KW-2478 in Combination with Bortezomib in Multiple Myeloma

• Research type

  Research Study

• Full title

  An Open-Label, Dose Escalation, Multicenter Phase 1/2 Study of KW-2478 in Combination with Bortezomib in Subjects with Relapsed and/or Refractory Multiple Myeloma

• IRAS ID

  34471

• Contact name

  Jamie Cavenagh

• Sponsor organisation

  Kyowa Hakko Kirin UK Ltd

• Eudract number

  2009-016223-56

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Multiple myeloma (MM) is a type of cancer that affects cells in the bone marrow that normally produce antibodies to fight infection. The cancerous cells produce high levels of antibodies which can cause symptoms such as bone damage and kidney problems.There are different treatments for MM,including drugs that help to produce high levels of proteins that can destroy cancer cells. One of these types of drugs, called a proteasome inhibitor, is called bortezomib. Despite the use of drugs, such as bortezomib, MM still returns in some patients and some patients can develop a resistance to the treatment. KW-2478 belongs to a new class of drugs called ??Heat Shock Protein 90 inhibitors? or Hsp90 inhibitors. These drugs decrease the proteins that help cancer cells to survive. In a previous study of MM patients given KW-2478, results showed that KW-2478 was safe and may have beneficial effects in MM patients who have experienced drug resistance or where their MM returns.Kyowa Hakko Kirin is sponsoring a study to collect information on KW-2478 when used together with bortezomib which is already given for the treatment of MM. Adults diagnosed with MM who may have failed previous treatments will be given KW-2478 together with bortezomib. This is called an ??open label study? and means both the patients and study doctor know which drug and dose level is being given. This study will be conducted in 2 phases: Phase 1: This phase is to establish the highest dose of KW-2478 and bortezomib that's safe to give to patients. The best doses to be used in the next phase will be decided during this phase. Phase 2: This phase is to investigate how effective the selected dose is at treating MM.This is a multicentre study which will take place across the United Kingdom and the United States of America. It is anticipated that approximately 125 patients will be recruited worldwide, half of which will be in the UK.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  09/H0703/117

• Date of REC Opinion

  9 Feb 2010

• REC opinion

  Further Information Favourable Opinion