THAL-DEX Incorporated Into Double PBSC Autotransplantation for Untreated Multiple Myeloma (MM)
- Conditions
- Multiple Myeloma
- Registration Number
- NCT01341262
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 378
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response rate (at least PR, VGPR, nCR and CR) to thal-dex induction 120 days after the start day of tal-dex induction therapy Responses are reported by study investigators and centrally reassessed by study coordinator(s). Criteria are those initially proposed by the European Group for Blood and Marrow Transplantation (EBMT), with the addition of nCR (100% M-protein reduction by electrophoresis, but immunofixation-positive)and VGPR (at least 90% reduction of M component).
duration of response (partial response, PR, very good partial response, VGPR, complete response, CR) Average time period between the day of first achievement of response and the day of first relapse or progression Duration of response is calculated from the first achievement of the response (at least PR, at least VGPR, at least CR) to relapse/progression
time to progression (TTP) Average time period between the start day of induction therapy and the day of relapse or progression TTP is calculated from the start date of induction therapy to the date of relapse/progression
progression free survival (PFS) Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly PFS is calculated from the start date of induction therapy to the date of relapse/progression or death for any cause, whichever occurs first
toxicity of thal-dex (induction and subsequent treatment phases) Within 30 days after the last dose of study drug Adverse events are assessed monthly and graded according to the National Cancer Institute Common Toxicity Criteria, version 2. Safety is monitored until 30 days after the last dose of study drug.
Response rate (at least PR, VGPR, nCR and CR) to first ASCT 90 days after first ASCT Responses are reported by study investigators and centrally reassessed by study coordinator(s). Criteria are those initially proposed by the European Group for Blood and Marrow Transplantation (EBMT), with the addition of nCR (100% M-protein reduction by electrophoresis, but immunofixation-positive)and VGPR (at least 90% reduction of M component).
Response rate (at least PR, VGPR, nCR and CR) to second ASCT 90 days after second ASCT Responses are reported by study investigators and centrally reassessed by study coordinator(s). Criteria are those initially proposed by the European Group for Blood and Marrow Transplantation (EBMT), with the addition of nCR (100% M-protein reduction by electrophoresis, but immunofixation-positive)and VGPR (at least 90% reduction of M component).
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Average time period between the start day of induction therapy and the day of death, due to any cause OS is measured from the start date of induction therapy until death from any cause
OS by cytogenetic abnormalities Average time period between the start day of induction therapy and the day of death, due to any cause OS is calculated as defined above in patients with or without high risk cytogenetic abnormalities (translocation t(4;14), deletion chromosome 17p, deletion chromosome 13q)
OS by 18F-FDG PET/CT imaging Average time period between the start day of induction therapy and the day of death, due to any cause OS is calculated as defined above in patients with different PET/CT patterns (normal, focal, diffuse, presence or absence of extramedullary disease)
TTP by cytogenetic abnormalities Average time period between the start day of induction therapy and the day of relapse or progression TTP is calculated as defined above in patients with or without high risk cytogenetic abnormalities (translocation t(4;14), deletion chromosome 17p, deletion chromosome 13q)
PFS by cytogenetic abnormalities Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly PFS is calculated as defined above in patients with or without high risk cytogenetic abnormalities (translocation t(4;14), deletion chromosome 17p, deletion chromosome 13q)
TTP by 18F-FDG PET/CT imaging Average time period between the start day of induction therapy and the day of relapse or progression TTP is calculated as defined above in patients with different PET/CT patterns (normal, focal, diffuse, presence or absence of extramedullary disease)
PFS by 18F-FDG PET/CT imaging Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly PFS is calculated as defined above in patients with different PET/CT patterns (normal, focal, diffuse, presence or absence of extramedullary disease)