Prospective, single center, randomized, open label, parallel group, 2-arm study assessing the clinical benefit in term of enhancement of overall response rate of Isatuximab in combination with CellProtect as compared to Isatuximab for the treatment of patients with newly diagnosed multiple myeloma who are eligible for stem cell transplantation (SCT) as maintenance after SCT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
In vitro expanded and activated autologous NK cells
Naked immunoglobulin (Ig) G1 monoclonal antibody (mAb) that selectively binds to the human cell surface antigen molecule classified as cluster of differentiation (CD) 38
Karolinska University Hospital, Huddinge
Stockholm, Sweden
RECRUITINGOverall response rate as the occurrence of very good partial response or better after maintenance start
Evaluate in both arms the occurance after maintenance start of: Very good partial response (VGPR) or better rate, as defined by the International Myeloma Working Group (IMWG) criteria.
Time frame: From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 96 months
Change in minimal residual disease (MRD) negativity rate
Assessment of changes in MRD negativity rate in patients with complete and very good partial response as well as conversion of MRD positivity to MRD negativity.
Time frame: Before start of maintenance, after first Isatuximab cycle, before start of 4th Isatuximab cycle and at 12 and 24 months after start of maintenance
adverse events
Assessment of treatment-emergent adverse events/serious adverse events (TEAEs/SAEs) (including IARs), laboratory parameters, vital signs, weight, ECOG PS, and findings from physical examination. TEAEs are defined as AEs that develop, worsen (according to the Investigator opinion), or become serious during the treatment period.
Time frame: From first dose of study treatment up to 30 days after the last dose of study treatment or initiation of further anti-myeloma therapy, whichever occurs first, assessed up to 96 months
Time to progression
The time from randomization to the date of first documentation of PD (as determined by the IRC using the IMWG criteria
Time frame: From date of first treatment until date of first documented progression, date of further anti-myeloma therapy or date of death from any cause, whichever came first, assessed up to 96 months
Progression-free survival on/after study medication
The time from the date of the start of maintenance treatment to the date of documented progressive disease (PD) or death, whichever comes first.
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Time frame: From date of first treatment until date of first documented progression, date of further anti-myeloma therapy or date of death from any cause, whichever came first, assessed up to 96 months
Duration of response
The time from the date of the first IRC determined response to the date of first IRC PD or death, whichever occurs first. Duration of response will determined only for patients who have achieved CR, VGPR, or PR.
Time frame: From date of first treatment until date of first documented progression, date of further anti-myeloma therapy or date of death from any cause, whichever came first, assessed up to 96 months
Overall survival
Defined as the time from the date of randomization to death from any cause
Time frame: From date of first treatment until date of death from any cause, assessed up to 96 months