NCT04965155: ISABEL

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

Active, enrolled Phase 2 Last updated 25 February 2025

What this trial tests

Phase 2 trial testing Isatuximab-dexamethasone in Relapsed Multiple Myeloma in 50 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 March 2021

Primary endpoint
28 November 2023

31 March 2027

Quick facts

Lead sponsor	EMN Trial Office S.r.l. Impresa Sociale
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	21 March 2021
Primary completion	28 November 2023
Estimated completion	31 March 2027
Sites	14 locations across Italy

Drugs / interventions tested

• Isatuximab-dexamethasone — full drug profile →

Conditions studied

• Relapsed Multiple Myeloma — all drugs for Relapsed Multiple Myeloma →

Sponsor

EMN Trial Office S.r.l. Impresa Sociale — full company profile →

Who can join

Adults 18 to 70, any sex, with Relapsed Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immune checkpoint modulators in cancer immunotherapy: recent advances and emerging concepts.
   Wang Y, Zhang H, Liu C, Wang Z, et al · · 2022 · cited 179× · PMID 35978433 · DOI 10.1186/s13045-022-01325-0
2. Stem cell therapies in the clinic.
   Acharya S, Shaha S, Bibbey MG, Mukherji M, et al · · 2025 · cited 3× · PMID 40385529 · DOI 10.1002/btm2.70000