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Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain Amyloidosis

2014-08-27 03:15:31 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of plasma cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving melphalan together with dexamethasone is more effective with or without bortezomib in treating systemic amyloidosis.

PURPOSE: This randomized phase III trial is studying melphalan and dexamethasone to see how well they work with or without bortezomib in treating patients with previously untreated systemic amyloidosis.

Description

OBJECTIVES:

Primary

- To compare hematologic overall response (partial response [PR], very good PR, amyloid complete hematologic response [ACR], and stringent complete response [sCR]) after 3 courses of therapy in patients with previously untreated systemic light-chain amyloidosis treated with melphalan and dexamethasone with vs without bortezomib.

Secondary

- To evaluate the ACR rate after 3 courses of therapy and at completion of therapy.

- To evaluate organ response rates after 3 courses of therapy and at 6, 9, and 12 months.

- To evaluate treatment-related mortality.

- To evaluate toxicity.

- To evaluate progression-free and overall survival.

- To evaluate PR or better at completion of therapy.

- To evaluate time to hematologic and organ response.

- To evaluate the duration of hematologic and organ response.

Tertiary

- To determine the prognostic impact of t(11;14) translocation and cyclin D1 overexpression on response and overall survival. (Correlative)

- To compare sCR rates and to determine the impact of sCR on the outcomes. (Correlative)

- To perform a descriptive analysis of amyloid typing and proteomic composition of amyloid tissues. (Correlative)

OUTLINE: This is a multicenter study. Patients are stratified according to cardiac stage (I vs II) and are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral melphalan and oral dexamethasone on days 1-4. Treatment repeats every 28 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive oral melphalan and oral dexamethasone on days 1-4 and bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2 courses. Patients then receive oral melphalan and oral dexamethasone on days 1-4 and bortezomib IV on days 1, 8, 15, and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Blood, urine, bone marrow, and fat samples may be collected periodically for laboratory analysis.

After completion of study treatment, patients are followed up periodically for 5 years.

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Intervention

bortezomib, dexamethasone, melphalan

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:31-0400

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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.

A pyrazine and boronic acid derivative that functions as a reversible PROTEASOME INHIBITOR. It is used as an ANTINEOPLASTIC AGENT in the treatment of MULTIPLE MYELOMA and MANTLE CELL LYMPHOMA.

Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.

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.

A malignancy of mature PLASMA CELLS engaging in monoclonal immunoglobulin production. It is characterized by hyperglobulinemia, excess Bence-Jones proteins (free monoclonal IMMUNOGLOBULIN LIGHT CHAINS) in the urine, skeletal destruction, bone pain, and fractures. Other features include ANEMIA; HYPERCALCEMIA; and RENAL INSUFFICIENCY.

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