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Thalidomide-Dexamethasone Incorporated Into Double Autologous Stem-Cell Transplantation for Patients Less Than 65 Years of Age With Newly Diagnosed Multiple Myeloma
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.
Details
| Lead sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 378 |
| Start date | 2002-03 |
| Completion | 2009-01 |
Conditions
- Multiple Myeloma
Interventions
- Thalidomide
- Dexamethasone
- Zoledronic acid
- Cyclophosphamide
- Melphalan
Primary outcomes
- 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).