KCT0003261招募中未知
Randomized Phase 3 study of Pomalidomide-Cyclophosphamide-Dexamethasone (PCD) versus Pomalidomide-Dexamethasone (PD) in relapse or refractory myeloma. An AMN study
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.Multiple myeloma, diagnosed according to standard criteria, with relapsing and refractory disease at study entry
- •2.Patients must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment)
- •a.Serum M-protein = 0.5g/dL, or
- •b.In subjects without detectable serum M-protein, Urine M-protein = 200mg/24 hour, or serum free light chai (sFLC) > 100mg/L (involved light chain) and an abnormal kappa/Lambda ratio
- •3.Can receive up to 6 lines of prior treatment. (Induction therapy followed by stem cell transplantation and consolidation/maintenance therapy will be considered as one line of treatment)
- •4.Must be relapse refractory to prior lenalidomide and bortezomib. Refractoriness is defined as disease progression on treatment or progression within 6 months after the last dose of a given therapy. Relapse is defined according to the criteria of IMWG
- •5.Males and females = 18 years of age or > country’s legal age for adult consent
- •6.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- •7.Patients must meet the following clinical laboratory criteria with 21 days of starting treatment:
- •a.Absolute neutrophil count (ANC) = 1,000/mm3 and platelet = 50,000/mm3 (= 30,000/mm3 if myeloma involvement in the bone marrow is >50%)
- •b.Total bilirubin = 1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x ULN.
- •c.Calculated creatinine clearance = 30mL/min(Patient can still be recruited if calculated creatinine clearance <30ml/min but the dose of pomalidomide will be 3mg per day for 21 days with 1 week rest) or creatinine < 3mg/dL.
- •8.Female patients who:
- •a.Are naturally postmenopausal for at least 2 year before enrolment
- •b.Are surgically sterile
- •c.If they are of childbearing potential**, agree to
- •- adhere to the pomalidomide pregnancy prevention risk management program
- •- All women of childbearing potential must agree to have two negative pregnancy test within 10-14 days and 24hrs before commencing pomalidomide and use two reliable methods of contraception simultaneously or practice complete abstinence from any heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study; 2) while participating in the study; 3) dose interruptions; and 4) for at least 28 days after study treatment discontinuation. The two methods of reliable contraception must include one highly effective method and one additional effective method to prevent pregnancy, not plan on conceiving children during or within 6 months following pomalidomide. (See Appendix 8 Pregnancy Prevention and Risk Management Program)
- •9.Male patients, even if surgically sterilized (i.e. status post-vasectomy), who:
- •a.Agree to practice effective barrier contraception during the entire study treatment period and through 28 days after the last dose of study treatment, OR
- •b.Agree to completely abstain from heterosexual intercourse, AND
- •c.Must also adhere to the guidelines of the pomalidomide pregnancy prevention and risk management program
- •10.Written informed consent in accordance with federal, local and institutional guidelines
排除标准
- •1.Female patients who are lactating or pregnant
- •2.Multiple Myeloma of IgM subtype
- •3.Glucocorticoid therapy (prednisolone > 30mg/day or equivalent) within 14 days prior to informed consent obtained
- •4.POEMS syndrome
- •5.Plasma cell leukemia or circulating plasma cells = 2 x 109/L
- •6.Waldenstrom’s Macroglobulinaemia
- •7.Patients with known amyloidosis
- •8.Chemotherapy with approved or investigation anticancer therapeutics within 21 days prior to starting pomalidomide treatment
- •9.Focal radiation therapy within 7 days prior to start of pomalidomide. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to start of pomalidomide
- •10.Immunotherapy (excluding steroids) 21 days prior to start of pomalidomide
- •11.Major surgery (excluding kyphoplasty) within 28 days prior to start of pomalidomide
- •12.Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischaemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 4 months prior to informed consent obtained
- •13.Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed)
- •14.Patients with known cirrhosis
- •15.Second malignancy within the past 3 years except:
- •a.Adequately treated basal cell or squamous cell skin cancer
- •b.Carcinoma in situ of the cervix
- •c.Breast carcinoma in situ with full surgical resection
- •16.Patients with myelodysplastic syndrome
- •17.Patients with steroid or lenalidomide hypersensitivity
- •18. Prior treatment with pomalidomide
- •19.Ongoing graft-versus-host disease
- •20.Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to starting pomalidomide treatment
- •21.Contraindication to any of the required concomitant drugs or supportive treatments
- •22.Any clinically significant medical disease or psychiatric condition that, in the investigator’s opinion, may interfere with protocol adherence or a patient’s ability to give informed consent.
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