None listed
Conditions
Interventions
Drug : Carfilzomib, Pomalidomide, and Dexamethasone (KPd) regimen (28-day cycle)
• Cycles 1–12 or pre-autologous stem cell transplantation (ASCT) cycles 1–6:
Pomalidomide: 4 mg PO (D1–D21)
Carfilzom
however, the transplant group is limited to a maximum of 15 patients. Eligible patients include those who have not previously undergone ASCT or those whose disease-free interval after first ASCT is =1
otherwise, treatment should continue.
For scheduling reasons, delays of up to 14 days per cycle are allowed without being considered a protocol violation. If delays are due to toxicity, the interval f
if a longer delay is needed, stu
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria to be eligible for enrollment in this study. 1. Patients with multiple myeloma aged =19 years at the time of enrollment. 2. Patients who are refractory or relapsed after prior induction therapy (including prior autologous stem cell transplantation and maintenance therapy). 3. Patients previously exposed to both bortezomib and lenalidomide (with at least 4 cycles of treatment), and refractory to lenalidomide. 4. Patients who have not previously received carfilzomib or pomalidomide. 5. Patients with measurable disease, defined as at least one of the following: Serum M-protein = 0.5 g/dL Urine M-protein = 200 mg/24 hr Serum free light chain (FLC) assay: difference between involved and uninvolved FLC = 10 mg/dL (100 mg/L) If serum or urine electrophoresis cannot be performed, the serum FLC ratio must be abnormal (Kappa/Lambda ratio 1.65). 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0–2. 7. Adequate organ function: Absolute neutrophil count (ANC) = 1.0 × 10?/L Platelet count = 50 × 10?/L (=30 × 10?/L if bone marrow is involved with myeloma) Hemoglobin = 8 g/dL Total serum bilirubin = 3 × ULN 8. Patients able to take oral medication. 9. Patients who understand the purpose of the clinical trial and the procedures involved, and voluntarily agree to participate by signing the informed consent form. Patients must also have the willingness and ability to comply with all prohibited and restricted items stated in the informed consent and in this treatment guideline. 10. Women of childbearing potential (pre-menopausal women or those with amenorrhea within 1 year) must have a negative serum or urine pregnancy test before starting the trial. Two negative results must be confirmed 10–14 days and within 24 hours before treatment initiation.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from enrollment: 1. Patients who have previously been treated with regimens including carfilzomib or pomalidomide. 2. History of acute coronary syndrome (myocardial infarction, unstable angina) within the past 6 months, heart failure NYHA Class III–IV, uncontrolled ventricular arrhythmia, or uncontrolled clinically significant cardiac conduction disorders (e.g., sick sinus syndrome, complete atrioventricular block) without a pacemaker. 3. Left ventricular ejection fraction (LVEF) < 40% on echocardiography or cardiac imaging. 4. Uncontrolled hypertension (mean systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg). 5. AL amyloidosis with cardiac involvement, plasma cell leukemia, POEMS syndrome, or Waldenström macroglobulinemia. 6. History of malignancy other than multiple myeloma within the past 5 years. Exceptions: fully treated skin cancers other than melanoma, cervical, breast, or gastrointestinal carcinoma in situ, and patients with malignancy fully treated or at minimal risk of recurrence within the past 3 years. 7. Serious medical conditions or diseases, including: Severe neurological or psychiatric disorders (e.g., dementia, epilepsy) Active, uncontrolled infection (including HIV, hepatitis B, or hepatitis C) Other serious disease conditions as judged by the investigator Note: Patients receiving appropriate antiviral therapy for hepatitis B or C with controlled infection are allowed. 8. Pregnant or breastfeeding women. 9. Patients with grade =3 peripheral neuropathy (according to NCI-CTCAE v5.0).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival; OS;Complete response rate;Rate of very good partial response (VGPR) or better;Overall response rate, ORR;Duration of response;Time to next treatment;Safety | — |
Countries
Korea, Republic of
Contacts
Public ContactJeungmin Heo
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed