None listed
Conditions
Interventions
Drug : Bortezomib was administered intravenously or subcutaneously at 1.3 mg/m² on Days 1 and 15 of each 28-day cycle.
Lenalidomide was administered orally at 10 mg/day (with dose reductions permitted
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 19 years at screening 2. Patients with newly diagnosed multiple myeloma (MM) according to the International Myeloma Working Group criteria, who have completed autologous hematopoietic stem cell transplantation and have no relapse and adequate bone marrow function 3. Those who meet the definition of a high-risk group for relapse 4. Eastern Cooperative Oncology Group performance status (PS) = 2 5. Not pregnant. 6. Confirmed intention to use contraception from the start of maintenance therapy until 90 days after the end. 7. Confirmed intention not to donate gametes from the start of maintenance therapy until 90 days after the end. 8. Not breastfeeding and not planning to breastfeed until 90 days after the last dose of the investigational drug. 9. Patients who voluntarily agreed to participate in the clinical trial through written informed consent.
Exclusion criteria
Exclusion criteria: 1. Clinically significant hematologic disorders or comorbidities: Plasma cell leukemia (circulating plasma cells > 20% or absolute plasma cell count > 2 × 10?/L) Amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome Active central nervous system (CNS) involvement or myelomatous meningitis 2. Clinically significant cardiovascular disorders: Acute myocardial infarction, unstable angina, acute coronary syndrome, or related interventions (e.g., coronary artery bypass grafting, angioplasty, or stent placement) within the past 6 months Thromboembolic events (excluding central venous catheter complications) such as stroke, pulmonary embolism, or deep vein thrombosis within the past 3 months Heart failure, pericardial effusion, or uncontrolled supraventricular arrhythmias 3. Neurological disorders: Grade = 3 peripheral neuropathy (sensory or motor) Neurological abnormalities interfering with activities of daily living History of grade = 3 peripheral motor polyneuropathy 4. Active infections: Active hepatitis B (HBsAg positive, detectable HBV DNA) Active hepatitis C (HCV antibody positive with RNA positive) HIV positive Uncontrolled COVID-19 or other serious infections 5.Abnormal organ function or laboratory tests: Left ventricular ejection fraction (LVEF) 2 × ULN (excluding cases with Gilbert syndrome) AST or ALT > 2.5 × ULN Corrected serum calcium > 14 mg/dL eGFR < 30 mL/min/1.73 m² 6. Medical history: Major surgery or radiotherapy within the past 4 weeks Chemotherapy, immunotherapy, vaccination, or other investigational drug administration within the past 4 weeks Previous therapy intended for maintenance Administration of live attenuated vaccines within 4 weeks prior to study initiation if unavoidable 7.Other: Suicidal ideation or behavior within the past 12 months Acute effects from prior therapy not resolved to baseline (CTCAE = grade 1) Known hypersensitivity to the investigational drug or excipients Investigator judgment that patient safety or study participation cannot be ensured
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-month Progression-Free Survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity and side effects during progression-free survival;Rates of very good partial response or better;Safety and Effectiveness;Minimal Residual Disease | — |
Countries
Korea, Republic of
Contacts
Public ContactSeungMin Jun
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed