multiple myeloma
Conditions
Interventions
Switched ERd from Rd is started with weekly elotuzumab at first 2 cycles following monthly administration. ERd is continued until the decision to stop due to ineffectiveness, adverse event or patients
Sponsors
North Japan Hematology Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients are >= 20 years of age at consent 2. Patients under Rd therapy 3. Patients who achieved >= partial response but not achieved stringent CR 4. Patients ineligible for autologous transplant or who already have undertaken autologous transplant 5. Patients with ECOG performance status 0,1 or 2 6. Patients with normal function of major organ function except for kidney a. Ejection fraction >= 50% at ultrasonic cardiography b. Total bilirubin <= 2.0 mg/dL and AST/ALT <= 4xULN c. SpO2 >= 95% at room air 7. Patients who fully understood this study with sufficient description and agreed by written consent.
Exclusion criteria
Exclusion criteria: 1. Patients with HIV-antibody positive 2. Patients with synchronous or metachronous malignancy except carcinoma in situ or cancer confined to the mucosa and curatively treated by local resection 3. Patients with active infectious disease 4. Pregnant women, women who could be pregnant or women who is breast feeding 5. Patients with history of hypersensitivity for the component of elotuzumab 6. Patients with other inadequate conditions determined by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The improvement rate of best response until 12 months after switching to elotuzumab plus lenalidomide and dexamethasone | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival and overall survival rate at 1 and 2-year 2. Overall survival rate at 1 and 2-year 3. The improvement rate of best response until 24 months after switching to elotuzumab plus lenalidomide and dexamethasone 4. The time to best response 5. Duration of response 6. The time to treatment failure 7. The time to next treatment for MM 8. The change of level of immunoglobulin and free light chain (for 24 months) 9. The change of lymphocyte subset in peripheral blood (for 12 months) 10. Safety of elotuzumab plus lenalidomide and dexamethasone (Incidence rate of grade 3 and 4 adverse event) | — |
Countries
Japan
Contacts
Public ContactKatsuya Fujimoto
Hokkaido Cancer Center Department of Hematology
Outcome results
None listed