A cohort study confirming the negative rate of minimal residual disease in transplant ineligible patients with multiple myeloma receiving lenalidomide maintenance after bortezomib, lenaildomide, and dexamethasone (VRD) regime
- Conditions
- Neoplasms
- Registration Number
- KCT0009701
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 147
Age 19 and above.
Diagnosis of symptomatic multiple myeloma according to the International Myeloma Working Group (IMWG) criteria.
Patients undergoing VRD (Bortezomib, Lenalidomide, Dexamethasone) induction therapy.
Patients ineligible for autologous hematopoietic stem cell transplantation, due to:
Inappropriateness based on advanced age.
Inappropriateness due to comorbid conditions.
Patients with measurable disease in multiple myeloma:
Serum M-protein = 0.5 g/dL.
Urine M-protein = 200 mg/24 hr.
Serum free light chain (FLC) assay: a difference = 10 mg/dL (100 mg/L) between involved and uninvolved FLC (if serum EP or urine EP cannot be measured, serum FLC ratio should be abnormal - Kappa/Lambda ratio < 0.26 or > 1.65).
Voluntary consent acquisition.
1. Within the last 6 months, a history of acute coronary syndrome (myocardial infarction, unstable angina), NYHA Class III-IV heart failure, uncontrolled ventricular arrhythmias without implanted pacemaker, or clinically significant cardiac conduction abnormalities not controlled by treatment (e.g., complete heart block).
2. Uncontrolled hypertension (average systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg).
3. Acute leukemia, POEMS syndrome, Waldenstrom macroglobulinemia.
4. Requirement for systemic antibiotics, antiviral drugs, antifungal drugs, or other treatments for an active infection within 1 week prior to the start of the study, and the infection is not under control.
5. Patients with HIV infection, hepatitis B, and hepatitis C (allowed if appropriately treated with antiviral therapy for hepatitis B and C).
6. Severe or uncontrolled internal medical conditions, abnormal laboratory results, or psychiatric abnormalities that, in the investigator's judgment, would make study participation difficult.
7. Cases where necessary concomitant drug use or conservative treatment is contraindicated. For example, hypersensitivity reaction to antiviral drugs or inability to administer fluids due to underlying cardiovascular or pulmonary disease.
8. Diagnosis of any malignancy other than multiple myeloma within the past 3 years. Exceptions include well-controlled non-melanoma skin cancer, carcinoma in situ of the cervix or breast, early-stage prostate cancer, or well-differentiated thyroid cancer that has been adequately treated or does not require immediate treatment.
9. Women of childbearing potential or men who have not undergone sterilization and plan to become pregnant during the study period or are not planning to use a medically accepted method of contraception (e.g., partner's sterilization, intrauterine device, barrier method, abstinence, or condom) even if not planning to become pregnant.
10. Pregnant or breastfeeding.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method sustainded M RD negative rate
- Secondary Outcome Measures
Name Time Method Overall response rate