Multiple Myeloma Clinical Trial
Official title:
Phase II Study of Carfilzomib-cyclophosphamide-dexamethasone and High-dose Melphalan (HDT) Followed by Randomization Between Observation or Maintenance With Carfilzomib and Dexamethasone in Patients With Relapsed Multiple Myeloma After HDT
This study evaluates induction therapy with carfilzomib-cyclophosphamide-dexamethasone before salvage high-dose melphalan with autologous stem cell support (HDT) in multiple myeloma patients with relapse after HDT done at diagnosis. In addition, the study evaluates the effect of maintenance therapy after salvage HDT in multiple myeloma. After salvage HDT half of the patients receive maintenance therapy with carfilzomib/dexamethasone while the other half are observed without maintenance therapy.
The survival in younger myeloma patients improved in the nineties with the introduction of
high-dose melphalan with autologous stem cell support (HDT) and despite the emergence of
novel therapies HDT remains a keystone in myeloma treatment. However, all patients will
eventually experience relapse after HDT performed at diagnosis. Eligible patients with late
relapse are considered for salvage HDT. The duration of response after salvage HDT is in most
studies reported to be approximately half the length of the response after initial HDT. The
choice of induction treatment before HDT might affect the outcome after the induction therapy
as well as the outcome after the HDT. In other settings the novel proteasome inhibitor
Carfilzomib has showed superiority to the first-in-class proteasome inhibitor bortezomib. In
addition, carfilzomib has a favourable profile of side effects. Thus, the aim of this phase 2
study is to evaluate induction therapy with carfilzomib-cyclophosphamide-dexamethasone before
salvage HDT. The primary end-point in this part of the study is comparison of time to
progression after the initial HDT and time to progression after salvage HDT when four series
of carfilzomib-cyclophosphamide-dexamethasone are used as induction therapy. In the study
Carfilzomib is also included in the conditioning regimen with administration of Iv
carfilzomib 27 mg/sqm on day -2 and -1. The standard conditioning regime consists of Iv
melphalan 200 mg/sqm on day -2 and reinfusion of at least 2.0 x 10m CD34+ stem cells/kg body
weight on day 0.
The purpose of maintenance therapy in multiple myeloma is to prolong the time to progression
of disease. There are limited data on the impact of maintenance therapy after salvage HDT.
Another important aim of the study is therefore to evaluate the effect of
carfilzomib/dexamethasone given every other week compared to observation without maintenance
therapy. This part of the study starts two months after HDT. The randomization is stratified
according to relapse 1 - 2 years or > 2 years after HDT, ISS stage and standard versus
high-risk cytogenetics. The primary end-point of this part of the study is comparison of time
to progression in carfilzomib-dexamethasone maintenance arm and in the observational arm.
Patients will continue on maintenance therapy/observation until progression, end of study or
fulfil standard criteria for discontinuation of treatment according to the protocol.
The study will include 200 patients with relapse of multiple myeloma more than one year after
initial HDT. It is a prerequisite that the patients have at least 2.0 x 10m CD34+ stem
cells/kg body weight saved in the freezer. The study is conducted by the Nordic Myeloma Study
Group (NMSG) at clinics in Denmark, Sweden, Norway, Finland and Lithuania. The first patient
was included in January 2015 and enrolment is expected to continue until December 2017. The
study ends when the last included patient has been followed for 9 months after randomization.
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