Phase II study of carfilzomib, pomalidomide, and dexamethasone for multiple myeloma patients who had relapsed or progressed after carfilzomib, lenalidomide, and dexamethasone (KAPPA trial)
- Conditions
- Neoplasms
- Registration Number
- KCT0006285
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 33
1. Age 20-80 years old
2. Recurrent or progressive multiple myeloma after KRd (carfilzomib, lenalidomide, dexamethasone) treatment
3. After 12 cycles of KRd or more, lenalidomide monotherapy for 6 months or more, or autologous stem cell transplantation after 4 to 6 cycles of KRd or more, and lenalidomide maintenance therapy for 6 months or more
4. Measurable lesions
- Serum M-protein = 1 g/dL (10 g/L)
- Urine M-protein = 200 mg/24 hr
- Serum FLC assay: Involved FLC = 10 mg/dL (100 mg/L) (if serum EP or urine EP cannot be measured, serum FLC ratio should be abnormal (KL ratio < 0.26 or > 1.65))
5. Organ function adequate to receive treatment
- Absolute Neutrophil Count (ANC) = 1.0 x 109/L
- Platelet count = 50 x 109/L (= 30 x 109/L if myeloma involvement > 50% on bone marrow examination)
- Hemoglobin = 8.0 g/dL
- Creatinine clearance = 30 mL/minute or serum creatinine <3.0 g/dL
- Serum bilirubin = 1.5 x ULN
- AST and ALT = 3 x ULN
6. Eastern Cooperative Oncology Group performance scale 0~2
7. Life expectancy of 3 months or more
8. Obtaining Voluntary Consent
9. Previously administered bortezomib-based therapy
10. Patients who meet the following criteria
• For women of childbearing age
- Women who are willing to use two reliable methods of contraception from 4 weeks prior to administration of the investigational drug, during treatment, during cessation of administration, and until 4 weeks after administration of the investigational drug
- Women with a negative pregnancy test with a minimum sensitivity of 25 IU/mL under medical management
• If you are male
Men who consented to absolute abstinence or appropriate contraception for the entire duration of treatment and for 28 days after the last dose
?Women of childbearing age
Women who have not undergone hysterectomy or bilateral oophorectomy, women who have not had spontaneous menopause for at least 24 consecutive months (i.e., have menstruated at any time in the past 24 months. However, if amenorrhea after chemotherapy does not rule out pregnancy) not).
? Appropriate method of contraception
• Very effective method
Intrauterine devices, hormone therapy (hormonal implants, intrauterine systems that release levonorgestrel, medroxyprogesterone acetate depot injection, tablets containing ovulation-suppressing progesterone), tubal ligation, vasectomy in men
• Effective way
Male use of condoms, diaphragms, and cervical caps
1. Non-hematologic toxicity of 3 to 4 degrees or greater due to carfilzomib during previous carfilzomib treatment
2. Previously treated with pomalidomide
3. Thalidomide or lenalidomide hypersensitivity
4. carfilzomib refractory according to IMWG criteria
5. History of myocardial infarction within 6 months, NYHA Class III to IV heart failure, uncontrolled ventricular arrhythmias, severe coronary artery disease
6. Active infection within 14 days of study initiation
7. Uncontrolled hypertension (mean systolic =160 mmHg or diastolic =100 mmHg) or uncontrolled diabetes mellitus (HbA1c > 7.0%)
8. HIV-infected, hepatitis B and C patients (acceptable as long as they are receiving appropriate antiviral therapy for hepatitis B and C).
9. In case the researcher judges that participation in this study is difficult due to severe or uncontrolled medical disease, abnormal test result, or psychiatric abnormality
10. When the necessary concomitant drug administration or conservative treatment is contraindicated. For example, if there is a hypersensitivity to anticoagulants or antiviral drugs, or if fluid administration is impossible due to underlying cardiopulmonary disease
11. If you have been diagnosed with a malignancy other than multiple myeloma within the past 5 years. Exceptions include properly treated non-melanoma skin cancer, intraepithelial cancer of the cervix, untreated prostate cancer, or well-resected differentiated thyroid cancer.
12. Pregnant or lactating women
13. Waldenstroem’s macroglobulinemia, POEMS syndrome, or plasma cell leukemia, light chain amyloidosis
14. LV ejection fraction < 40%
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate, ORR
- Secondary Outcome Measures
Name Time Method Complete response rate;progression-free survival;overall survival;duration of response; time to response;safety profile;minimal residual disease