This study evaluates a new treatment combination of ixazomib with cyclophosphamide and dexamethasone in relapsed or refractory multiple myeloma. Participants will either receive ixazomib with cyclophosphamide and dexamethasone or cyclophosphamide and dexamethasone alone.
Cyclophosphamide and dexamethasone are very commonly used in the treatment of multiple myeloma and are often given with a third drug (e.g. thalidomide, lenalidomide or bortezomib). The combination of conventional and new drugs has provided benefits in both overall survival and progression free survival, however there are few treatments available for patients who have not responded well (refractory) to their previous treatment or who need further treatment because their myeloma has come back (relapsed). Thus there is a need for new agents for these patients. The development of ixazomib provides the opportunity to increase anti-tumour activity against a wider range of tumour types. Early clinical trials data suggests it has anti-tumour activity in heavily pre-treated multiple myeloma patients with durable responses/disease control and is generally well tolerated. Cyclophosphamide and dexamethasone are both predominantly used in treatment of multiple myeloma and for patients with relapsed or refractory multiple myelomas (RRMM), who have relapsed after bortezomib and lenalidomide. Therefore the evaluation of ixazomib in combination with cyclophosphamide and dexamethasone is the most valuable and practical option for patients. The primary end point of this study is progression-free survival (PFS). Secondary end points include toxicity and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Queen Elizabeth Medical Centre
Birmingham, United Kingdom
Heart of England NHS Foundation Trust
Birmingham, United Kingdom
Progression free survival
Time frame: From randomisation to first documented evidence of disease progression or death, up to 36 months.
Response to treatment
Time frame: From initial trial treatment until at least partial response is achieved, up to 36 months..
Maximum response
Time frame: From initial trial treatment each of the response categories are achieved stringent complete response, complete response, very good partial response, partial response, minimal response or stable disease, up to 36 months.
Time to progression
Time frame: From randomisation to first documented evidence of disease progression, up to 36 months..
Time to maximum response
Time frame: From randomisation until the participant achieves any of the categories stringent complete response, complete response, very good partial response, partial response, minimal response or stable disease, up to 36 months.
Response duration
Time frame: From the first observation of at least partial response until disease progression, up to 36 months.
Overall survival
Time frame: From randomisation to death, up to 36 months.
Evaluate the safety and toxicity as measured by adverse reactions and serious adverse event reporting.
Time frame: From consent until 28 days after the last dose of trial treatment, up to 36 months.
Treatment compliance measured by treatment delays and missed treatment doses.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Royal Bournemouth General Hospital
Bournemouth, United Kingdom
University Hospital Bristol NHS Foundation Trust
Bristol, United Kingdom
North Tees and Hartlepool NHS Foundation Trust
Hartlepool, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Royal Liverpool and Broadgreen University Hospital NHS Trust
Liverpool, United Kingdom
Barts and the London NHS Trust
London, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
Guy's and St Thomas's NHS Foundation Trust
London, United Kingdom
...and 8 more locations
Time frame: From initial treatment received as per protocol until withdrawal from treatment, up to 36 months.
Quality of life measured by the completion of EQ-5D and EORTC QLQ-C30 questionnaires
Time frame: Completed every 3 months from consent until disease progression, up to 36 months.
Cost effectiveness of treatment assessed by health economic evaluations.
Time frame: From consent up to 36 months.