A Trial for Relapsed Multiple Myeloma Patients (Isatuximab-dexamethasone)
Status:
Not yet recruiting
Trial end date:
2027-05-31
Target enrollment:
Participant gender:
Summary
This is an open label phase II study designed to assess the efficacy and safety of the
combination isatuximab-dexamethasone pre and post transplant in relapsed MM patients. Before
enrolment, patients have already received a reinduction therapy, as per local protocols, in
order to achieve an optimal cytoreduction. Since carfilzomib-based regimens (eg.
carfilzomib-lenalidomide-dexamethasone or carfilzomib-dexamethasone) are the current standard
in Italy, for uniformity the use of one of these combinations is recommended. However, any
cytoreductive treatment, excluding anti-CD38 antibodies containing regimens, as per local
practice, is acceptable. During this period, if necessary, it will be possible to mobilize
and collect peripheral blood stem cells. After the pre-enrollment cytoreduction period
(reinduction therapy), patients have achieved at least a PR according to IMWG Response
criteria.
After study enrolment, patients will receive 3 courses of isatuximab in combination with
dexamethasone; after cycle 3 patients will receive ASCT, that will be conditioned with
melphalan and will be followed by reinfusion of cryopreserved autologous stem cells. At 2
months after ASCT, patients will start maintenance, consisting in the administration of
isatuximab in combination with dexamethasone for 12 cycles. Starting from cycle 13 onwards,
only isatuximab will be administered until progression or intolerance.