Actively Recruiting
Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma
Led by Karolinska Institutet · Updated on 2023-10-11
62
Participants Needed
1
Research Sites
604 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Active multiple myeloma as defined by IMWG criteria
- Evidence of measurable disease with specified serum or urine monoclonal protein levels or abnormal serum free light chain ratio
- Newly diagnosed patients considered for high-dose chemotherapy
- Age 18 years or older and able to give informed consent
- ECOG performance status of 0 or 1
- Male patients must agree to use contraception during and for 5 months after treatment
- Female patients must not be pregnant or breastfeeding and must use effective birth control if of childbearing potential
- At least partial remission after high-dose therapy before maintenance treatment
You will not qualify if you...
- Prior or concurrent exposure to NK cells or NK-like T cells
- Prior investigational treatments for multiple myeloma within 14 days or 5 half-lives
- Diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma
- Diagnosis of Waldenström's disease or similar conditions with IgM M-protein without clonal plasma cell infiltration
- Prior systemic therapy or stem cell transplant for symptomatic multiple myeloma except short corticosteroid use
- Concomitant plasma cell leukemia
- Major procedures within 14 days before study treatment
- ECOG performance status greater than 2
- Low hemoglobin or platelet counts below specified thresholds
- Elevated bilirubin (except Gilbert syndrome) or liver enzymes above specified limits
- Hypersensitivity to study treatment components
- Certain serious cardiac conditions within 6 months prior to randomization
- Prior malignancy unless disease-free for 3 or more years
- Known AIDS-related illness, HIV requiring antiviral treatment, or active hepatitis A, B, or C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Karolinska University Hospital, Huddinge
Stockholm, Sweden, 17177
Actively Recruiting
Research Team
J
Johan Lund, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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