EMN12/HO129
Research type
Research Study
Full title
Carfilzomib and lenalidomide-based treatment for younger and elderly newly diagnosed primary plasma cell leukemia patients
IRAS ID
239072
Contact name
Reuben Benjamin
Contact email
Sponsor organisation
HOVON
Eudract number
2013-005157-75
Duration of Study in the UK
6 years, 8 months, 25 days
Research summary
Plasma cell leukaemia (PCL) is a rare yet aggressive form of multiple myeloma (a type of bone marrow cancer) characterised by high levels of plasma cells (a type of white blood cell) circulating in the blood. The disease presents as primary plasma cell leukaemia (pPCL) in patients without prior history of a plasma cell dyscrasia (abnormality). Although presenting symptoms can include those seen in multiple myeloma, pPCL is a far more aggressive disease.
The prognosis of pPCL is very poor, with a median overall survival of only 7 months with standard chemotherapy. The introduction of autologous stem cell transplant (patient's own stem cells collected then later returned) and new drugs such as bortezomib have recently improved the outcome of patients with pPCL, but the outcome remains inferior when compared to multiple myeloma. Lenalidomide and bortezomib combined with dexamethasone are now recognised as the most effective drugs to produce an initial response where the cancer level becomes very low, or undetectable, in patients with multiple myeloma. Bortezomib unfortunately causes peripheral neuropathy (nerve damage). Replacing bortezomib with a drug with similar properties and outcomes, (carfilzomib) could allow effective treatment without nerve damage. New treatment approaches combining various treatment methods are required to improve outcome.
The main aim of this study is to evaluate progression-free survival in adult pPCL patients by incorporating new drugs, carfilzomib and lenalidomide, in to their treatment.
Younger patients will receive their pPCL treatment with carfilzomib, lenalidomide and dexamethasone incorporated in to Induction, Consolidation and Maintenance therapy. They will also receive autologous stem cell transplantation, and potentially an allogeneic (stem cells are provided by a donor) transplant.
Older patients will receive their pPCL treatment of Induction, Consolidation and Maintenance with carfilzomib, lenalidomide and dexamethasone incorporated.
This is a multicentre trial with 61 pPCL patients being recruited across Europe.REC name
London - London Bridge Research Ethics Committee
REC reference
20/LO/0180
Date of REC Opinion
15 May 2020
REC opinion
Further Information Favourable Opinion