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

Inclusion Criteria: I1. Active multiple myeloma, as defined by the IMWG criteria. I2. Evidence of measurable disease: I3. Serum monoclonal (M)-protein ≥1.0 g/dL measured using serum proteinimmunoelectrophoresis a.and/or I4. Urine M-protein ≥200 mg/24 hours measured using urineprotein immunoelectrophoresis a. and/or I5. in patients without measurable M protein in serum or urine as per previouscriteria, serum immunoglobulin free light chain (sFLC) ≥10 mg/dL and abnormal serumimmunoglobulin kappa lambda free light chain ratio <0.26 or >1.65. I6. Patients who are newly diagnosed and considered for high-dose chemotherapy I7. Patienthas given voluntary written informed consent before performance of any study relatedprocedures not part of normal medical care, with the understanding that consent may bewithdrawn by the patient at any time without prejudice to his/her medical care. I8. ≥18 years of age (and satisfying the legal age of consent in the jurisdiction in whichthe study is taking place) I9. Eastern Cooperative Oncology Group (ECOG) performance statusscore of 0 or 1 I10. Male or Female

1. Male participants A male participant must agree to use contraception of this protocolduring the intervention period and for at least 5 months after the last dose of studytreatment and refrain from donating sperm during this period.
2. Female participants A female participant is eligible to participate if she is not pregnant, not breastfeeding,and at least one of the following conditions applies: Not a Females of childbearing potential (FCBP), OR A FCBP who must have a negative serum orurine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior toand again within 24 hours of starting study medication and must either commit to continueabstinence from heterosexual intercourse or apply a highly effective method of birthcontrol until at least 5 months after last dose of study treatment Screening #2 (Conducted after HDT): Inclusion criteria as for first screening in addition to response evaluation (at leastpartial remission must be met).

Exclusion Criteria: E1. Prior or concurrent exposure to NK cells and NK like T cells, or Approved orinvestigational treatments for MM. E2. Received any investigational drug within 14 days or 5 half-lives of the investigationaldrug, whichever is longer. E3. Diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance,or smoldering multiple myeloma (asymptomatic multiple myeloma with absence of related organor tissue impairment end organ damage). E4. Diagnosis of Waldenström's disease, or other conditions in which IgM M-protein ispresent in the absence of a clonal plasma cell infiltration with lytic bone lesions. E5. Prior or current systemic therapy, or SCT for symptomatic multiple myeloma, with theexception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for 4 days) of corticosteroids, if completed within 14 days prior to randomization. E6. Concomitant plasma cell leukemia. E7. Any major procedure within 14 days before theinitiation of the study treatment: plasmapheresis, major surgery (kyphoplasty is notconsidered a major procedure), radiotherapy (except if palliative intent). E8. ECOG PS >2. E9. Hemoglobin <8 g/dL. E10. Platelets <70 × 109/L if <50% of bone marrow (BM) nucleated cells are plasma cells, and ≤30 × 109/L if ≥50% of BM nucleated cells areplasma cells. Platelet transfusion is not allowed within 3 days before the screeninghaematological test. E11. Total bilirubin >1.5 × upper limit of normal (ULN), except for known Gilbert syndrome. E12. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 × ULN. E13. Hypersensitivity (or contraindication) to dexamethasone, sucrose histidine (as baseand hydrochloride salt), boron, mannitol, and polysorbate 80 or any of the components ofstudy therapy that are not amenable to premedication with steroids, pregelatinized starch,sodium stearyl fumarate, arginine hydrochloride, poloxamer 188, sucrose or any of the othercomponents of study therapy that are not amenable to premedication with steroids and H2blockers or would prohibit further treatment with these agents. E14. Any of the following within 6 months prior to randomization: E15. Second/third degree heart block E16. Poorly controlled hypertension E17. Myocardialinfarction E18. Severe/unstable angina pectoris E19. Coronary/peripheral artery bypassgraft E20. New York Heart Association class III or IV congestive heart failure E21. Grade ≥3 arrhythmias E22. Stroke or transient ischemic attack. E23. Left-ventricular ejectionfraction <40%. E24. Prior malignancy. Adequately treated basal cell or squamous cell skin,or superficial (pTis, pTa, and pT1) bladder cancer, or low risk prostate cancer, or any insitu malignancy after curative therapy are allowed, as well as any other cancer for whichcytotoxic chemotherapy has been completed ≥3 years prior to enrolment and from which thepatient has been disease-free for ≥3 years. E25. Known acquired immunodeficiency syndrome (AIDS)-related illness or known HIV diseaserequiring antiviral treatment or active hepatitis A (defined as positive HA antigen), B (defined as either positive HBs antigen or negative HBs antigen with positive HBcantibody), or C infection (defined as a known positive hepatitis C antibody result andknown quantitative hepatitis C (HCV) ribonucleic acid (RNA) results greater than the lowerlimits of detection of the assay).