMD3100. AMD3100 is a member of a new class of medications called "chemokine inhibitors". The drug triggers the movement of stem cells out of the bone marrow into the blood stream. In previous studies with healthy volunteers and cancer patients, when AMD3100 and G-CSF were used in combination, a greater number of stem cells were mobilized into the blood stream than by using g-CSF alone. The purposes of this study are to measure how many stem cells can be collected, the number of days to collect those cells and the safety of a mobilization regimen of AMD3100 with G-CSF compared to G-CSF with placebo. If enough cells are collected to have a transplant, the study will also evaluate how well the cells grow when transplanted.

NCT ID: NCT00664898 Completed - Multiple Myeloma Clinical Trials

A Study of the Safety and Pharmacology of SGN-40 Administered in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma

Start date: May 2008
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, Phase Ib study to be conducted at approximately eight sites in Europe and the U.S. designed to evaluate the safety, pharmacokinetics, and activity of SGN-40 when combined with bortezomib in patients with multiple myeloma that is relapsed or refractory after at least one prior systemic treatment regimen.

NCT ID: NCT00661999 Completed - Lymphoma Clinical Trials

Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer

Start date: January 2006
Phase: Phase 3
Study type: Interventional

RATIONALE: Darbepoetin alfa may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether giving darbepoetin alfa (DA) together with intravenous iron or oral iron is more effective than giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy. PURPOSE: This randomized phase III trial is studying giving darbepoetin alfa together with iron to see how well it works compared with giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy in patients with cancer.

NCT ID: NCT00661544 Completed - Multiple Myeloma Clinical Trials

Arsenic Trioxide With Ascorbic Acid and Melphalan for Myeloma Patients

Start date: March 2004
Phase: Phase 1/Phase 2
Study type: Interventional

1. To evaluate the toxicity and safety of a combination of arsenic trioxide with ascorbic acid and high-dose Melphalan in patients with multiple myeloma 2. To evaluate the efficacy of a combination of arsenic trioxide with ascorbic acid and high-dose Melphalan in patients with multiple myeloma 3. To determine the effects of arsenic trioxide on melphalan pharmacokinetics

NCT ID: NCT00657488 Completed - Multiple Myeloma Clinical Trials

Thalidomide 100 mg/Day Versus Thalidomide 400 mg/Day in Relapse Refractory Multiple Myeloma

Start date: December 1, 2001
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of this study is to show that thalidomide at a dose of 100 mg/d (with remedial treatment with dexamethasone if a progression occurs) is equivalent in terms of efficacy with thalidomide at 400 mg/d (with remedial treatment with dexamethasone if a progression occurs) in the treatment of refractory or relapsed multiple myeloma after at least two courses of treatment. The use of thalidomide at 100 mg/d should reduce the side effects and improve the safety of the treatment.

NCT ID: NCT00656305 Completed - Multiple Myeloma Clinical Trials

ExAblate (MRgFUS) Treatment of Metastatic Bone Tumors for the Palliation of Pain

Start date: March 2008
Phase: N/A
Study type: Interventional

A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic Bone and Multiple Myeloma Tumors for the Palliation of Pain in Patients Who are not Candidates for Radiation Therapy

NCT ID: NCT00652041 Completed - Multiple Myeloma Clinical Trials

Bortezomib/Adriamycine/Melfalan/Prednisone (VAMP)/Thalidomide/Cyclophosphamide/Dexamethasone (TaCyDex) or Bortezomib/Melfalan/Prednisone (V-MP)/TaCyDex) in Refractary or Relapsed Multiple Myeloma

TaCyDexVMP7
Start date: January 2007
Phase: Phase 4
Study type: Interventional

Multicentric study, open, single arm, designed to evaluate the efficacy(response rate and response duration) and security of a sequential scheme of treatment with Bortezomib in combination with Melfalan and Prednisone (V-MP) (patients > 75 years) or Bortezomib and Adriamycine in combination with Melfalan and Prednisone (VAMP) (patients <= 75 years) follow by Thalidomide in combination with Cyclophosphamide and Dexamethasone (TaCyDex) in patients with refractary or relapse multiple myeloma.

NCT ID: NCT00651937 Completed - Multiple Myeloma Clinical Trials

Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden

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

The goal of this clinical research study is to learn whether higher doses of stem cells can help to decrease the symptoms that occur after melphalan. Another goal of the study is to see how the dose of infused stem cells affects the levels of certain proteins in your blood. Researchers also want to learn how the dose of stem cells that you receive affects the quality of your life during the weeks after the transplant procedure.

NCT ID: NCT00642954 Completed - Clinical trials for Relapsed or Refractory Multiple Myeloma

Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074)

Start date: February 13, 2008
Phase: Phase 1
Study type: Interventional

The purpose of this Phase I study of vorinostat in combination with lenalidomide and dexamethasone in participants with relapsed or refractory multiple myeloma is to determine the maximum tolerated dose (MTD) as estimated by the incidence of dose-limiting toxicities (DLTs) and recommended Phase 2 dose (RP2D) as estimated by the incidence of drug-related adverse events (AEs).

NCT ID: NCT00642395 Completed - Multiple Myeloma Clinical Trials

Velcade®-Melphalan Association in Autologous Stem-Cell Transplantation (ASCT)

Start date: July 2007
Phase: Phase 2
Study type: Interventional

Intensification with autologous stem cell (ASCT) is currently the most effective treatment for subjects under 65 and the essential goal is to achieve complete response (CR) or very good partial response (VGPR= greater than 90% reduction of monoclonal component). However, only 50% of patients achieve this CR/VGPR even with tandem ASCT early in the course of disease. Optimization of the conditioning regimen could improve this CR/VGPR rate. The combinaison of Velcade and HD Melphalan has never been evaluated. However, at conventional doses, Velcade potentiates the antimyeloma effect of Melphalan without inducing any common toxicity. This study will be conducted in patients under the age of 65 with de novo multiple myeloma or in first relapse, with Salmon and Durie stage of III, II, I with one symptomatic bone lesion (radiological)and no contraindication to intensification. The primary objective will be to increase the CR/VGPR rate 3 months after autologous peripheral blood stem cell transplantation conditioned by Velcade-Melphalan from 40% to 70%. With alpha=5% and bêta=10%, 61 patients will be included. Secondary objectives will be to assess the toxicity of the Velcade-Melphalan conditioning regimen, the progression-free survival and the overall survival after intensification. Response rates will be evaluated according to the response criteria defined by. Analysis will be performed on an intention-to-treat basis. After conventional induction therapy and PBSC collection, patients will be offered this new conditioning regimen. they will be free to refuse this regimen, in which case they will receive standard intensification therapy by Melphalan 200 mg/m² followed by autologous stem cell transplantation. Evaluation will occur at 3 months post intensification.