NCT04965155

A Trial for Relapsed Multiple Myeloma Patients (Isatuximab-dexamethasone)

Isatuximab and Autologous Hematopoietic Stem Cell Transplantation for Relapsed Multiple Myeloma Patients (Isabel Study)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: EMN Trial Office S.r.l. Impresa Sociale · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Isatuximab-dexamethasone	Isatuximab 10 mg/kg IV: 1,8,15 and 22 at cycle 1; days 1 and 15 at cycles 2-3 Dexamethasone 40 mg OS: 1,8,15 and 22 at cycle 1; days 1 and 15 at cycles 2-3

Timeline

• Start date: 2021-03-21
• Primary completion: 2023-11-28
• Completion: 2027-03-31
• First posted: 2021-07-16
• Last updated: 2025-02-25

Locations

14 sites across 1 country: Italy