KCT0008467Not yet recruitingUnknown
Phase 2 study of selinexor plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma (KMM 2205)
Yonsei University Health System, Severance Hospital0 sites48 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Enrollment
- 48
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20(Year) to o Limit (—)
- Sex
- All
Inclusion Criteria
- •1. Age = 20 years
- •2. Symptomatic multiple myeloma with evidence of disease progression
- •3. Prior treatment with one or two regimens for multiple myeloma (patients who have only one anti-myeloma regimen can be enrolled if the patient was exposed to lenalidomide)
- •4. Not refractory to carfilzomib (those who have previously received carfilzomib-containing therapy can be enrolled if the treatment response has been maintained for more than 6 months after the last dose of carfilzomib administration)
- •5. Have not previously received selinexor
- •6. Measurable lesions
- •- 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 EP or urine EP cannot be determined, serum FLC ratio must be abnormal (Kappa/Lambda ratio < 0.26 or > 1.65))
- •7. Eastern Cooperative Oncology Group (ECOG) performance score: 0-2
- •8. Adequate organ function
- •- hepatic function: total bilirubin < 1.5 x ULN (except Gilbert’s syndrome), AST/ALT = 3 x ULN
- •- renal function: creatinine clearance = 20 mL/min or serum creatinine <3.0 g/dL
- •- hematopoietic function: Absolute Neutrophil Count (ANC) = 1.0 x 109/L, Platelet count = 50 x 109/L (= 30 x 109/L myeloma involvement > 50% on bone marrow examination)
- •9. Life expectancy =3 months
- •10. Written informed consent
Exclusion Criteria
- •1. Non-hematologic toxicity of 3 or 4 due to carfilzomib, if previously treated with carfilzomib
- •2. History of acute coronary syndrome (myocardial infarction, unstable angina), NYHA Class III to IV heart failure, uncontrolled ventricular arrhythmias, and uncontrolled clinically significant cardiac conduction disorder without pacemaker insertion (sick sinus syndrome, complete atrioventricular block, etc.) within 6 months
- •3. Left ventricular ejection fraction < 40% on 2D echocardiography or MUGA scan
- •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, Waldenstrom’s macroglobulinemia
- •6. Central Nervous System (CNS) involvement
- •7. Radiation therapy, chemotherapy, or chemotherapy including immunotherapy within 2 weeks before administration of the study drug
- •8. autologous hematopoietic stem cell transplantation (HSCT) within 4 weeks or allogeneic HSCT within 3 months prior to first dose
- •9. Evidence of ongoing graft-versus-host disease in case of allogeneic HSCT
- •10. Major surgery within 2 weeks prior to first dose
- •11. Acute active infection requiring treatment with systemic antibiotics, antiviral agents, antifungals within 2 weeks prior to first dose
- •12. Known HIV infection, active hepatitis B or C infections (Patients are eligible if they are receiving appropriate antiviral therapy for hepatitis B or C)
- •13. Any other clinically significant or uncontrolled medical conditions, abnormal laboratory results, or psychiatric abnormalities that, in the Investigator’s opinion, may interfere with study participation and protocol adherence
- •14. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs or intolerance to hydration due to preexisting pulmonary or cardiac impairment
- •15. Other malignancy within the past 3 years with the exception of adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix or breast, prostate cancer that does not require treatment, or adequately resected differentiated thyroid cancer.
- •16. Planning to become pregnant during the study period among women of childbearing potential or men who have not had a vasectomy, or one do not agree to follow one of the medically accepted pregnancy avoidance measures (partner’s sterilization, partner’s intrauterine contraceptive device, barrier contraceptive method, combination of diaphragm or condom)
- •17. Pregnant or lactating women
Investigators
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