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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thalidomide | Drug |
| ||
| Dexamethasone | Drug |
| ||
| Zoledronic acid | Drug |
| ||
| Cyclophosphamide | Drug | Cyclophosphamide 7 g/sqm + G-CSF 5 mcg/Kg from the day +6 for stem cell mobilisation |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate (at least PR, VGPR, nCR and CR) to thal-dex induction | 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). | 120 days after the start day of tal-dex induction therapy |
| duration of response (partial response, PR, very good partial response, VGPR, complete response, CR) | Duration of response is calculated from the first achievement of the response (at least PR, at least VGPR, at least CR) to relapse/progression | Average time period between the day of first achievement of response and the day of first relapse or progression |
| time to progression (TTP) | TTP is calculated from the start date of induction therapy to the date of relapse/progression | Average time period between the start day of induction therapy and the day of relapse or progression |
| progression free survival (PFS) | PFS is calculated from the start date of induction therapy to the date of relapse/progression or death for any cause, whichever occurs first | Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly |
| toxicity of thal-dex (induction and subsequent treatment phases) | 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. | Within 30 days after the last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS is measured from the start date of induction therapy until death from any cause | Average time period between the start day of induction therapy and the day of death, due to any cause |
| OS by cytogenetic abnormalities |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michele Cavo, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21900189 | Derived | Zamagni E, Patriarca F, Nanni C, Zannetti B, Englaro E, Pezzi A, Tacchetti P, Buttignol S, Perrone G, Brioli A, Pantani L, Terragna C, Carobolante F, Baccarani M, Fanin R, Fanti S, Cavo M. Prognostic relevance of 18-F FDG PET/CT in newly diagnosed multiple myeloma patients treated with up-front autologous transplantation. Blood. 2011 Dec 1;118(23):5989-95. doi: 10.1182/blood-2011-06-361386. Epub 2011 Sep 6. |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D013792 | Thalidomide |
| D003907 | Dexamethasone |
| D000077211 | Zoledronic Acid |
| D003520 | Cyclophosphamide |
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| Melphalan | Drug | Melphalan 200 mg/sqm on day -1 for first and second ASCT |
| Response rate (at least PR, VGPR, nCR and CR) to 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). | 90 days after first ASCT |
| Response rate (at least PR, VGPR, nCR and CR) to 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). | 90 days after second ASCT |
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)
| Average time period between the start day of induction therapy and the day of death, due to any cause |
| OS by 18F-FDG PET/CT imaging | OS is calculated as defined above in patients with different PET/CT patterns (normal, focal, diffuse, presence or absence of extramedullary disease) | Average time period between the start day of induction therapy and the day of death, due to any cause |
| TTP by cytogenetic abnormalities | 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) | Average time period between the start day of induction therapy and the day of relapse or progression |
| PFS by cytogenetic abnormalities | 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) | Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly |
| TTP by 18F-FDG PET/CT imaging | TTP is calculated as defined above in patients with different PET/CT patterns (normal, focal, diffuse, presence or absence of extramedullary disease) | Average time period between the start day of induction therapy and the day of relapse or progression |
| PFS by 18F-FDG PET/CT imaging | PFS is calculated as defined above in patients with different PET/CT patterns (normal, focal, diffuse, presence or absence of extramedullary disease) | Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |