Phase II, single-arm trial of carfilzomib, lenalidomide, and dexamethasone re-induction followed by the 2nd ASCT in multiple myeloma patients relapsed after the 1st ASCT
- Conditions
- Neoplasms
- Registration Number
- KCT0005635
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 58
1. Age 20~70
2. Progressive disease after 1st ASCT
3. Duration of response after 1st ASCT > 12 months
4. Measurable disease (+)
• Serum M-protein = 1 g/dL
• Urine M-protein = 200 mg/24 hr
• Serum Free Light Chain(FLC) assay: involved FLC level =10 mg/dL
(serum Free Light Chain ratio is abnormal)
5. Adequate organ function for induction & ASCT
• Absolute Neutrophil Count (ANC) = 1.0 x 109/L
• Platelets = 50 x 109/L (= 30 x 109/L if myeloma involvement is >
50% in the bone marrow)
• Hemoglobin = 8.0 g/dL
• Creatinine clearance = 30 mL/minute
• Serum Bilirubin = 1.5 x upper limit of normal
• Aspartate aminotransferase(AST) and Alanine
aminotransferase(ALT) = 3 x upper limit of normal
6. Eastern Cooperative Oncology Group performance scale 0~2
7. Survival expectancy > 3 months
8. Adequately controlled hepatitis B(HBV) & hepatitis C(HCV)
9. Written informed consent
10. Optimal contraceptions
1. Prior refractoriness or intolerance to carfilzomib
2. Prior refractoriness or intolerance to lenalidomide/dexamethasone
3. Any treatment after progressive disease after 1st ASCT. High-dose
dexamethasone or palliative radiation is permitted.
4. Waldenstroem’s macroglobulinemia, POEMS syndrome, or plasma cell
leukemia
5. Pregnant or nursing lactating women
6. Myocardial infarct within 6 months, heart failure of New York Heart
Association(NYHA) Class III~IV, uncontrolled ventricular arrhythmia,
severe coronary arterial obstructive disease
7. Uncontrolled hypertension (Defined as an average systolic blood
pressure >= 160 mmHg or diastolic >= 100 mmHg) or diabetes
8. Grade 3~4 neuropathy
9. HIV infection
10. Severe or uncontrolled medical conditions, laboratory abnormalities, or
psychiatric disorders that may preclude the participation of the study by
the physician’s discretion
11. Contraindication to any of the required concomitant drugs or supportive
treatments, including hypersensitivity to all anticoagulation and
antiplatelet options, antiviral drugs, or intolerance to hydration due to
preexisting pulmonary or cardiac impairment
12. Diagnosis of other malignant disease other than myeloma within 5
year. Exceptions are properly treated non-melanomatous skin cancers,
cervical intraepithelial neoplasia, prostate cancer that do not require
treatment, or properly excised well-differentiated thyroid cancers
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-year progression free survival rate
- Secondary Outcome Measures
Name Time Method Complete response rate after KRd #6;Complete response rate after ASCT;Overall response rate;Time to response;Duration of response;Progression free survival;Overall survival;Safety profiles;Rate of the successful stem cell harvest