Multiple Myeloma Clinical Trial
Official title:
A Randomised Phase II Trial of Cyclophosphamide and Dexamethasone in Combination With Ixazomib in Relapsed or Refractory Multiple Myeloma (RRMM) Patients Who Have Relapsed After Treatment With Thalidomide, Lenalidomide and Bortezomib.
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.
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