None listed
Conditions
Interventions
None listed
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female aged 19 to less than 72 years. Patients with multiple myeloma according to IMWG criteria ("19. Miscellaneous" for safe and scientifically valid clinical trials). Patients diagnosed with multiple myeloma who meet the following criteria (all must be met): Monoclonal plasma cells in the bone marrow. =10% monoclonal plasma cells confirmed by tissue examination. Patients with evaluable multiple myeloma and one or more of the following: i. Serum M-protein = 0.5 g/dL or urine M-protein = 200 mg/24 hours. ii. IgA multiple myeloma: Serum M-protein = 0.5 g/dL or urine M-protein = 200 mg/24 hours. iii. Light chain multiple myeloma: Serum free light chain (sFLC) = 100 mg/L and abnormal serum kappa/lambda FLC ratio. Patients starting or receiving one of the following immunotherapy treatments for multiple myeloma: I. Lenalidomide-containing combination therapy for multiple myeloma: (1) Lenalidomide-Dexamethasone (2) Daratumumab-Lenalidomide-Dexamethasone (3) Bortezomib-Lenalidomide-Dexamethasone (4) Ixazomib-Lenalidomide-Dexamethasone (5) Carfilzomib-Lenalidomide-Dexamethasone II. Maintenance therapy after autologous hematopoietic stem cell transplantation: (6) Lenalidomide monotherapy *The 6 lenalidomide-based therapeutic regimens listed above are currently covered by health insurance in the Korean medical field as combination therapy or monotherapy. Presence of renal dysfunction: eGFR < 50 mL/min. Patients with adequate liver function (all must be met): Serum total bilirubin less than 2 times the upper limit of normal (except in cases of Gilbert's syndrome, less than 3 times the upper limit of normal). AST/ALT less than 2.5 times the upper limit of normal. Eastern Cooperative Oncology Group Performance Status 0-2. Normal cardiac function (Ejection fraction =45%). Adequate bone marrow function (all must be met)*: Neutrophil count = 1,000/µL. Platelet count = 70,000/µL. Hemoglobin = 9 g/dL. *Allowance for application of granulocyte colony-stimulating factor or blood transfusions at screening or before screening. For female participants: Postmenopausal women with amenorrhea for = 1 year. Pre-menopausal women with negative pregnancy test before treatment initiation (at the time of screening) and who can maintain contraception during the study period [limited to pre-menopausal women or women with amenorrhea for less than 1 year (within 1 year after menopause)]. *During the consent process for fertile women, participants are informed of contraception methods such as natural cycle methods and abstinence according to the Catholic ideology of the hospital.
Exclusion criteria
Exclusion criteria: Asymptomatic smoldering multiple myeloma, active plasma cell leukemia, monoclonal gammopathy of undetermined significance (MGUS), amyloidosis or multiple myeloma involving the central nervous system. Active cardiovascular dysfunction. HIV positive. Active hepatitis A, B*, or C. *May participate if evidence of hepatitis B (HBV) infection exists but HBV DNA is not detected through antiviral therapy. Currently undergoing treatment or requiring treatment for any cancer other than multiple myeloma. History of any cancer other than melanoma or in situ carcinoma of the cervix uteri that has been cured within the past 5 years. Peripheral neuropathy with severity grade 3 or above or peripheral neuropathy symptoms with severity grade 2 or above accompanied by pain. Participation in another clinical trial involving administration of an anti-neoplastic agent within the past 3 weeks. Concurrent severe mental illness making participation in the study difficult. Pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to reach maximum plasma concentration (Tmax) from administration of lenalidomide | — |
Secondary
| Measure | Time frame |
|---|---|
| The area under the curve (AUC0-24) until the final sampling time.; The elimination rate constant (?z).;The final half-life (t1/2) calculated from ?z.;Oral clearance (CL/F) and volume of distribution (V/F) calculated from the area under the curve. | — |
Countries
Korea, Republic of
Contacts
Public ContactSeungMin Jun
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed