Treatment for relapsed multiple myeloma using carfilzomib, lenalidomide, and dexamethasone followed by a second stem cell transplant
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
This study is testing a new treatment plan with carfilzomib, lenalidomide, and dexamethasone followed by a second stem cell transplant to see if it helps people aged 20 to 70 with relapsed multiple myeloma feel better after their first transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05497102 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of a treatment regimen involving carfilzomib, lenalidomide, and dexamethasone (KRD) followed by a second autologous stem cell transplantation (ASCT) in patients with relapsed multiple myeloma after their first ASCT. Participants aged 20 to 70 years will receive six cycles of KRD, and those who achieve at least a partial response will proceed to the second ASCT and receive lenalidomide maintenance for 18 months. The study aims to assess treatment responses using established criteria and monitor safety profiles throughout the treatment duration.
Who should consider this trial
Good fit: Ideal candidates are patients aged 20 to 70 who have experienced progressive disease after their first ASCT and have had a response duration of more than 12 months.
Not a fit: Patients who have prior refractory multiple myeloma or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with relapsed multiple myeloma, potentially leading to longer remission periods.
How similar studies have performed: Other studies have shown promising results with similar treatment approaches in relapsed multiple myeloma, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Kihyun Kim, M.D., Ph.D — Samsung Medical Center
- Study coordinator: Kihyun Kim, M.D., Ph.D
- Email: kihyunk.kim@samsung.com
- Phone: 82-2-2148-7333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.