Viewing Study NCT02858999



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Last Modification Date: 2024-10-26 @ 12:07 PM
Study NCT ID: NCT02858999
Status: COMPLETED
Last Update Posted: 2016-12-01
First Post: 2016-08-04

Brief Title: Treatment of Primary Plasma Cell Leukaemia in Subjects Under the Age of 70
Sponsor: Centre Hospitalier Universitaire Amiens
Organization: Centre Hospitalier Universitaire Amiens

Study Overview

Official Title: Treatment of Primary Plasma Cell Leukaemia in Subjects Under the Age of 70 Phase II Multicentre Study
Status: COMPLETED
Status Verified Date: 2016-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: LPP
Brief Summary: Plasma cell leukaemia is a rare variety of multiple myeloma with a poor prognosis Plasma cell leukaemia is defined as at least 2000 circulating plasma cells per µL for a blood leukocyte count higher than 10000µL or 20 of plasma cells for a leukocyte count less than 10000µL Plasma cell leukaemia can be either primary when it constitutes the first manifestation of the disease or secondary in the setting of relapsedrefractory multiple myeloma Primary plasma cell leukaemia PPL is a rare disease representing only 1 to 2 of all cases of multiple myelomas at diagnosis As the annual incidence of multiple myeloma in France is about 4000 new cases an estimated 40 to 80 new cases of PPL would be observed each year

Few data are currently available in the literature concerning the pathophysiology and therapeutic management of PPL and are derived from retrospective series based small numbers of patients The prognosis of PPL in response to conventional chemotherapy remains poor with a median survival of 7 to 14 months However longer survivals have been obtained with intensive therapy and haematopoietic stem cell transplantation allogeneic or autologous HSCT

The investigators propose to perform a prospective study of the management of patients with PPL under the age of 70 years in combination with a laboratory study 12 weeks of induction chemotherapy by liposomal Bortezomib-Dexamethasone-Doxorubicin PAD alternating with Bortezomib-Dexamethasone-Cyclophosphamide VCD for a total of 4 cycles Peripheral blood stem cell collection after mobilization by G-CSF will be performed after high-dose Cyclophosphamide chemotherapy Autologous HSCT conditioned by high-dose Melphalan will be performed during the following month for all responding patients During the 3 months after this first autologous HSCT allogeneic HSCT with attenuated conditioning will be proposed in patients under the age of 66 years in complete remission with a suitable donor and another systematic autologous HSCT will be proposed in all other patients For all patients not treated by allogeneic HSCT consolidationmaintenance therapy will be performed 3 months after the second autologous HSCT 4 quarterly consolidations with Bortezomib-Lenalidomide-Dexamethasone VRD with maintenance by 2 months of Lenalidomide between these cycles for a total duration of one year

The laboratory assessment will consist of blood and bone marrow samples systematically obtained at diagnosis for plasma cell phenotyping by cytometry cytogenetics FISH study of the gene expression profile and SNParray A DNA bank and plasma bank will be constituted The investigators also propose to study residual disease by cytometry after the first autologous HSCT before and at the end of the consolidationmaintenance phase as it increasingly appears to have a major impact on survival in multiple myeloma
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None