Clinical Trial: First-line Pomalidomide, Bortezomib, and Dexamethasone For AL Amyloidosis or LCDD

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: Phase I Study of Pomalidomide, Bortezomib, and Dexamethasone (PVD) as First-Line Treatment of AL Amyloidosis or Light Chain Deposition Disease

Brief Summary: This phase I trial studies the side effects and best dose of pomalidomide and bortezomib when given together with dexamethasone in treating patients with amyloid light-chain amyloidosis or light chain deposition disease. Biological therapies, such as pomalidomide, may stimulate the immune system in different ways and stop abnormal cells from growing. Bortezomib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth. Giving pomalidomide and bortezomib together with dexamethasone may be an effective treatment for amyloid light-chain amyloidosis or light chain deposition disease

Detailed Summary:

PRIMARY OBJECTIVES:

I. Establish the maximum tolerated dose (MTD) of the combination of pomalidomide, bortezomib, and dexamethasone (PVD) to take forward in a subsequent phase 2 study.

SECONDARY OBJECTIVES:

I. Obtain a preliminary assessment of efficacy of PVD regimen as initial treatment of amyloid light-chain (AL) or light chain deposition disease (LCDD).

OUTLINE: This is a dose-escalation study of pomalidomide and bortezomib.

Patients receive pomalidomide orally (PO) on days 1-21; bortezomib intravenously (IV) on days 1, 8, and 15; and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at least every 3 months.


Sponsor: Barbara Ann Karmanos Cancer Institute

Current Primary Outcome: Maximum tolerated dose defined as the dose level before 2 of 6 patients experience dose-limiting toxicity (DLT) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: 28 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Complete hematologic response rate (hCR) [ Time Frame: Up to 28 days ]
    Will be estimated and reported with 95% confidence intervals.
  • Overall hematologic response rate (partial response [PR] + complete response [CR]) [ Time Frame: Up to 28 days ]
  • Organ response rates (heart, liver, kidney) [ Time Frame: Up to 28 days ]
    Organ responses will be tabulated and reported for all patients with cardiac, renal, hepatic, and/or neurologic involvement by amyloidosis.
  • Overall survival [ Time Frame: From date of registration to date of death, assessed up to 28 days ]
    Will be estimated and reported with 95% confidence interval.
  • Progression free survival [ Time Frame: Up to 28 days ]
    Will be estimated and reported with 95% confidence interval.


Original Secondary Outcome: Same as current

Information By: Barbara Ann Karmanos Cancer Institute

Dates:
Date Received: November 13, 2012
Date Started: March 2013
Date Completion: June 2017
Last Updated: April 5, 2017
Last Verified: March 2017