A Multi-center, Open-label Extended Access Program of Lenalidomide Plus Low-dose Dexamethasone in Chinese Subjects With Relapsed/Refactory Multiple Myeloma Who Participated in Study CC-5013-MM-021 for at Least One Year.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 65
- 试验地点
- 10
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
CC5013-MM024 is a multicenter, open-label, Extended Access Program (EAP) of lenalidomide plus low dose dexamethasone regimen in Chinese subjects with relapsed or refractory MM who participated in Study CC-5013-MM-021. For subjects who remained progression free under Rd treatment of Study CC-5013-MM-02 1, this LAP offers the option to continue lenalidomide treatment for subjects who have shown therapeutic benefit.
详细描述
After subjects who are still on treatment have completed at least 1 year of therapy in Study CC-5013-MM-021 (from the start date of lenalidomide treatment), the EAP will allow consented subjects who (1) have remained progression free under Rd treatment in Study CC-SO I3-MM-02 I to roll over to the Treatment Phase of the LAP to continue Rd treatment, and (2) have discontinued Rd therapy and are currently in the Long-Term Follow-up Phase in Study CC-5013-MM-021 to roll over to the Safety Follow-up Phase of the EAP for survival and SPM outcomes. The maximum duration of this LAP program is at least 5 years from the time the last on-study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who discontinued treatment but remained for long-term follow-up in the CC-5013-MM-021 study are required to sign an informed consent document (ICD) to roll over to the Safety Follow-up Phase of the Extended Access Program (EAP). These subjects do not require screening for eligibility but must agree to be followed for survival and Second Primary Malignancy (SPM) at a minimum of every 4 months (± 7 days) intervals for at least 5 years from the time the last on-study subject enrolled in Study CC-5013-MM-
- •Subjects who are consented for the Treatment Phase of the EAP must meet the following criteria to continue the same therapy as they received in the Study CC-5013-MM-021:
- •Completed at least 1year of lenalidomide plus low-dose dexamethasone (Rd) treatment and remained progression free under Rd treatment in Study CC-5013-MM-021 at the time of screening visit of this EAP.
- •Able to adhere study visit schedule, compliance with study drug and other protocol requirements in Study CC-5013-MM-
- •Consented to the EAP protocol.
- •Must agree to comply with all Pregnancy Prevention requirements.
- •Females of childbearing potential (FCBP)1:
- •Must agree to use, and be able to comply with, at least 2 forms of reliable contraception simultaneously or to practice complete abstinence from heterosexual intercourse without interruption, from transferring/rolling over from the CC-5013-MM-021 study, at the screening visit for eligibility, throughout study drug therapy (including dose interruptions) and for 28 days after the end of study drug therapy, even if she has amenorrhea. This applies even if the subject practices complete and continued abstinence confirmed on a monthly basis.
- •Must agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 IU/mL (i.e., negative pregnancy test) at screening for eligibility and then every 28 days while on study. For any FCBP, pregnancy testing must continue at the same frequency as during the MM-021 study. If regular or no menstrual cycles, she must agree to ongoing pregnancy testing during the course of the study (every 28 days), during dose interruptions, at study discontinuation and 28 days following study drug discontinuation. If menstrual cycles are irregular, pregnancy testing must occur every 14 days while on study, at study discontinuation and at 14 and 28 days following study drug discontinuation. This requirement also applies to females of childbearing potential who practice complete and continued sexual abstinence.
- •Must agree not to breastfeed during study drug therapy and for at least 28 days following study drug discontinuation.
- •Male subjects:
- •Must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and at least 28 days following study drug discontinuation.
- •Must agree to not donate semen or sperm during study drug therapy and for at least 28 days following study drug discontinuation.
- •Subjects who have a positive finding of pregnancy testing at screening will not be eligible for the Treatment Phase of the EAP but will be consented for the Safety Follow-up Phase in the EAP.
排除标准
- •Subjects will not continue treatment at the discretion of the physician if any of the following criteria occurred during treatment in the CC-5013-MM-021 study or during the Screening Phase.
- •All subjects that are not eligible to continue treatment will enter the Safety Follow-up Phase:
- •Serious hypersensitivity or anaphylaxis to lenalidomide or dexamethasone.
- •Serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document.
- •Any other condition, including the presence of serious laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •Previously discontinued lenalidomide treatment due to toxicity.
- •Newly diagnosed malignancy other than Multiple Myeloma (MM), except the following:
- •Basal cell carcinoma of the skin
- •Squamous cell carcinoma of the skin
- •Carcinoma in situ of the cervix
- •Carcinoma in situ of the breast
- •Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system) or prostate cancer that is curative
研究组 & 干预措施
Lenalidomide and dexamethasone
Cycle 1: 25 mg oral lenalidomide once daily on Days 1-21 every 28 Days and 40 mg oral dexamethasone on Days 8, 15, and 22. Cycle 2 and beyond: 25 oral lenalidomide once daily on Days 1-21 every 28 days and 40 mg oral dexamethasone once daily on Days 1, 8, 15, and 22.
The starting doses of Rd regimen will be the same last doses that the subjects received in Study CC-5013-MM-021, unless event(s) that require dose adjustments (dose modifications, reductions and interruptions) per protocol occurred prior to roll-over.
干预措施: Dexamethasone (Drug)
Lenalidomide and dexamethasone
Cycle 1: 25 mg oral lenalidomide once daily on Days 1-21 every 28 Days and 40 mg oral dexamethasone on Days 8, 15, and 22. Cycle 2 and beyond: 25 oral lenalidomide once daily on Days 1-21 every 28 days and 40 mg oral dexamethasone once daily on Days 1, 8, 15, and 22.
The starting doses of Rd regimen will be the same last doses that the subjects received in Study CC-5013-MM-021, unless event(s) that require dose adjustments (dose modifications, reductions and interruptions) per protocol occurred prior to roll-over.
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Adverse Events (AEs)
时间窗: approximately 4 years
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. A diagnosis or syndrome should be recorded on the AE page of the electronic case report form (eCRF) rather than the individual signs or symptoms of the diagnosis or syndrome. An overdose, accidental or intentional, whether or not it is associated with an AE, or abuse, withdrawal, sensitivity or toxicity to an investigational product should be reported as an AE. If an overdose is associated with an AE, the overdose and adverse event should be reported as separate terms.
次要结局
- Progression Free Survival (PFS(approximately 4 years)
- Time to Progression (TTP)(approximately 4 years)
- Overall Survival (OS)(approximately 4 years)