Cardamon trial
Research type
Research Study
Full title
Carfilzomib/Cyclophosphamide/Dexamethasone with maintenance carfilzomib in untreated transplant-eligible patients with symptomatic MM to evaluate the benefit of upfront ASCT
IRAS ID
148600
Contact name
Kwee Yong
Contact email
Sponsor organisation
University College London
Eudract number
2014-000506-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
14 years, 3 months, 19 days
Research summary
Multiple myeloma (MM) is a plasma cell cancer with an incidence of approximately 5-6 per 100,000. The disease is sensitive to chemotherapy treatment in most newly diagnosed patients, and responds best to combination regimens incorporating chemotherapy and steroids. Front line treatment for newly diagnosed patients who are young and fit enough includes induction therapy that is consolidated with high dose melphalan and autologous stem cell transplantation (ASCT).
The Cardamon study is a phase II study with two stages. The first stage will confirm the efficacy of the combination regimen using carfilzomib, cyclophosphamide and dexamethasone (CarCyDex). Carfilzomib is a new treatment for multiple myeloma which is not yet licensed in the UK (it is licensed for use in the US in patients with refractory myeloma). Studies have shown it to be effective as part of a combined induction therapy in MM. Cyclophosphamide and dexamethasone are currently used as part of combination treatments in MM patients.
In the second stage, patients achieving at least a partial response (PR) to the induction regimen will be randomised to either ASCT or 4 further cycles of CarCyDex. This second stage will estimate the benefit of upfront ASCT, for those patients who respond (≥PR) to CarCyDex. Patients randomised to receive 4 further cycles of CarCyDex (no ASCT arm) will be compared with patients randomised to receive ASCT.
All randomised patients will then receive maintenance with single agent carfilzomib as other studies have shown the potential for extending disease control by using low dose single agent maintenance therapy, and this is an important question in multiple myeloma therapy today.
Radiological evaluation of disease response by PET-CT in a sub-group of up to 120 patients, to correlate with other response modalities and to explore prognostic value with respect to PFS and OS in both treatment arms.
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/0023
Date of REC Opinion
23 Feb 2015
REC opinion
Further Information Favourable Opinion