Multiple Myeloma Clinical Trial
Official title:
European Myeloma Network Sequential Phase I / Phase II Trial on RIC Allogeneic Transplantation: an Optimized Program for High Risk Relapsed Patients
The aim of the current study is to improve the outcome of patients with hematologic
malignancies (in a phase I trial) and more specifically multiple myeloma (in a phase II
trial) by 2 interventions: reduce the risk of graft-versus-host disease (GVHD) and improve
the efficacy of the procedure decreasing the risk of relapses after transplant.
Currently, the standard approach used in most centers to prevent graft-versus-host disease
after allogeneic transplantation is based on the combination of a calcineurin inhibitor
(cyclosporine or tacrolimus) plus a short course of methotrexate. Unfortunately, this
strategy is far from ideal, since the risk of acute GVHD is in the range of 30-40% among
patients receiving a matched related donor transplantation and even higher among patients
receiving transplantation from an unrelated donor while the incidence of chronic GVHD is
60-70% among patients receiving peripheral blood progenitor cells from either a related or
unrelated donor.
As far as the patients with multiple myeloma (MM) is concerned, although the development of
new drugs has markedly changed the outcome and management of these patients, allogeneic
transplantation so far appears to be the only curative option, especially among those
patients relapsing after first line treatment. Nevertheless, still new strategies within the
allogeneic transplant setting are needed to improve its results.
Relapses may occur either extramedullary (very common in this setting) or systemic. In order
to reduce the risk of systemic relapses the investigators will use maintenance therapy with
Lenalidomide (Len) which, together with bortezomib (Bz) should contribute to eradicate
minimal residual disease (MRD). In case the patient do not obtain complete remission or near
complete remission after transplant, in addition to the maintenance therapy, the
investigators will use four intensification cycles with VRD (Bz-Len-Dexamethasone).
In summary, the goal is to optimize the efficacy of allogeneic transplantation by two
interventions: one focused on reducing the risk of relapse and the other on reducing the
incidence of GVHD.
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