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Neoplasms, Plasma Cell clinical trials

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NCT ID: NCT01946152 Terminated - Clinical trials for Recurrent Plasma Cell Myeloma

Pomalidomide, Dexamethasone, and Filgrastim-sndz in Treating Patients With Relapsed or Refractory Multiple Myeloma

Start date: March 5, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and the best dose of pomalidomide when given together with dexamethasone and filgrastim-sndz and to see how well they work in treating patients with multiple myeloma that has returned or that does not respond to treatment. Pomalidomide may stimulate or suppress the immune system in different ways and may stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Colony-stimulating factors, such as filgrastim-sndz, may increase the production of red and white blood cells and may help the immune system recover from the side effects of pomalidomide and/or dexamethasone. Giving pomalidomide together with dexamethasone and filgrastim-sndz may work better in treating patients with multiple myeloma.

NCT ID: NCT01937442 Completed - Multiple Myeloma Clinical Trials

Pharmacokinetic Study of Thalidomide in Subjects With Multiple Myeloma

Start date: November 7, 2013
Phase: Phase 1
Study type: Interventional

Objective of this study is to characterize the steady-state pharmacokinetics (PK) of thalidomide when given orally as monotherapy to subjects with multiple myeloma.

NCT ID: NCT01936532 Completed - Clinical trials for Newly Diagnosed Multiple Myeloma

Safety and Efficacy Study of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone in the Initial Management of Multiple Myeloma (IFM2013-06)

IFM2013-06
Start date: November 12, 2014
Phase: Phase 2
Study type: Interventional

This is a phase II, multicenter, open-label study to evaluate the safety and efficacy of MLN9708 in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma. The patient population will consist of adult men and women younger than 66 years, who have a confirmed diagnosis of MM who meet eligibility criteria. Following the screening period, patients will be enrolled and treated then, they will receive induction therapy (3 cycles), a systematic Peripheral Blood Stem Cell harvest. After Peripheral Blood Stem Cell Transplantation, patient will enter in the consolidation phase (early and late one) 2 months after transplantation. Finally, patients follow a Maintenance therapy (start 1 month after the last cycle of consolidation) during 12 months.

NCT ID: NCT01936090 Completed - Clinical trials for Refractory Plasma Cell Myeloma

Bortezomib, Melphalan, and Total-Body Irradiation Before Stem Cell Transplant in Treating Patients With Multiple Myeloma

Start date: August 2013
Phase: Phase 1
Study type: Interventional

This phase I/II trial studies the side effects and best dose of bortezomib when given together with melphalan, and total-body irradiation before stem cell transplant and to see how well it works in treating patients with multiple myeloma. Giving chemotherapy and total-body irradiation before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. The stem cells that were collected from the patient's blood or bone marrow are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and total-body irradiation.

NCT ID: NCT01927718 Terminated - Myeloma Clinical Trials

Thalidomide to Overcome Lenalidomide Resistance After Autologous Hematopoietic Stem Cell Transplantation (HCT)

Start date: January 2014
Phase: N/A
Study type: Interventional

The goal of this clinical research study is to learn if adding low dose Thalidomide (thalidomide) to Revlimid (lenalidomide) maintenance therapy will help control MM after an autologous stem cell transplant. Researchers also want to learn if treatment with these study drugs will improve participants' quality of life.

NCT ID: NCT01923935 Recruiting - Multiple Myeloma Clinical Trials

Busulfan and Melphalan Conditioning in Multiple Myeloma

Start date: January 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether intravenous busulfan and melphalan as a conditioning regimen is effective in the treatment of multiple myeloma undergoing autologous stem cell transplantation.

NCT ID: NCT01919619 Completed - Lymphoma Clinical Trials

Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies

Start date: November 4, 2013
Phase: Phase 2
Study type: Interventional

This pilot clinical trial studies the side effects of lenalidomide and ipilimumab after stem cell transplant in treating patients with hematologic or lymphoid malignancies. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide with ipilimumab may be a better treatment for hematologic or lymphoid malignancies.

NCT ID: NCT01919086 Completed - Clinical trials for Multiple Myeloma (MM)

Response Adapted Therapy With Bortezomib/Dexamethasone Followed by Addition of Lenalidomide in Non Responders as Initial Treatment for Patients With Multiple Myeloma

Start date: August 6, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see if researchers could get the same good results with less toxicity by using this new approach. We already know that the three drugs bortezomib, lenalidomide, and dexamethasone given together at the same time are effective. Most physicians therefore treat patients with multiple myeloma with the 3 drug combination. However, the researchers also know that the three drugs given together result in more side effects than when only 2 drugs (bortezomib and dexamethasone or lenalidomide and dexamethasone) are given. The researchers believe that all patients may not necessarily need the three drugs to have good results. In this study, the researchers will first treat your disease with bortezomib and dexamethasone. If the disease is not well controlled with these 2 drugs, only then the third drug, lenalidomide, will be added. By using this sequential approach we may reach the same good results with fewer side effects.

NCT ID: NCT01916252 Completed - Multiple Myeloma Clinical Trials

Bortezomib (Velcade®), Lenalidomide (Revlimid®) and IV Busulfan (Busilvex®) in Patients Under 65 Years Old

GEM2012MENOS65
Start date: September 2013
Phase: Phase 3
Study type: Interventional

This protocol is a national, multicenter, comparative, open-label, randomized trial comparing the progression free survival (PFS) of two pre-transplant conditioning regimens (BUMEL versus. MEL-200). A total of 460 patients will be enrolled in the study. Scheduled evaluations and study visits will take place during the pre-treatment, treatment and follow-up periods. The pre-treatment period includes the screening visit in which participants provide informed consent in writing in order to take part in the study. The patient is then assessed to determine his/her eligibility. The selection process will begin 21 days before the first dose of medication is administered (days -21 to 0). During the treatment period, eligible patients will be included in the study and given six cycles of induction treatment with bortezomib/ lenalidomide / dexamethasone (VRD-GEM). Each cycle will last 28 days, during which SC bortezomib will be administered on days 1, 4, 8 and 11, oral lenalidomide on days 1-21 of each cycle, and oral dexamethasone on days 1-4 and 9-12 of the cycle. After the first three induction cycles, and in the absence of progression or unacceptable toxicity, peripheral blood hematopoietic stem cells will be mobilized and collected using G-CSF for later autologous transplantation. Patients will be randomized in a 1:1 allocation ratio to receive conditioning treatment with MEL-200 versus BUMEL. Randomization will take place at the beginning of the study, once the screening is complete and the patient's eligibility verified. Three months after transplantation, patients will receive two cycles of consolidation treatment with VRD-GEM at the same doses administered during induction treatment. Once the treatment phase is complete, patients will begin the follow-up phase in which they will be visited every three months to evaluate disease progression and survival

NCT ID: NCT01913730 Completed - Multiple Myeloma Clinical Trials

Maintenance Therapy With Subcutaneous Bortezomib

Start date: November 2013
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, open label study designed to evaluate the efficacy and safety of prolonged treatment with bortezomib twice monthly and dexamethasone after a salvage treatment containing bortezomib for relapsed or refractory multiple myeloma patients.