None listed
Conditions
Interventions
None listed
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 19 years of age or older 2. Multiple myeloma with symptoms diagnosed according to IMWG(International Myeloma Working Group) criteria 3. a patient who underwent autologous hematopoietic stem cell transplantation after the first induction therapy 4. Patients within 10-14 months of receiving lenalidomide maintenance therapy after autologous hematopoietic stem cell transplantation 5. Patients who have achieved more than complete response after autologous hematopoietic stem cell transplantation (However, regardless of the screening time Bone Marrow and Serum & Urine Immunofixation results, the Serum & Urine M-protein value is "0" and only normal FLC ratio can be considered as Complete Response and participate.) 6. Multiple myeloma patients with measurable lesions at diagnosis - Serum M-protein = 0.5 g/dL - M-protein = 200 mg/24 hr - Serum free light chain (FLC) assay: difference between Involved FLC and Involved FLC = 10 mg/dL (100 mg/L) (If serum electrophoresis or urine electrophoresis cannot be measured, serum FLC ratio should be abnormal (Kappa/Lambda ratio 1.65)) 7. Acquisition of voluntary consent
Exclusion criteria
Exclusion criteria: 1. A history of acute coronary syndrome (myocardial infarction, unstable angina) within 6 months, heart failure in NYHA(New York Heart Association) Class III to IV, uncontrolled ventricular arrhythmia, uncontrolled cardiac conduction without pacemaker insertion (motor failure syndrome, complete atrioventricular block, etc.) 2. uncontrolled hypertension 3. plasma cell leukemia, amyloidosis, POEMS syndrome, Valdenstrom macroglobulinemia 4. If the screening test identifies the plasmodium 5. Patients with HIV infection, hepatitis B and C (permitted if they are receiving adequate antiviral therapy for hepatitis B and C) 6. If the researcher deems it difficult to participate in this study due to severe or uncontrolled medical conditions, abnormal test results, or psychiatric abnormalities 7. If necessary combination drug administration or conservative treatment is contraindicated 8. Where a malignant tumor other than multiple myeloma is diagnosed within the last three years. Non-melanoma skin cancer properly treated with exceptions, intraepithelial cancer of the cervix or breast, early gastric cancer, prostate cancer that does not require treatment, or differentiated thyroid cancer that is well resected or does not require immediate treatment, etc 9. In women of fertile or men who have not undergone vasectomy, medically recognized contraception (partner's infertility surgery, partner's intrauterine contraceptive device, liver wall contraception, septum or condom combination) is not available during the study period 10. a pregnant or nursing woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival rate, 4.5 year | — |
Secondary
| Measure | Time frame |
|---|---|
| AE(Adverse Event) caused by lenalidomide maintenance therapy;Overall survival;Development of prognostic biomarkers | — |
Countries
Korea, Republic of
Contacts
Public ContactJIN SEOK KIM
Yonsei University Health System, Severance Hospital
Outcome results
None listed