None listed
Conditions
Interventions
Drug : 1-8cycle):
-Pomalidomide : 4 mg Oral (D1-D21)
-Bortezomib : 1.3 mg/m² subcutaneous injection (D1, 8, 15, 22)
- Dexamethasone: 40 mg Oral Or IV (D1, 8, 15, 22) (75 20 mg PO or IV)
9cycle~ ):
Sponsors
Chonnam National University Hospital Hwasun Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 20 years at the time of consent. 2. Confirmed diagnosis of multiple myeloma with evidence of disease progression. 3. Relapsed or refractory multiple myeloma after only one prior line of therapy, with documented lenalidomide-refractory disease. Lenalidomide-refractory is defined as disease progression during lenalidomide treatment or within 60 days after the last dose of lenalidomide. 4. Not refractory to bortezomib. If previously treated with a bortezomib-containing regimen, the patient must have achieved at least a partial response during treatment, not have discontinued treatment due to grade =3 bortezomib-related adverse events, and have maintained a response for at least 6 months after the last dose of bortezomib. 5. No prior exposure to pomalidomide. 6. Measurable disease, defined as at least one of the following: -Serum M-protein = 0.5 g/dL -Urine M-protein = 200 mg/24 hr -Abnormal serum free light chain (FLC) ratio with involved FLC – uninvolved FLC difference =10 mg/dL (=100 mg/L) (If serum or urine electrophoresis cannot be measured, an abnormal kappa/lambda ratio must be present: 1.65) 7. Adequate organ function: 1)Liver: Total bilirubin <1.5 × ULN (except in cases of Gilbert’s syndrome); AST/ALT =2 × ULN 2)Renal: Creatinine clearance =20 mL/min or serum creatinine =3.0 mg/dL 3)Bone marrow: ANC =1.0 × 10?/L, Platelets =75 × 10?/L 4)Cardiac: Left ventricular ejection fraction (LVEF) =45% as assessed by echocardiography or MUGA scan 8. Eastern Cooperative Oncology Group (ECOG) performance status =2 9. Provision of written informed consent
Exclusion criteria
Exclusion criteria: 1. History of grade 3–4 peripheral neuropathy (sensory, motor, or autonomic). 2. Presence of = grade 2 peripheral neuropathy at the time of study enrollment despite appropriate treatment. 3. Diagnosis of AL amyloidosis, plasma cell leukemia, POEMS syndrome, or Waldenström’s macroglobulinemia. 4.Uncontrolled, active acute infection requiring systemic antibiotic, antiviral, or antifungal therapy within 2 weeks prior to study drug administration. 5.Evidence of central nervous system involvement by multiple myeloma. 6.Receipt of any anticancer therapy, including radiotherapy or immunotherapy, within 2 weeks prior to study drug administration. 7.Autologous stem cell transplant within 4 weeks or allogeneic stem cell transplant within 12 weeks prior to enrollment. 8.Active graft-versus-host disease (GVHD) requiring systemic treatment in patients with a history of allogeneic stem cell transplant. 9.Major surgery within 4 weeks prior to the first dose of the study drug. 10.History of acute coronary syndrome (e.g., myocardial infarction or unstable angina) within the past 6 months, New York Heart Association (NYHA) Class III–IV heart failure, uncontrolled ventricular arrhythmia, or clinically significant cardiac conduction disorder (e.g., sick sinus syndrome or complete atrioventricular block) without a functioning pacemaker. 11.Known infection with HIV or active hepatitis B or C. (Patients with hepatitis B or C may be enrolled if they are receiving appropriate antiviral therapy.) 12.Severe or uncontrolled medical conditions, abnormal laboratory findings, or psychiatric illness that, in the investigator’s judgment, would make the patient unsuitable for participation in the study. 13.Inability to receive necessary concomitant medications or supportive care due to contraindications. (e.g., hypersensitivity to antiviral agents or inability to tolerate fluid administration due to underlying cardiopulmonary disease) 14.History of any malignancy other than multiple myeloma within the past 3 years, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix or breast, untreated indolent prostate cancer, or completely resected well-differentiated thyroid cancer. 15.Women of childbearing potential or men who have not undergone vasectomy who are unwilling or unable to use medically accepted methods of contraception during the study period. (e.g., partner’s sterilization, intrauterine device, hormonal contraceptives, diaphragm or condom used with spermicide) 16.Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate after therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| (progression free survival; PFS;overall survival; OS;duration of response; DoR;time to next treatment; TTNT;EORTC QLQ-C30 change from baseline;Minimal residual disease negativity | — |
Countries
Korea, Republic of
Contacts
Public ContactJEJUNG LEE
Chonnam National University Hospital Hwasun Hospital
Outcome results
None listed