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A Pilot Study of the Combination of Melphalan, Bortezomib, Thalidomide and Dexamethasone (MEL-VTD)

2014-08-27 03:34:21 | BioPortfolio

Summary

In this study, researchers want to find out if using the VTD regimen, along with higher doses melphalan, in subjects who have relapsed or progressed after previous transplant(s), can be given safely to subjects who have failed previous transplant(s).

Description

Autologous transplant is now considered a standard treatment for many patients with multiple myeloma. An autologous transplant is a procedure in which stem cells are removed from a patient and then given back to the patient following intensive treatment. Doctors remove healthy stem cells from a patient's circulating blood system and store them before the patient receives high-dose chemotherapy. The stem cells are then returned to the patient, where they can produce new blood cells to replace cells destroyed by the treatment. The drug usually used before transplant is melphalan alone in 1 or 2 high doses. In past studies conducted at UAMS, researchers have shown that a chemotherapy treatment regimen called "VTD" is effective in patients with multiple myeloma who have failed previous treatments. VTD is a combination of drugs consisting of VelcadeTM (also known as bortezomib), Thalidomide, and Dexamethasone. In this study, researchers want to find out if using the VTD regimen, along with higher doses melphalan, in subjects who have relapsed or progressed after previous transplant(s) can be given safely to subjects who have failed previous transplant(s).

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Multiple Myeloma

Intervention

Melphalan, Velcade, Thalidomide, Dexamethasone

Location

University of Arkansas for Medical Sciences
Little Rock
Arkansas
United States
72205

Status

Completed

Source

University of Arkansas

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:34:21-0400

Clinical Trials [1992 Associated Clinical Trials listed on BioPortfolio]

Randomized Phase 3b Study in Previously Untreated Multiple Myeloma Patients: VELCADE,Thalidomide, and Dexamethasone Versus VELCADE and Dexamethasone Versus VELCADE, Melphalan, and Prednisone

This is a randomized, open label, multicenter clinical trial to compare the efficacy and safety of VELCADE dexamethasone versus VELCADE, thalidomide, and dexamethasone versus VELCADE, melp...

GEM05 for Patients With Multiple Myeloma Under 65 Years

The primary objective is to compare safety and efficacy of three induction treatments: VBMCP-VBAD / Velcade versus Thalidomide / Dexamethasone versus Velcade / Thalidomide / Dexamethasone....

A Study to Evaluate Two Different Regimens of VELCADE in Combination With Dexamethasone, Thalidomide and Cyclophosphamide (VDT vs VDTC) in Newly Diagnosed Multiple Myeloma

The purpose of this Phase 2 randomized study is to evaluate the efficacy and safety of treatment with a regimen of VELCADE, dexamethasone, and thalidomide (VDT) or VELCADE, dexamethasone, ...

Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma

The purpose of the study is to compare thalidomide + dexamethasone with bortezomib + dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main goal is to fi...

Multiple Myeloma Treated With Thalidomide Before Autotransplant or With Conventional Chemotherapy and as Consolidation/Maintenance Treatment in Young and Elderly Patients : 3 Randomized Studies.

The aim of the study was to evaluate efficacy and tolerability of Thalidomide in first-line treatment of multiple myeloma as induction treatment in young patients, with Dexamethasone befo...

PubMed Articles [5882 Associated PubMed Articles listed on BioPortfolio]

Comparison of two melphalan protocols and evaluation of outcome and prognostic factors in multiple myeloma in dogs.

Multiple myeloma (MM) in dogs typically is treated with melphalan. A daily melphalan dosing schedule reportedly is well tolerated and associated with favorable outcome. Although anecdotally a pulse do...

Elotuzumab and Dexamethasone for Relapsed or Refractory Multiple Myeloma Patients: A Retrospective Study.

To evaluate the efficacy and safety of elotuzumab and dexamethasone (Ed) for relapsed or refractory multiple myeloma (RRMM) patients.

An Expanded Treatment Protocol of Panobinostat Plus Bortezomib and Dexamethasone in Patients With Previously Treated Myeloma.

Panobinostat was recently approved by the US Food and Drug Administration and European Commission in combination with bortezomib and dexamethasone for patients with multiple myeloma who have received...

Symptom experience of multiple myeloma (syMMex) patients treated with autologous stem cell transplantation following high-dose melphalan: a descriptive longitudinal study.

High-dose melphalan and autologous stem cell transplantation (ASCT) are associated with high symptom burden. This study aimed to explore multiple myeloma (MM) patients' experience of symptom frequency...

Early salivary changes in multiple myeloma patients undergoing autologous HSCT.

One explorative observational study in 2 parts was performed to examine early salivary changes in relation to oral mucositis (OM) in multiple myeloma patients treated with high-dose melphalan and auto...

Medical and Biotech [MESH] Definitions

A rare, aggressive variant of MULTIPLE MYELOMA characterized by the circulation of excessive PLASMA CELLS in the peripheral blood. It can be a primary manifestation of multiple myeloma or develop as a terminal complication during the disease.

Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.

A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppresive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.

An alkylating nitrogen mustard that is used as an antineoplastic in the form of the levo isomer - MELPHALAN, the racemic mixture - MERPHALAN, and the dextro isomer - MEDPHALAN; toxic to bone marrow, but little vesicant action; potential carcinogen.

An abnormal protein with unusual thermosolubility characteristics that is found in the urine of patients with MULTIPLE MYELOMA.

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