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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2032
  • participants needed
    60
  • sponsor
    Karolinska Institutet
Updated on 7 December 2021
measurable disease
cell transplantation
chemotherapy regimen

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.

Details
Condition Lymphoproliferative disorders, multiple myeloma (mm), Lymphoproliferative Disorder, Multiple Myeloma
Treatment Isatuximab, CellProtect
Clinical Study IdentifierNCT04558931
SponsorKarolinska Institutet
Last Modified on7 December 2021

Eligibility

Yes No Not Sure

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 protein
immunoelectrophoresis a.and/or I4. Urine M-protein 200 mg/24 hours measured
using urine protein immunoelectrophoresis
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understanding that consent may be withdrawn by the patient at any time without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)
Inclusion criteria as for first screening in addition to response evaluation
(at least partial remission must be met)

Exclusion Criteria

E1. Prior or concurrent exposure to NK cells and NK like T cells, or Approved
or investigational treatments for MM
E2. Received any investigational drug within 14 days or 5 half-lives of the
investigational drug, whichever is longer
E3. Diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined
significance, or smoldering multiple myeloma (asymptomatic multiple myeloma
with absence of related organ or tissue impairment end organ damage)
E4. Diagnosis of Waldenstrm's disease, or other conditions in which IgM
M-protein is present 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 the exception of an emergency use of a short course (equivalent
of dexamethasone 40 mg/day for 4 days) of corticosteroids, if completed within
days prior to randomization
E6. Concomitant plasma cell leukemia. E7. Any major procedure within 14 days
before the initiation of the study treatment: plasmapheresis, major surgery
(kyphoplasty is not considered 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 are plasma cells. Platelet transfusion is not allowed within 3
days before the screening haematological 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 base and hydrochloride salt), boron, mannitol, and polysorbate
or any of the components of study therapy that are not amenable to
premedication with steroids, pregelatinized starch, sodium stearyl fumarate
arginine hydrochloride, poloxamer 188, sucrose or any of the other components
of study therapy that are not amenable to premedication with steroids and H2
blockers 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
Myocardial infarction E18. Severe/unstable angina pectoris E19
Coronary/peripheral artery bypass graft 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 ejection fraction <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 in situ malignancy after curative therapy are allowed, as well as any
other cancer for which cytotoxic chemotherapy has been completed 3 years prior
to enrolment and from which the patient has been disease-free for 3 years
E25. Known acquired immunodeficiency syndrome (AIDS)-related illness or known
HIV disease requiring antiviral treatment or active hepatitis A (defined as
positive HA antigen), B (defined as either positive HBs antigen or negative
HBs antigen with positive HBc antibody), or C infection (defined as a known
positive hepatitis C antibody result and known quantitative hepatitis C (HCV)
ribonucleic acid (RNA) results greater than the lower limits of detection of
the assay)
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