This study is determining whether the addition of cyclophosphamide to pomalidomide and dexamethasone improves progression free survival in patients with relapsed refractory myeloma (RRMM) compare to pomalidomide and dexamethasone alone. Patients will be randomised on a 1:1 basis to receive CPD or Pd. Treatment will be continued until disease progression or unacceptable toxicity.
Multiple myeloma is the second most common hematologic malignancy in the European Union (EU), responsible for an estimated 21,000 deaths in the EU in 2008. For patients that relapse or are refractory to current standard treatment (combination of bortezomib/lenalidomide, dexamethasone and an alkylating agent) there are few options available and therefore the prognosis within this group is often poor with response to treatment decreasing with successive relapses until resistant disease develops. . Current standard treatment at first relapse in the UK is the use of bortezomib in combination with dexamethasone and cyclophosphamide. Another common treatment is lenalidomide given with dexamethasone and cyclophosphamide. The addition of cyclophosphamide has demonstrated to improve treatment outcomes whilst being tolerated well. A recent clinical study has shown the addition of cyclophosphamide to the combination of pomalidomide and dexamethasone has shown to be safe and tolerable and beneficial in terms of treatment outcomes. The primary aim of this study is to investigate whether the addition of cyclophosphamide to pomalidomide and dexamethasone leads to an improved progression free survival. A secondary aim is to identify markers from clinical material that will predict response to pomalidomide in a group of relapsed and refractory multiple myeloma (RRMM) patients to provide important information for use in discussions with NICE on how best to improve the value and use of pomalidomide in the UK in the RRMM setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Belfast Health & Social Care Trust
Belfast, United Kingdom
Progression free survival
To determine whether the addition of cyclophosphamide to pomalidomide and dexamethasone (CPD) improves progression-free survival in patients with relapsed refractory myeloma (RRMM) in the UK, compared to pomalidomide and dexamethasone (Pd) alone
Time frame: From randomisation up to 72 months
Maximum response overall
To determine the maximum response achieved from treatment
Time frame: From the start of treatment up to 72 months
Response to treatment
Determine the response to treatment
Time frame: From the start of treatment up to 72 months
Clinical benefit rate overall
Determine any clinical benefit that is derived from treatment
Time frame: From the start of treatment up to 72 months
Time to maximum response
Determine the time to maximum response to treatment
Time frame: From the start of treatment up to 72 months
Duration of response
Determine the duration that the response to treatment lasts for
Time frame: From the start of treatment up to 72 months
Overall survival
Determine overall survival for all patients that receive treatment
Time frame: Date of randomisation to death, up to 72 months
Treatment compliance
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
Queens Hospital
Burton-on-Trent, United Kingdom
University Hospital of Wales NHS Trust
Cardiff, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Beatson Oncology Centre
Glasgow, United Kingdom
St James's Hopsital
Leeds, United Kingdom
University Hospital of Leicester NHS Trust
Leicester, United Kingdom
...and 11 more locations
Measured by treatment delays and missed treatment doses
Time frame: From the start of treatment up to end of treatment
Safety and Toxicity
Measured by adverse reactions and serious adverse event reporting
Time frame: Time of registration to 28 days post treatment discontinuation