Multiple myeloma in relapse. Multiple myeloma in relapse
Conditions
Interventions
Intervention group: A single infusion of BCMA CAR NK cells, The patient is brought to the isolation room 4 days before receiving CAR-NK cells and gets a chemotherapeutic conditioning treatment (days
Sponsors
Tehran University of Medical Sciences
Payesh company
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years with expected survival > 3 months. 2. Confirmed diagnosis of active multiple myeloma with detectable BCMA expression in malignant cells. 3. Relapsed or refractory disease with at least 2 prior lines of treatment, including a proteasome inhibitor and immunomodulator, without achieving significant efficacy. 4. Measurable disease at screening according to IMWG criteria, as defined by any of the following: Serum monoclonal paraprotein (M-protein) level =1.0 g/dL or urine M-protein level being as defined; or light chain MM without measurable disease in the serum or the urine; serum immunoglobulin free light chain disease dL and abnormal serum immunoglobulin kappa/lambda free light chain ratio. 5. ECOG performance status of 0-1. 6. Acceptable cardiac, liver, and kidney function. 7. Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Uncontrolled active infection, HIV infection, or positive syphilis serology reaction. 3. Active hepatitis B or hepatitis C infection. 4. Recent or current use of glucocorticoids or other immunosuppresses. 5. Severe cardiac, liver, renal insufficiency, diabetes, or other diseases. 6. Participation in other clinical research in the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicity (DLTs). Timepoint: Daily during the first seven days after the injection and then weekly until 4 weeks. Method of measurement: History, Physical exam, and lab test.;Overall Remission Rate (ORR). Timepoint: 8 weeks after CAR-NK cells infusion. Method of measurement: Assessed using International Myeloma Working Group (IMWG) criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS). Timepoint: 48 weeks after CAR-NK cells infusion. Method of measurement: Assessed using IMWG criteria.;Duration of Response (DOR). Timepoint: 48 weeks after CAR-NK cells infusion. Method of measurement: Assessed using IMWG criteria. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMasoud Soleimani
Shahid Beheshti University of Medical Sciences
Outcome results
None listed