Clinical Trials

4 studies in Amyloid

1. Efficacy and Safety Study of KIACTA in Preventing Renal Function Decline in AA Amyloidosis Rochester, MN View Summary
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   Efficacy and Safety Study of KIACTA in Preventing Renal Function Decline in AA Amyloidosis

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The primary purpose of this study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA Amyloidosis.

   NCT ID:

   NCT01215747

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   Who can I contact for additional information about this study?

   Rochester: Tammy Evans 507-284-1004
                       
   
   
   

2. Long-term Outcomes of Patients With Primary Amyloidosis After Stem Cell Transplantation Rochester, MN View Summary
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   Long-term Outcomes of Patients With Primary Amyloidosis After Stem Cell Transplantation

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   1. How does age at diagnosis affect prognosis in primary amyloidosis? 2. How do lab values at diagnosis such as Creatinine, AST/ALT, total serum protein, serum gamma globulin/immunoglobulin levels affect prognosis in primary amyloidosis? 3. How does degree of organ involvement/number of organs involved affect prognosis in primary amyloidosis? 4. How does initial treatment affect prognosis in primary amyloidosis? 4. How do the specifics the stem cell transplant protocol affect prognosis in primary amyloidosis?

   NCT ID:

   NCT01606280

   IRB Number:

   11-005003

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   Who can I contact for additional information about this study?

   Rochester: Moire Gertz, MD 507-284-3725
                       
   
   
   

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3. Study of Dexamethasone Plus MLN9708 or Physician's Choice of Treatment in Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis Scottsdale and Phoenix, AZ Rochester, MN View Summary
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   Study of Dexamethasone Plus MLN9708 or Physician's Choice of Treatment in Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

   Location:

   Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   This is a phase 3, randomized, controlled, open-label, multicenter study of the oral formulation of dexamethasone plus MLN9708 compared with treatment chosen by the investigator from a prespecified list of regimens available in clinical practice. Treatment options will include: dexamethasone alone, dexamethasone plus an alkylating agent (melphalan or cyclophosphamide), or dexamethasone plus an immunomodulatory drug (IMiD, thalidomide or lenalidomide) in patients with relapsed or refractory AL amyloidosis. Crossover to the investigational treatment arm is not permitted during participation in this study.

   NCT ID:

   NCT01659658

   IRB Number:

   12-005223

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   Who can I contact for additional information about this study?

   Rochester: Dispenzieri
                       
   Scottsdale: Reeder
                       
   
   

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4. Phase I, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis Rochester, MN View Summary
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   Phase I, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The purpose of the dose escalation phase of the study is to determine the maximum tolerated dose/Phase 2 recommended dose of NEOD001 when given as a single agent intravenously in approximately 30 subjects with AL amyloidosis. The purpose of the expansion phase of the study is to evaluate the safety, preliminary efficacy and pharmacokinetics of single agent NEOD001 at the maximum tolerated dose/Phase 2 recommended dose in approximately 20 additional evaluable subjects.

   NCT ID:

   NCT01707264

   IRB Number:

   12-007863

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   Who can I contact for additional information about this study?

   Rochester: Ann Birgin, CRA 507-284-8828
                       
   
   
   

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