NL-OMON52982已完成3 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 - OP-103
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female, age 18 years or older
- •2. A prior diagnosis of multiple myeloma with documented disease progression
- •requiring further treatment at time of screening
- •3. Measurable disease defined as any of the following:
- •* Serum monoclonal protein >= 0.5 g/dL by protein electrophoresis.
- •* >= 200 mg/24 hours of monoclonal protein in the urine on 24-hour
- •electrophoresis
- •* Serum free light chain >= 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
- •a 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 is defined as progression 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. Eastern Cooperative Oncology Group (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 program. All patients enrolled outside of Canada and the
- •USA must be willing to comply with all the requirements of the pomalidomide 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
- •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 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 transfusions during
- •the 10 days prior to first drug adminis
排除标准
- •1. Primary refractory disease (i.e. never responded (>= MR) to any prior
- •2. Evidence of mucosal or internal bleeding or platelet transfusion refractory
- •(platelet count fails to increase by > 10,000 after a 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 cel 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+).
- •* 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 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-versushost-disease).
- •18. Prior major surgical procedure or radiation therapy within 4 weeks of the
- •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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