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Clinical trials

AL AMYLOIDOSIS TRANSPLANTATION TRIALS

Phase II Trial Evaluating Modified High Dose Melphalan (100 Mg/M2) And Autologous Stem Cell Transplantation For Patients with AL amyloidosis or High Risk Patients with Multiple Myeloma (A Bone Marrow Transplant Study): SWOG #S0115:

Principal Investigator: Dr. Vaishali Sanchorawala

This is an NCI-Sponsored National Cooperative Group trial evaluating two cycles of modified high dose chemotherapy and autologous stem cell transplantation. The protocol was activated nationally on 1/1/04. National accrual goal is 100 subjects; accrual to date is 32.

Phase II Trial of Second Autologous Transplantation in AL Amyloidosis

Principal Investigator: Dr. Karen Quillen

This study is a BMC trial for patients who have persistent disease or have relapsed after a first course of high-dose chemotherapy. Prior stem cell yield must be > 2 x 106 CD34+ cells/kg. Patients must have had acceptable toxicity and significant initial improvement in organ function with first course and must not have had chemotherapy after the first transplant. The accrual goal is 19 patients.

AL AMYLOIDOSIS NON-TRANSPLANTATION STUDIES

Velcade: An Open-Label, Phase I/II Study of VELCADE (bortezomib) for injection in Subjects with Light Chain Amyloidosis

Principal Investigator: Dr. Vaishali Sanchorawala

This study is an international, multi-center protocol sponsored by Millenium Pharmaceuticals and Johnson and Johnson. The total accrual goal is 66 patients. Candidates must have failed at least one previous treatment and (in the opinion of the investigator) require further treatment. If prior therapy includes high-dose chemotherapy and stem cell transplantation, it must have been more than 6 months prior to enrollment.

Phase II Trial of the Immunomodulatory Drug CC-5013 (Revlimid) for Patients with AL Amyloidosis

Principal Investigator: Dr. David C. Seldin

This study, designed to determine the toxicity and hematologic response rate to the immunomodulatory drug CC-5013 (Revlimid, or lenalidomide), in AL amyloidosis patients, is currently closed to accrual. This study was sponsored by the manufacturer, Celgene, Inc.

Phase II Trial Evaluating The Effects Of Antioxidants On Cardiac Function In Patients With AL Amyloidosis And Cardiac Involvement.

Principal Investigator: Dr. Michael Rosenzweig

A pilot study in the process of recruiting patients to be randomized into either a treatment group receiving vitamin E and vitamin C or placebo for three months. BNP is the primary endpoint and echocardiogram, troponin I and F2 isoprostane level as measure of oxidative stress will serve as secondary endpoints.

ATTR AMYLOIDOSIS

Phase III Trial of the Effect of Diflunisal on Familial (ATTR) Amyloidosis.

Principal investigator: Dr. John L. Berk

The Diflunisal Trial is an international, multi-center study examining the effect of a non-steroidal anti-inflammatory drug (diflunisal or Dolobid®) on the progression of peripheral neuropathy over 2 years in patients with familial amyloidotic polyneuropathy (FAP). Candidates must have nerve changes in their legs detectable by a trained neurologist or blood pressure changes with standing. Liver transplant recipients are not eligible. The planned accrual is 200 patients.

Boston University, Mayo Clinic Rochester, and sites in Italy, Japan and Sweden are open to enrollment.

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Boston University | Amyloid Treatment & Research Program | August 8, 2007