Multiple Myeloma
Conditions
Keywords
NK cells, Consolidation
Brief summary
Multiple Myeloma (MM) is a lethal disease and at present no available treatment method seems to prevent the disease from progressing or relapsing in the long term. NK cells have a relatively high cytotoxic capacity and an anti tumour effect, suggesting a potential as a treatment of MM.This is a phase I, first-in-human, therapeutic exploratory study, where no benefits for the patients can be guaranteed. However, the theoretical implication is that the infused cells may have a positive antitumour effect for the participating individuals.
Interventions
Autologous ex vivo expanded and activated NK cells
Sponsors
Karolinska University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed Informed Consent 2. Above 18 years of age 3. MM diagnosis (stage I-III according to the International Staging System) 4. Eligible for, and willing to undergo, high dose chemotherapy and ASCT 5. Measurable monoclonal immunoglobulins 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 7. Life expectancy of at least three months
Exclusion criteria
1. Non-secretory MM 2. Malignancy, other than MM, treated with chemotherapy or radiation within the past six months 3. Blood donation or other significant blood loss within three months from screening 4. Any physical condition or laboratory results that contraindicate a blood donation to be performed within four weeks from screening 5. Any physical condition or laboratory results that require the chemotherapy to start before there is available slot for blood donation 6. Known or suspected allergic reactions to any ingredient of the IP 7. Diagnosis or indication of any active autoimmune disease, such as Rheumatoid Arthritis, Inflammatory Bowel Disease, Systemic Lupus Erythematosis or Multiple Sclerosis 8. Uncontrolled or severe cardiovascular disease, such as myocardial infarction within six months from screening, heart failure (class III or IV according to New York Heart Association), uncontrolled angina, clinically significant pericardial disease or cardiac amyloidosis 9. Poorly controlled hypertension 10. Poorly controlled Diabetes Mellitus, type I or II 11. Diagnosis or indication of any clinically relevant renal disease 12. Diagnosis or indication of any clinically relevant hepatic disease 13. Ongoing infection that is considered chronic 14. Known or suspected drug or alcohol abuse, within 12 months from screening 15. Pregnant, trying to become pregnant, or nursing 16. Lack of, or unreliable contraceptive method, as judged by the Investigator 17. Medical history or any abnormal physical finding that is clinically relevant and could interfere with the safety or objectives of the study, as judged by the Investigator 18. Lack of suitability for participation in the trial, for any reason, as judged by the Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | From first dose of study treatment up until six months from last infusion. | Assessment of treatment-emergent adverse events/serious adverse events (TEAEs/SEAS)(including IARS). TEAEs are defined as AEs that develop, worsen (according to the Investigators opinion), or bedome serious during the treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes on serum monoclonal immunoglobulin levels as a marker of efficacy | From date of screening through study completion, up until six months from last infusion | Changes in absolute and relative levels of laboratory parameters |
| Changes on urine monoclonal immunoglobulin levels as a marker of efficacy | From date of screening through study completion, up until six months from last infusion | Changes in absolute and relative levels of laboratory parameters |
| Changes on serum free light chain levels as a marker of efficacy | From date of screening through study completion, up until six months from last infusion | Changes in absolute and relative levels of laboratory parameters |
| Effect of CellProtect on plasma cell fraction in bone marrow | From date of screening up until one month from last infusion | Changes in bone marrow clonal plasma cells |
| Response assessment as defined by the International Myeloma Working Group uniform response criteria | From date of screening up until six months from last infusion | Evaluation of response criteria, i.e. minimal response, partial response, very good partial response and complete response as assessed by International Myeloma Working Group uniform response criteria |
Countries
Sweden
Outcome results
None listed