MUK five

• Research type

  Research Study

• Full title

  A phase II randomised trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) vs cyclophosphamide, velcade and dexamethasone (CVD) for first relapse or primary refractory multiple myeloma.

• IRAS ID

  97486

• Contact name

  Kwee Yong

• Sponsor organisation

  University of Leeds

• Eudract number

  2012-001320-36

• Research summary

  Current standard treatment for multiple myeloma at first relapse in the UK is the use of the proteasome inhibitor bortezomib. This is commonly administered with dexamethasone. Increasingly, a third agent is added, either an alkylating agent such a cyclophosphamide (CVD) or an anthracycline, doxorubicin (PAD). The combination of CVD is an effective regimen at relapse, producing response rates of up to 70%. Up to 8 cycles are administered, although many patients have their treatment withdrawn before completing 8 cycles because of neuro-toxicity associcated with IV delivery of bortezomib. The development of carfilzomib, an irreversible proteasome inhibitor, offers the opportunity to further explore the anti-tumour efficacy of proteasome inhibition, particularly as some patients have disease that does not respond to bortezomib, or develop resistance after initial response. Carfilzomib has good activity as single agent in the relapsed setting, and it is expected that efficacy will be improved when used in combination with dexamethasone and a third agent. Early experience with the combination with lenalidomide and dexamethasone indicates that this is well tolerated, however, this combination is unlikely to be approved (by NICE) on health economic grounds. The most practical and effective use of carfilzomib in the setting of first relapse or primary refractory multiple myeloma would be in combination with cyclophosphamide and dexamethasone (CCD). This trial is therefore designed to compare the activity of carfilzomib in combination with cyclophosphamide and low dose dexamethasone (CCD) to that of the control treatment of bortezomib, cyclophosphamide and dexamethasone (CVD) in patients with multiple myeloma at first relapse, or refractory to no more than 1 line of treatment.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  12/LO/1078

• Date of REC Opinion

  28 Aug 2012

• REC opinion

  Further Information Favourable Opinion