K cell therapy for myeloma MRD after ASCT
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-jRCTc030190234
- Lead Sponsor
- Junji Tanaka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 20
1.Multiple myeloma diagnosed by IMWG diagnostic criteria
2.Age: 20=<, 65>=
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: adverse events
- Secondary Outcome Measures
Name Time Method Minimal residual disease, overall survival and progression free survival, response rate