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A multicentre single arm study of carfilzomib-thalidomide-dexamethasone (CarTD) for newly diagnosed transplant-eligible multiple myeloma (MM) patients refractory to initial bortezomib-based induction therapy
Who is it for? You may be eligible to join this study if you are aged over 18 years, have been diagnosed with symptomatic NDMM as per International Myeloma Working Group (IMWG) criteria, are eligible for high-dose melphalan conditioned autologous stem cell transplant (ASCT) and failed to achieve a minimum response or partial response on 2 or 4 cycles of prior bortezomib-based induction therapy respectively.
Enrolled participants will first undergo 4 x 4-week cycles of salvage CarTD therapy, followed by an additional 2 cycles if they do not achieve a stringent complete response.
Participants will then receive melphalan-conditioned ASCT, followed by 2 cycles of consolidation CarTD therapy. Patients will be monitored for myeloma response and safety and tolerability of CarTD therapy using blood samples, and the assessment of toxicities (adverse event review) as well as for disease progression and survival information for up to 3 years following the completion of treatment.
It is hoped that the findings of this trial will provide an evaluation of the efficacy and safety of CarTD salvage and consolidation therapy in multiple myeloma patients who do not respond to the standard care bortezomib-based therapy.