We presented the CHAMPION-2 data which is a phase Ib dose escalation trial of carfilzomib with fixed dose cyclophosphamide and dexamethasone. We looked to treat newly diagnosed multiple myeloma patients who were not planned to undergo transplant, at least during the clinical trial, substituting carfilzomib for bortezomib in what might be called the CyBorD non-IMiD based combination triplet therapy.
What were your findings?
We planned three dose escalated three by three to expand to a larger cohort using carfilzomib, first at 36mg/m2 then 45 mg/m2. When we found no dose limiting toxicities we expanded it to 56mg/m2.
How many patients were involved?
We treated a total of 21 patients: 3 at the 36mg, 3 at the 45mg and 15 at the 56mg/m2 dose.
What were the results?
We found excellent activity – almost 90% of patients responded and we had VGPRs or better at just over 50%.
Did the results vary between groups?
We had a total of 3 at the 36 and 3 at the 45 and so we saw responses at all the dose levels.
What are the implications?
We believe that this is an excellent non-IMiD based alternative to triplet therapy in the newly diagnosed patient with multiple myeloma. It appears to be safe and effective.