Overview

Carfilzomib, Lenalidomide, and Dexamethasone Re-induction Followed by the 2nd ASCT in Multiple Myeloma Patients Relapsed After the 1st ASCT

Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of salvage treatment with carfilzomib/lenalidomide/dexamethasone (KRD) followed by 2nd autologous stem cell transplantation (ASCT) and lenalidomide maintenance in patients with relapsed myeloma after 1st ASCT.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Samsung Medical Center
Treatments:
Lenalidomide
Criteria
Inclusion Criteria:

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

Exclusion Criteria:

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