REVEAL

• Research type

  Research Study

• Full title

  A pilot study of relapsed or refractory patients using Velcade™ (bortezomib) combination chemotherapy in AL amyloidosis (REVEAL)

• IRAS ID

  38844

• Contact name

  Ashutosh Wechalekar

• Sponsor organisation

  University College London

• Eudract number

  2009-014906-33

• ISRCTN Number

  n/a

• Research summary

  The trial aims to assess the efficacy, safety and tolerability of two bortezomib-based combination chemotherapy regimens in patients with AL Amyloidosis who have relapsed (disease has been successfully treated but has returned) or have inadequate response to front line treatment (disease has responded partly but not enough to improve the amyloid related organ function) or are refractory (disease has not responded at all to prior treatment). Background:AL amyloidosis is a multisystem disorder resulting from the accumulation of abnormal protein deposits called amyloid deposits in various organs of the body, causing impairment of organ function. The deposited proteins are formed by light chains secreted by abnormal plasma cells (a type of blood cell). Treatment of AL amyloidosis involves chemotherapy to kill the abnormal plasma cell, thus reducing the abnormal light chains, in the hope of slowing down or halting amyloid deposition, and preserving organ function. Bortezomib, used as a single agent, has been shown to be an effective agent for treating myeloma and amyloidosis and combining it with other drugs appears to increase the rapidity and completeness of response i.e. a quick and long-lasting remission in myeloma. The current study would be the first study of such combinations in relapsed or refractory AL amyloidosis.Specific Aims of Research:The study will compare two bortezomib-dexamethasone-chemotherapy combinations, one with adriamycin (PAD) and one with cyclophosphamide (CVD), in a randomised multicentre parallel phase II design.Outline of research Plan:The patients will be identified and consented at the UK National Amyloidosis Centre and will be treated at regional haematology centres (RHCs). They will be given 3 cycles of chemotherapy and will be assessed for response thereafter. Those who have only a partial response will continue to a maximum of six cycles.The trial results will inform a future phase III trial investigating treatment options in this patient group.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  10/H0715/30

• Date of REC Opinion

  17 Sep 2010

• REC opinion

  Further Information Favourable Opinion