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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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performance of any study related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to his/her medical care.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):

Locations
Other Locations
Sweden
Karolinska University Hospital, Huddinge
RECRUITING
Stockholm
Contact Information
Primary
Johan Lund, M.D.
johan.l.lund@regionstockholm.se
+46(0)8 58 58 00 00
Time Frame
Start Date: 2021-06-02
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 62
Treatments
Experimental: A - Isatuximab/CellProtect
Isatuximab will be given intravenously (IV) at the dose of 10 mg/kg on Days 1, 8, 15, 22 (cycle 1), 36, 50 (cycle 2), 64, 78 (cycle 3) and monthly thereafter (cycles 4-36).~CellProtect will be given IV infusion at the dose of 3x10\^7 cells/kg day 29 , 43 and 3-10x10\^7 on day 57.~Each cycle will be 28 days, after completion of third cycles, patients will continue with Isatuximab alone until disease progression, unacceptable AE, death, completion of 3 years of treatment or patient's decision to discontinue, whichever occurs first.
Active_comparator: B - Isatuximab
Isatuximab will be given intravenously (IV) at the dose of 10 mg/kg on Days 1, 8, 15, 22 (cycle 1), 36, 50 (cycle 2), 64, 78 (cycle 3) and monthly thereafter (cycles 4-36).~Each cycle will be 28 days, after completion of third cycles, patients will continue with Isatuximab alone until disease progression, unacceptable AE, death, completion of 3 years of treatment or patient's decision to discontinue, whichever occurs first.
Related Therapeutic Areas
Sponsors
Leads: Karolinska Institutet
Collaborators: Sanofi, XNK Therapeutics AB, Sweden

This content was sourced from clinicaltrials.gov