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Neoplasms, Plasma Cell clinical trials

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NCT ID: NCT01248923 Completed - Clinical trials for Multiple Myeloma, Plasma Cell Leukemia

A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma

Start date: December 2010
Phase: Phase 1
Study type: Interventional

This is a Phase 1 study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL) will receive investigational study drug ARRY-520 and bortezomib, with or without dexamethasone, with granulocyte-colony stimulating factor (G-CSF) support. This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in combination with (1) bortezomib with G-CSF support or (2) bortezomib and dexamethasone with G-CSF support, in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 45 patients from the US will be enrolled in Part 1 (Active, not recruiting). In the second part of this study, patients will receive the best dose(s) and schedule(s) of study drug, in combination with bortezomib ± dexamethasone + G-CSF, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Active, not recruiting).

NCT ID: NCT01248455 Terminated - Multiple Myeloma Clinical Trials

A Phase II Trial of Anti-KIR in Smoldering Multiple Myeloma

Start date: November 1, 2010
Phase: Phase 2
Study type: Interventional

Background: - Recent studies have shown that smoldering multiple myeloma has a high risk of progressing to multiple myeloma, an aggressive type of bone marrow cancer, within 5 years of diagnosis. People with smoldering multiple myeloma have abnormal blood test results that show a high level of monoclonal protein (M-protein) in the blood and of plasma cells in the bone marrow. There are currently no known effective treatments to prevent smoldering multiple myeloma from developing into multiple myeloma, and there are no known tests for determining whether an individual with smoldering multiple myeloma will develop multiple myeloma. - Certain cells in the immune system, known as natural killer (NK) cells, are active against multiple myeloma. The experimental drug anti-killer cell immunoglobulin-like receptor (anti-KIR) has been shown to help NK cells kill multiple myeloma cells. Researchers are interested in determining whether anti-KIR can be given to individuals with smoldering multiple myeloma to improve their abnormal blood test results. Objectives: - To evaluate the safety and effectiveness of anti-KIR as a treatment for abnormal blood test results related to smoldering multiple myeloma. Eligibility: - Individuals at least 18 years of age who have been diagnosed with smoldering multiple myeloma. Design: - Participants will be screened with a physical examination and medical history, and will provide baseline blood, urine, and bone marrow samples before beginning the study drug. - Participants will receive anti-KIR intravenously for 1 hour, and will be closely monitored for 24 hours after receiving the first dose. If there are no serious side effects, participants will receive five additional anti-KIR doses, one every other month, for a total of six treatment cycles. - Participants will have monthly visits to provide additional blood and urine samples, and may have additional bone marrow biopsies as directed by the study researchers. - Participants will have followup visits every 3 to 6 months for up to 5 years after receiving anti-KIR treatment.

NCT ID: NCT01246063 Completed - Multiple Myeloma Clinical Trials

Carfilzomib, Pegylated Liposomal Doxorubicin Hydrochloride, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Start date: May 14, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this phase I/II trial is to determine the maximal tolerated dose (MTD) of carfilzomib together with pegylated liposomal doxorubicin hydrochloride (PLD) with or without dexamethasone, and then to establish the efficacy and safety of this novel combination in patients with relapsed or refractory multiple myeloma

NCT ID: NCT01245673 Completed - Myeloma Clinical Trials

Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma

Start date: May 10, 2011
Phase: Phase 2
Study type: Interventional

One purpose of this study is to find out if a new combination of immune system treatments (MAGE-A3 vaccine plus activated T-cells) will allow the body to build up protection ("immunity") against the myeloma cells. A second purpose is to find out how well this combination of immune system treatments is able to control the myeloma.

NCT ID: NCT01242930 Completed - Multiple Myeloma Clinical Trials

Open Label Study With Imetelstat to Determine Effect of Imetelstat in Patients w/ Previously Treated Multiple Myeloma

Start date: November 2010
Phase: Phase 2
Study type: Interventional

This is an open label Phase II study to determine the rate of improvement in response of patients with previously treated multiple myeloma to imetelstat alone or in combination with lenalidomide maintenance therapy. This study will include multiple myeloma patients who either have achieved disease stabilization or who have achieved at least a partial response (PR) but failed to achieve a complete response (CR) after cytoreductive therapy for multiple myeloma; ie, have detectable but non-progressing disease and will most likely relapse.

NCT ID: NCT01242267 Completed - Multiple Myeloma Clinical Trials

Escalating Doses of Thalidomide in Conjunction With Bortezomib and HIgh Dose Melphalan for BSCT

Thal/Mel/Vel
Start date: May 11, 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this study is to: • Determine the maximum tolerated dose of thalidomide used in conjunction with dose-intense melphalan, bortezomib and autologous (syngeneic) HSC support in the salvage therapy of patients who failed a prior treatment with dose-intense melphalan The secondary objectives of this study are to: - Determine the toxicities resulting from administration of combinations of thalidomide, bortezomib and melphalan - Determine the complete response (CR) and very good partial response (VgPR) rate in patients undergoing ASCT using thalidomide, bortezomib and melphalan - Evaluate the treatment-free interval after treatment with the combination of thalidomide, bortezomib and melphalan

NCT ID: NCT01241708 Completed - Multiple Myeloma Clinical Trials

Tandem Auto Stem Cell Transplant With Melphalan Followed by Melphalan and Bortezomib in Patients With Multiple Myeloma

(Mel/MelVel)
Start date: April 8, 2010
Phase: Phase 3
Study type: Interventional

High dose chemotherapy with stem cell transplantation is commonplace in the treatment of multiple myeloma. This treatment uses a chemotherapy drug called Melphalan that has been used in several thousand bone marrow transplant recipients worldwide for the same or similar disorders.

NCT ID: NCT01241396 Completed - Multiple Myeloma Clinical Trials

A Study to Record in an Observational Manner the Treatment of Multiple Myeloma as it is Being Done in Every Day Practice Without Providing Any Investigational Drug or Prescribing Any Procedure

Start date: October 2010
Phase: Phase 4
Study type: Observational

The primary objective of this observational study is to document and describe current treatment regimens and disease progression of patients with Multiple Myeloma (MMY). The aim of this registry is to provide accurate, descriptive information on the way Multiple Myeloma is treated in routine clinical practice. The registry will collect information related to the treatment received for Multiple Myeloma. About 3000 patients will take part in the study in about 28 countries. The registry will only collect information that is already in medical files regarding treatment. Patients will not be required to actively do anything in addition to what would be done without participating in this registry, nor will there be any procedures or interventions that are not already part of the current treatment.

NCT ID: NCT01241292 Completed - Multiple Myeloma Clinical Trials

Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone

Start date: January 14, 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of Elotuzumab when given in combination with Lenalidomide and low-dose Dexamethasone in subjects with relapsed or refractory multiple myeloma (MM) in Japan.

NCT ID: NCT01239797 Completed - Multiple Myeloma Clinical Trials

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

ELOQUENT - 2
Start date: June 20, 2011
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).