Phase 3b, Randomized Trial of Revlimid® (Lenalidomide) Versus Placebo Maintenance Therapy Following Melphalan Prednisone Velcade® (Bortezomib) Induction Therapy in Newly Diagnosed Multiple Myeloma - ARUMM

Celgene Corporation0 个研究点目标入组 351 人2014年5月29日

概览

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注册库

who.int

开始日期

2014年5月29日

结束日期

待定

最后更新

5年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•Related to initial diagnosis and prior MPV induction therapy
•1\. Previously untreated and symptomatic multiple myeloma.
•2\. All 3 criteria (Durie, 2003\) and at least one of the CRAB criteria must be met.
•3\. Measurable disease by 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.
•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 cytogenetic (17 p deletion, and 4;14 translocation), ß\-2 microglobulin and serum albumin (ISS Stage) results from their initial diagnosis available at the time of screening.
•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,

•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 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)