Multiple myeloma Multiple myeloma
Conditions
Interventions
NK cell infusion therapy with Elotuzumab-Lenalidomide-Dexamethasone for a minimal residual disease of multiple myeloma after autologous stem cell transplantation
Sponsors
Junji Tanaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Multiple myeloma diagnosed by IMWG diagnostic criteria 2.Age: 20== 3.ECOG Performance status0-2 4.PR or better after induction therapy 5. Transplant eligible patients without severe organ damages 6.Autologous mononuclear cell>=0.5x10E10 were obtained when autologous stem cell harvest 7. Patients failed to achieve sCR afterstem cell transplantation or minimal residual disease was detected by 6-8 color Flow cytometry. 8. Patients who are expected to live more than 3 months. 9. Written informed consent was obtained.
Exclusion criteria
Exclusion criteria: 1. Patients who were previously transplanted. 2. Failed to obtain more than 2x10E6/kg of CD34+ cells 3. Patients who are not harvested or transplant eligible due to cardiac or pulmonary disorder. AST,ALT, Total bilirubin>2.5xlower limit, serum Cr>=2.0mg/dl 4. Pregnant or breastfeeding 5. With uncontrollable active infection 6. Patients who have a severe allergy 7. HIV positive, HBV antigen-positive or HBV-DNA positive by PCR patients 8. Without written informed consent 9. For medical reasons, patients who are judged as inappropriate by doctors or researchers. 10. Patient with other active malignancies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Minimal residual disease, overall survival and progression free survival, response rate | — |
Countries
Japan
Contacts
Public ContactShotaro Hagiwara
Tokyo Women's Medical University, Hospital
Outcome results
None listed