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Microsoft word - myeloma xi trial summary v1.doc
This is a pragmatic, randomised, phase III, multi−centre, parallel group design, openlabelled trial comparing thalidomide, lenalidomide and bortezomib combinations andmaintenance lenalidomide in newly diagnosed patients with symptomatic myeloma. Anintensive treatment pathway will be followed by younger/fitter patients where intensiveHDT with stem cell support is considered appropriate, whilst older/less fit patients willproceed through the non−intensive pathway. Both pathways comprise induction,consolidation and maintenance components.
Aims and Objectives
The trial aims to answer three main questions: at induction, consolidation andmaintenance:-
1. Is cyclophosphamide-lenalidomide-dexamethasone (RCD) given to maximum
response, a better induction regimen than the current UK gold standard ofcyclophosphamide-thalidomide-dexamethasone (CTD)?
2. For patients achieving a sub optimal response to induction across both treatment
dexamethasone (VCD) improve responses and does this translate into improvedPFS and OS?
3. Can lenalidomide at maintenance improve PFS and OS when compared to the use
Patients newly diagnosed as having symptomatic multiple myeloma or non-secretorymultiple myeloma will be eligible for inclusion. Patients will be defined as younger/fitteror older/less fit, based on their age and general fitness. Strict age restrictions havebeen deliberately avoided to prevent fit older patients being denied intensive therapy.
The recruitment target requires that approximately 492 patients are recruited per yearover a 4 year period.
Patients will be initially randomised to receive either CTD (cyclophosphamide,thalidomide and dexamethasone) or RCD (cyclophosphamide, lenalidomide anddexamethasone).
All patients showing a complete response (CR) or very good partial response(VGPR) to RCD/CTD will proceed to peripheral blood stem cell harvest and standardhigh−dose melphalan (HDM) with supporting autologous peripheral blood stem celltransplant (ASCT).
Patients showing a partial response (PR) or minimal response (MR) to RCD/CTD willbe randomised to receive consolidation bortezomib plus cyclophosphamide anddexamethasone (VCD), or proceed straight to peripheral blood stem cell harvest andstandard HDM with supporting ASCT. Once randomised patients have receivedVCD, they will proceed with harvest, HDM and ASCT.
Patients showing progressive disease (PD) or no change (NC) during inductionchemotherapy (RCD or CTD) will all receive consolidation VCD (ie will not undergothe VCD vs nothing randomisation), then proceed to peripheral blood stem cellharvest and standard HDM with supporting ASCT.
Following HDM/ASCT, all patients who are disease progression−free (except thosewho demonstrated PD or NC during RCD) will undergo maintenance randomisationto either lenalidomide maintenance or no maintenance treatment. Maintenance willcontinue until disease progression
Patients will be randomised to RCDa (RCD with a reduced dose of dexamethasone)or CTDa (CTD with a reduced dose of dexamethasone and lower starting dose ofthalidomide).
All patients showing CR or VGPR will proceed to maintenance randomisation(lenalidomide or no maintenance).
Patients showing PR or MR to RCDa/CTDa will be randomised to receiveconsolidation VCD, or proceed to maintenance randomisation. Once randomisedpatients have received VCD, they will proceed with maintenance randomisation.
Patients showing progressive disease (PD) or NC during induction chemotherapy(RCDa or CTDa) will all receive consolidation VCD (ie will not undergo the VCD vsnothing randomisation).
Following RCD/CTD/VCD, all patients who are disease progression−free (exceptthose who demonstrated PD or NC during RCDa) will undergo maintenancerandomisation to either lenalidomide maintenance or no maintenance treatment.
Maintenance will continue until disease progression.
The primary end points are overall survival and progression free survival.
The secondary endpoints are response, conversion rate to CR/VGPR for patients whoundergo VCD, toxicity and biological endpoints
The trial is currently in set up and it is anticipated that it will be open to recruitment inlate autumn 2009.
Lenalidomide will be supplied by Celgene at the same cost as thalidomide
Intensive pathway outline
Non-intensive pathway outline
* In the absence of disease progression patients should receive a minimum of 4 cycles of induction chemotherapy in the intensive pathway or 6 cycles in thenon-intensive pathway (as long as they are responding) and should continue to maximum response or intolerance. Patients showing NC after 4 cycles orprogressive disease at any time during their induction chemotherapy should proceed to VCD
**Patients entered into the RCD(a) arm and assessed as NC or PD at the end of RCD(a) induction are not eligible for lenalidomide maintenancerandomisation
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Antonio E. Puente Personal Data University: Born: February 14, 1952; La Habana, Cuba Family: Married, three children Education Institution Field of Concentration Florida Junior College Jacksonville, Florida University of Florida Appointments and Positions Position/Rank Institution Dates Teaching Assistant Northeast Florida State Hospital 1979