None listed
Conditions
Interventions
Drug : Daratumumab-Lenalidomide-Dexamethasone combination therapy is 28 days as one cycle.
Daratumumab is administered at a dose of 16 mg/kg when administered once. For the first two cycles, dosing is
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 19 years old or older - less than 75 years old 2. Patients with relapsed or refractory multiple myeloma according to the IMWG standard (refer to “19. Matters necessary for the safe and scientific implementation of clinical research”) 3. A patient who satisfies the following as a diagnosis of multiple myeloma (satisfied with A and B) A. Bone marrow monoclonal plasma cells =10% or biopsy confirmed plasmacytoma B. Patients with evaluable multiple myeloma and one or more of the following: i. Serum M-protein =1.0 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) =10 mg/dL and abnormal serum kappa/lambda free light chain ratio 4. Patients previously treated with lenalidomide 5. Multiple myeloma that has failed at least three treatments, including proteasome inhibitors and immunomodulators, respectively. 6. Patients not previously treated with antibodies to CD38 7. Eastern Cooperative Oncology Group Performance Status 0-2 8. With normal heart function (Ejection fraction =50%) 9. With normal renal function (Creatinine clearance = 15 ml/min) 10. In case of adequate liver function (serum total bilirubin less than 2.5 times the upper limit of normal, AST/ALT less than 2.5 times of the upper limit of normal) 11. Adequate bone marrow function (neutrophil count 1,000/ul or more, platelet count 50,000/ul or more) 12. Negative serum or urine pregnancy test before starting treatment (at the time of screening); For premenopausal women or women who have had amenorrhea within 1 year (within 1 year after menopause) * Women of childbearing age are informed of contraceptive methods such as natural cycle method and abstinence according to the Catholic ideology of our institute. When obtaining the consent form for women of childbearing potential, the method of contraception is explained to the subject.
Exclusion criteria
Exclusion criteria: 1. Primary amyloidosis, Smoldering multiple myeloma, indeterminate significant monoclonal gamma globulinemia (MGUS) 2. Patients with a history of cancer other than non-melanoma skin cancer and in situ carcinoma of cervix uteri that have been cured within the last 5 years 3. Patients who had side effects that prevented them from maintaining their anticancer drugs during previous chemotherapy including lenalidomide 4. Patients who have previously received other antibody therapy including daratumumab 5. Patients with or suspected of having or suspected of having chronic obstructive pulmonary disease (COPD) or asthma (including a history of asthma within 2 years) with an FEV1 < 50% must perform a pulmonary function test at screening – To perform a pulmonary function test In difficult cases, the mMRC respiratory distress score (refer to “19. Other matters necessary for the safe and scientific implementation of clinical research”) is substituted, and an mMRC score of 3 or higher cannot be enrolled in the study. 6. HIV positive 7. Active hepatitis B or C 8. Accompanying mental illness that makes it difficult to participate in this study 9. Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression- free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Overall response rate;Rates of very good partial response or better;Toxicity and side effects during progression-free survival;Secondary progression-free survival;Overall response rate according to secondary treatment in patients who received secondary treatment | — |
Countries
Korea, Republic of
Contacts
Public ContactSeungMin Jun
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed