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
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.
⁃ 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 protein immunoelectrophoresis a.and/or I4. Urine M-protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis
⁃ a. and/or I5. in patients without measurable M protein in serum or urine as per previous criteria, serum immunoglobulin free light chain (sFLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio \<0.26 or \>1.65.
⁃ I6. Patients who are newly diagnosed and considered for high-dose chemotherapy I7. Patient has given voluntary written informed consent before performance of any study related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to his/her medical care.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 which the study is taking place) I9. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 I10. Male or Female
• Male participants A male participant must agree to use contraception of this protocol during the intervention period and for at least 5 months after the last dose of study treatment and refrain from donating sperm during this period.
• 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 or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting study medication and must either commit to continue abstinence from heterosexual intercourse or apply a highly effective method of birth control until at least 5 months after last dose of study treatment
⁃ Screening #2 (Conducted after HDT):