Multiple myeloma. Multiple myeloma
Conditions
Sponsors
Shahid Beheshti University of Medical Sciences
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: The presence of at least one of the followings: more than 0.5 g/dl M-protein in serum protein electrophoresis, excretion of at least 200 mg of M-protein in urine, more than 10 mg/dL immunoglobulin free light chain in serum Relapse confirmation based on International Myeloma Working Group Refractory to at least two treatment regimens (an immunomodulatory drug, a proteasome inhibitor drug) High-risk multiple myeloma according to the International Myeloma Working Group: "recurrence within 12 months after the previous autologous transplant or progression of the disease within 1 year since the diagnosis of the disease" or "the presence of any of the high-risk cytogenetic cases including t(4;14), t (14;16), (14;20)t, chromosome gain/amplification (+1q21), deletion of the short arm of chromosome 17 (del(17p))"
Exclusion criteria
Exclusion criteria: Insufficiency of engraftment parameters: WBC less than1000/µl, Platelets less than 20000/µl, Hemoglobin less than 8g/dL Total bilirubin greater than 2mg/dL Creatinine greater than 2mg/dL Renal clearance less than 30 mL/min Liver enzymes more than 2.5 times the upper limit of normal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients who show adverse effects during or after NK cell therapy. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: The patient's statements and the medical team's examinations during the patient's regular visits to the bone marrow transplantation clinic for follow-up.;Overall survival in patients after NK cell therapy. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients.;Response to treatment based on criteria defined by the International Multiple Myeloma Working Group (IMWG). Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient examination in bone marrow transplantation clinic for follow-up and based on criteria defined by the International Multiple Myeloma Working Group (IMWG). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactElham Roshandel
Shahid Beheshti University of Medical Sciences
Outcome results
None listed