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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0005635

Enrollment

Registered

2020-11-27

Start date

2021-11-04

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Biological/Vaccine, Stem Cell : [KRd #1-6] - Patients who have signed the consent form start administering KRd in 21 days. - Response assessment is conducted every cycle, and if a progressive le

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
2-year progression free survival rate	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactKihyun Kim

Samsung Medical Center

kihyunk@skku.edu+82-2-3410-3456

Outcome results