RecruitingPhase 2NCT04558931

Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma

An Open, Randomised, Controlled, Phase II Trial of CellProtect in Combination With Isatuximab Antibody Versus Isatuximab Antibody Alone as Maintenance Treatment in Patients With Multiple Myeloma Undergoing High Dose Treatment


Sponsor

Karolinska Institutet

Enrollment

62 participants

Start Date

Jun 2, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving patients with newly diagnosed multiple myeloma their own immune cells (called NK cells) — either alone or combined with an antibody drug called isatuximab — after standard intensive chemotherapy can help maintain remission longer. **You may be eligible if...** - You are 18 or older with active multiple myeloma - Your myeloma shows measurable disease markers in blood or urine tests - You are newly diagnosed and being considered for high-dose chemotherapy - You are in good general health (ECOG performance status 0 or 1) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are not using adequate contraception (if applicable) - You have significant organ dysfunction unrelated to myeloma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCellProtect

In vitro expanded and activated autologous NK cells

DRUGIsatuximab

Naked immunoglobulin (Ig) G1 monoclonal antibody (mAb) that selectively binds to the human cell surface antigen molecule classified as cluster of differentiation (CD) 38


Locations(1)

Karolinska University Hospital, Huddinge

Stockholm, Sweden

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NCT04558931


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