EUCTR2016-003517-95-AT进行中（未招募）1 期
A Randomized, Controlled, Open-Label, Phase 3 Study of Melflufen/ Dexamethasone Compared with Pomalidomide/Dexamethasone for Patients with Relapsed Refractory Multiple Myeloma who are Refractory to Lenalidomide
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female, age 18 years or older
- •2. A prior diagnosis of multiple myeloma with documented disease progression in need of treatment at time of screening.
- •3. Measurable disease defined as any of the following:
- •? Serum monoclonal protein = 0.5 g/dL by serum protein electrophoresis (SPEP)
- •? = 200 mg/24 hours of monoclonal protein in the urine on 24-hour urine electrophoresis (UPEP)
- •? Serum free light chain (SFLC) = 10 mg/dL AND abnormal serum kappa to lambda free light chain ratio
- •4. Received 2-4 prior lines of therapy (Appendix D), including lenalidomide and proteasome inhibitor (PI), either sequential or in the same line, and is refractory (relapsed and refractory or refractory) to both the last line of therapy and to lenalidomide (= 10 mg) administered within 18 months prior to randomization. Refractory to lenalidomide includes patients who relapsed while on lenalidomide therapy or within 60 days of last dose following at least 2 cycles of lenalidomide with at least 14 doses of lenalidomide per cycle.
- •5. Life expectancy of = 6 months
- •6. ECOG performance status = 2. (Patients with lower performance status based solely on bone pain secondary to multiple myeloma may be eligible following consultation and approval of the medical monitor) (Appendix A)
- •7. Females of child bearing potential (FCBP)* must have a medically supervised negative serum or urine pregnancy test with a sensitivity according to local Risk Evaluation and Mitigation Strategy™ (REMS) or pomalidomide pregnancy prevention plan (PPP) completed within 10 to 14 days prior to planned start of treatment. All FCBP must agree to either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking treatment and as appropriate based on the treatment assignment (See Section 7.7.1). FCBP must also agree to ongoing pregnancy testing. Men must agree to use a condom during sexual contact with a FCBP even if they have had a vasectomy from the time of starting study treatment
- •through 3 months after the last dose of melflufen (Arm A) or 28 days after the last dose of pomalidomide (Arm B). All patients enrolled in Canada and the USA must be willing to comply with all requirements of the Canadian or USA pomalidomide REMS. All patients enrolled outside of Canada and the USA must be willing to comply with all requirements of the PPP (Appendix J). (Willingness, to comply with the REMS or PPP, must be documented prior to knowledge of randomization but is only required if randomized to Arm B).
- •8. Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
- •9. 12-lead Electrocardiogram (ECG) with QT interval calculated by Fridericia Formula (QTcF) interval of = 470 msec (Appendix H).
- •10. The following laboratory results must be met during screening (within 21 days) and also immediately before study drug administration on Cycle 1 Day 1:
- •? Absolute neutrophil count (ANC) = 1,000 cells/mm3 (1.0 x 109/L) (Growth factors cannot be used within 10 days prior to first drug administration)
- •? Platelet count = 75,000 cells/mm3 (75 x 109/L) (without required transfusions during the 10 days prior to first drug administration)
- •? Hemoglobin = 8.0 g/dl (red blood cell (RBC) transfusions are permitted)
- •? Total Bilirubin = 1.5 x upper limit of normal (ULN), or patients diagnosed w
排除标准
- •1. Primary refractory disease (i.e. never responded with = MR to any prior therapy)
- •2. Evidence of mucosal or internal bleeding and/or are platelet transfusion refractory (i.e. platelet count fails to increase by > 10,000 cells/mm3 after transfusion of an appropriate dose of platelets)
- •3. Any medical conditions that, in the Investigator’s opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study. Examples of such conditions are: a significant history of cardiovascular disease (e.g., myocardial infarction, significant conduction system abnormalities, uncontrolled hypertension, = grade 3 thromboembolic event in the last 6 months)
- •4. Prior exposure to pomalidomide
- •5. Known intolerance to IMiDs. (= Grade 3 hypersensitivity reaction or at the investigators discretion)
- •6. Known active infection requiring parenteral or oral anti-infective treatment within 14 days of randomization
- •7. Other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance
- •8. Pregnant or breast-feeding females
- •9. Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluation
- •10. Known human immunodeficiency virus or active hepatitis C viral infection.
- •11. Active hepatitis B viral infection (defined as HBsAg+) are excluded.
- •? Patients with prior hepatitis B vaccine are permitted (defined as HBsAg-, Anti-HBs+, Anti-HBc-).
- •? Non-active hepatitis B (HBsAg-, Anti-HBs+, Anti-HBc+) may be enrolled at the discretion of the investigator after consideration of risk of reactivation.
- •12. Concurrent symptomatic amyloidosis or plasma cell leukemia
- •13. POEMS syndrome [plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes]
- •14. Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within 3 weeks (6 weeks for nitrosoureas) prior to randomization. The use of live vaccines within 30 days before randomization. IMiDs, PIs or corticosteroids within 2 weeks prior to randomization. Other investigational therapies and monoclonal antibodies within 4 weeks of randomization. Prednisone up to but no more than 10 mg orally q.d. or its equivalent for symptom management of comorbid conditions is permitted but dose should be stable for at least 7 days prior to randomization.
- •15. Residual side effects to previous therapy > grade 1 prior to randomization (Alopecia any grade and/or neuropathy grade 2 without pain are permitted)
- •16. Prior peripheral stem cell transplant within 12 weeks of randomization
- •17. Prior allogeneic stem cell transplantation with active graft-versus-host- disease.
- •18. Prior major surgical procedure or radiation therapy within 4 weeks of randomization (this does not include limited course of radiation used for management of bone pain within 7 days of randomization).
- •19. Known intolerance to steroid therapy
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