None listed
Conditions
Interventions
Drug : The patient receives oral ixazomib 4mg on Days 1, 8 and 15 of a 28-day cycle. Pomalidomide 4mg is administered orally on Days 1 through 21. Dexamethasone 40mg is given orally on Days 1,8, 15 an
Sponsors
Pusan National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 19 or older at the time of signing the informed consent form (ICF). 2. Relapsed or progressive multiple myeloma following first-line treatment. 3. Diagnosis of multiple myeloma with measurable disease, defined by at least one of the following: a. M-protein = 0.5 g/dL in serum by serum protein electrophoresis (sPEP), or b. M-protein = 200 mg/24 hours in a 24-hour urine collection by urine protein electrophoresis (uPEP), or c. Serum free light chain (FLC) assay: Difference between involved and uninvolved FLC = 10 mg/dL (100 mg/L); if sPEP and uPEP are not measurable, the serum FLC ratio must be abnormal. 4. Received at least one prior line of therapy for multiple myeloma (i.e., second-line treatment or beyond). 5. Prior exposure to a lenalidomide-containing regimen. 6. Documented disease progression during or after the most recent antimyeloma therapy. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 8. Those who can comply with the pregnancy prevention program
Exclusion criteria
Exclusion criteria: 1. Patients who have received an allogeneic hematopoietic stem cell transplant at any time during prior treatment, or an autologous stem cell transplant within 12 weeks prior to initiating study treatment. 2. Patients with plasma cell leukemia, Waldenström’s macroglobulinemia, POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes), or clinically significant light chain (AL) amyloidosis. 3. Patients known to have central nervous system (CNS) involvement due to multiple myeloma. 4. Patients with any significant medical condition, including active or uncontrolled infection, laboratory abnormalities, or psychiatric illness, that would place them at unacceptable risk of treatment-related complications if participating in the study. 5. Patients who meet one or more of the following laboratory abnormalities: a. Absolute neutrophil count (ANC) 2.5 × upper limit of normal (ULN). f. Total serum bilirubin > 1.5 × ULN, or > 3.0 mg/dL in patients with documented Gilbert’s syndrome. 6. Patients with a diagnosis of malignancy other than multiple myeloma within the past 5 years. Exceptions include adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, prostate cancer not requiring therapy, and adequately resected well-differentiated thyroid cancer. 7. Patients with impaired cardiac function or clinically significant heart disease, including: a. Myocardial infarction within 1 year prior to enrollment, or unstable/uncontrolled disease or condition affecting cardiac function (e.g., unstable angina, New York Heart Association [NYHA] Class III or IV congestive heart failure). b. Uncontrolled cardiac arrhythmia (= Grade 2 per NCI CTCAE v5.0) or clinically significant abnormalities on electrocardiogram (ECG). 8. Positive status for human immunodeficiency virus (HIV), chronic or active hepatitis B, active hepatitis A, or active hepatitis C: a. Known positive HIV status. b. Positive for hepatitis B surface antigen (HBsAg). Patients with resolved infection (i.e., negative HBsAg but positive for anti-HBc and/or anti-HBs) must be screened using real-time PCR for hepatitis B virus (HBV) DNA. Patients with a positive PCR result will be excluded. c. Positive for hepatitis C virus (HCV) antibodies or HCV RNA by PCR, unless sustained virologic response (SVR) has been achieved at least 12 weeks following completion of antiviral therapy. 9. Pregnant or breastfeeding women. 10. Subjects who have already received ixazomib or pomalidomide-containing therapy as a previous treatment 11. Subjects with peripheral neuropathy grade 2 or higher 12. Subjects who are currently taking or plan to take strong CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, St. John’s Wort)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate(ORR) ;Complete response rate(CR);Higher response rate than VGPR;Overall survival(OS);Duration of response(DoR);Time to next treatment;Safety profiles | — |
Countries
Korea, Republic of
Contacts
Public ContactJiSu Park
Pusan National University Hospital
Outcome results
None listed