Clinical Trial: Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Multicenter Phase II Trial of Bortezomib (Velcade), Melphalan, and Dexamethasone (V-MD) in Patients With Symptomatic AL-Amyloidosis or Light Chain Deposition Disease

Brief Summary:

RATIONALE: Giving bortezomib together with melphalan and dexamethasone may be an effective treatment for primary amyloidosis and light chain deposition disease.

PURPOSE: This phase II trial is studying how well giving bortezomib together with melphalan and dexamethasone works in treating patients with primary amyloidosis or light chain deposition disease.


Detailed Summary:

OBJECTIVES:

Primary

  • Determine the complete hematologic response rate at 12 months.

Secondary

  • Determine the overall hematologic response rate.
  • Determine the organ response rate.
  • Determine time to treatment failure.
  • Assess toxicity of the regimen, in terms of incidence and severity of treatment-emergent peripheral neuropathy and quality of life.
  • Determine the overall survival.

OUTLINE: This is a multicenter study.

Patients receive oral melphalan on days 1-4, bortezomib IV on days 1, 8, 15, and 22, and dexamethasone orally or IV on days 1, 2, 8, 9, 15, 16, 22, and 23. Treatment repeats every 4-6 weeks for up to 20 courses in the absence of disease progression or unacceptable toxicity.

Blood, urine, and bone marrow aspirates are collected at baseline and periodically after treatment to permit the correlation of clinical results with measured molecular events. A single baseline peripheral blood DNA sample is collected for future association studies linking disease onset, progression, and response to administered therapy with single nucleotide polymorphisms. Blood plasma and urine samples are evaluated for proteomic markers associated with disease progression and therapeutic response. Peripheral blood RNA samples are evaluated for transcriptional response to treatment of peripheral blood lymphocytes. Bone marrow aspirates are collected to extract plasma cells by flow cy
Sponsor: Barbara Ann Karmanos Cancer Institute

Current Primary Outcome: Complete Hematologic Response [ Time Frame: Up to 12 months ]

Original Primary Outcome: Complete Hematologic Response

Current Secondary Outcome:

  • Overall Survival [ Time Frame: Day 1 of Each Cycle and every 12 weeks after last treatment cycle ]
  • Time to Treatment Failure [ Time Frame: Day 1 of Each Cycle ]
  • Change in Quality of Life From Baseline as Assessed by the Functional Assessment of Cancer Therapy-Neurotoxicity Questionnaire. [ Time Frame: At the start of each cycle ]
  • Organ Response Rate (OrR) [ Time Frame: Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study. ]
  • Toxicity, Including Neurotoxicity [ Time Frame: Day 1 of Each Cycle ]
  • Overall Hematologic Response Rate (OHR) [ Time Frame: Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study. ]


Original Secondary Outcome:

  • Survival
  • Time to Treatment Failure
  • Quality of life as assessed by the Functional Assessment of Cancer Therapy-Neurotoxicity questionnaire at the beginning of each course


Information By: Barbara Ann Karmanos Cancer Institute

Dates:
Date Received: August 24, 2007
Date Started: September 2007
Date Completion: December 2017
Last Updated: April 5, 2017
Last Verified: April 2017