THAL-DEX Incorporated Into Double PBSC Autotransplantation for Untreated Multiple Myeloma (MM)
Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
Summary
The marked activity of thalidomide (thal) and dexamethasone (dex) in relapsed and refractory
multiple myeloma (MM) provided the basis for this phase 2 clinical study aimed at
investigating the efficacy and toxicity of thal-dex incorporated into melphalan-based double
autologous stem cell transplantation (ASCT)for patients less than 65 years old with newly
diagnosed symptomatic MM. Thal-dex was given as primary induction therapy and was then
continued throughout the subsequent treatment phases until the day before the second
autotransplantation. Primary study endpoints,as evaluated on an intention to treat basis, are
response rates to the different treatment phases (induction, first and second ASCT), best
response whenever achieved, duration of response (DOR), time to progression (TTP),
progression free survival (PFS)and toxicity profile of thal-dex. Secondary endpoints, as
evaluated on an intention to treat basis, are overall survival (OS) and clinical outcomes
(DOR, TTP, PFS and OS)according to prognostic factors, including cytogenetic abnormalities
and imaging features, as detected by 18F-FDG PET/CT.
Phase:
Phase 2
Details
Lead Sponsor:
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi IRCCS Azienda Ospedaliero-Universitaria di Bologna