EUCTR2013-001729-26-BE进行中（未招募）1 期
Phase 3b, Randomized Trial of Revlimid® (Lenalidomide) Versus Placebo Maintenance Therapy Following Melphalan Prednisone Velcade® (Bortezomib) Induction Therapy in Newly Diagnosed Multiple Myeloma - ARUMM
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
- 351
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
- •Related to initial diagnosis and prior MPV induction therapy
- •1. Previously untreated and symptomatic multiple myeloma.
- •2. All 3 criteria (Durie, 2003) including and at least one of the CRAB criteria must be met
- •(Appendix K).
- •3. Measurable disease by serum and / or urine protein electrophoresis analyses.
- •4. All subjects must be treated with a minimum of 6 and a maximum of 9 cycles of MPV induction regimen, and must have achieved at least PR as best overall response and maintained at MPV discontinuation. If a subject achieves CR prior to at least 6 cycles, the subject will be eligible, but a minimum of 6 cycles must be administered otherwise. For the MPV approved regimen, please refer to the Velcade® European Public Assessment Report (EPAR), version 07 Jun 2013. Per investigator decision, the following
- •modifications to the EPAR dosing regimen can be accepted:
- •a. Velcade® administration adaptation as long as a minimum of 24 injections and a
- •maximum of 52 injections is given,
- •b. Prednisone can be replaced by Dexamethasone,
- •c. Melphalan can be administered intravenously if dose-intensity is similar to oral
- •5. Subjects must not have received any prior anti-myeloma chemotherapy or any investigational agent except 6-9 cycles of induction therapy with MPV.
- •6.Subjects must have ß-2 microglobulin and serum albumin (ISS Stage) (Appendix L) and cytogenetic (17 p deletion, and 4;14 translocation abnormalities [Appendix O]), results from their initial diagnosis available at the time of screening. However, if the cytogenetic test at initial diagnosis was not performed or the results were inconclusive, the test should be performed at any time before study entry. Any conclusive results from initial diagnosis will be used (Appendix O).
- •Related to the subject
- •7. Must understand and voluntarily sign the informed consent document prior to the conduct of any study related assessments/procedures,
- •8. Age = 65 years: if < 65 years of age, the subject must be non eligible for stem cell transplantation,
- •9. Eastern Cooperative Oncology Group (ECOG) (Appendix G) performance status score
- •10. Able to adhere to the study visit schedules and other protocol requirements,
- •11. Females of Childbearing Potential * (FCBP) must:
- •a. Have two negative pregnancy tests as verified by the study doctor prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy. This applies even if the subject practices true abstinence2 from heterosexual contact (Appendices A-E).
- •b. Either commit to true abstinence † from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study
- •therapy (Appendices A-E).
- •12. Male Subjects must:
- •a. Practice true abstinence † or agree to use a condom during sexual contact with a pregnant female or a FCBP while participating in the study, during dose interruptions and for at least 28 days following IP discontinuation, even if he has undergone a successful vasectomy (Appendices A-E).
- •b. Agree to not donate semen during IP therapy and for 28 days after end of study
- •therapy (Appendices A-E).
- •13. All subjects must:
- •a. Have an understanding that the study medication could have a potential teratogenic risk (Appendices
排除标准
- •The presence of any of the following will exclude the subject from the study enrollment:
- •1. Previous treatment with anti-myeloma therapy other than the required 6-9 cycles of MPV induction therapy (does not include local radiotherapy, bisphosphonates, or a single short course of steroid [ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]).
- •2. Subjects who didn’t achieve PR or better after getting at least 6 cycles of MPV (see the Velcade EPAR, Version 07 Jun 2013) and at the end of MPV whatever the overall response are not eligible.
- •3. Prior therapy with immunomodulating or immunosuppressive agents, or epigenetic or DNA modulating agents. Subjects who received investigational agents are also excluded.
- •4. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- •5. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- •6. Pregnant or lactating females.
- •7. Any of the following laboratory abnormalities:
- •-Absolute neutrophil count (ANC) < 1,000/?L (1.0 x 109/L)
- •-Untransfused platelet count < 50,000 cells/?L (50 x 109/L)
- •-Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
- •-Serum bilirubin levels > 1.5 x ULN
- •8. Renal insufficiency (creatinine clearance [CrCl] < 30 mL/min by Cockcroft-Gault method,Appendix N) or actual CrCl result, or renal failure requiring hemodialysis or peritoneal dialysis.
- •9. Prior history of malignancies , other than multiple myeloma, unless the subject has been
- •free of the disease for = 5 years. Exceptions include the following :
- •a. Basal cell carcinoma of the skin
- •b. Squamous cell carcinoma of the skin
- •c. Carcinoma in situ of the cervix
- •d. Carcinoma in situ of the breast
- •e. Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
- •10. Prior history of deep venous thrombosis (DVT) or pulmonary embolus (PE) within 6months of randomization.
- •11. Subjects who are unable or unwilling to undergo anti-thrombotic therapy.
- •12. Peripheral neuropathy of > Grade 2 severity according to the NCI CTCAE Version 4.0.
- •13. Known Human Immunodeficiency Virus (HIV) positivity or known active infectious hepatitis, type A, B, or C.
- •14. Primary amyloidosis (immunoglobulin light chain) and myeloma complicated by amyloidosis.
- •15. Prior allogeneic or autologous stem cell transplantation.
- •16. Significant active cardiac disease within the previous 6 months including:
- •-New York Heart Association class II-IV congestive heart failure
- •-Unstable angina or angina requiring surgical or medical intervention
- •-Myocardial infarction
- •17. Any condition that confounds the ability to interpret data from the study.
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