A Multicenter, Open Label Study Of Oral Revlimid And Prednisone (Rp) Followed By Oral Revlimid Melphalan And Prednisone (Mpr) In Newly Diagnosed Elderly Multiple Myeloma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 主要终点
- RP as induction followed by MPR as consolidation treatment is safe and induce a significant rate of PR (and CR)
研究概览
简要总结
This study will determine whether the association of Revlimid and Prednisone (RP) as induction treatment followed by Revlimid, Melphalan and Prednisone (MPR) as consolidation treatment is safe and induce a significant rate of PR (and CR) in newly diagnosed elderly MM patients.
详细描述
This phase II study is a multicenter, open label trial designed to determine whether the association of Revlimid and Prednisone (RP) as induction treatment followed by Revlimid, Melphalan and Prednisone (MPR) as consolidation treatment is safe and induce a significant rate of PR (and CR) in newly diagnosed elderly MM patients.
This study consists of 3 phases for each study subject: Pre-treatment, Treatment, long-term follow-up (LTFU).
Pre-treatment period: after providing written informed consent, patients will undergo screening for protocol eligibility as outlined in the Schedule of Study Assessments.
Treatment period: includes induction, consolidation and maintenance.
Induction regimen:Patients will start induction treatment with association of Lenalidomide and Prednisone (RP).
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
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 65 years of age or older at the time of signing the informed consent.
- •Patient is, in the investigator(s) opinion willing and able to comply with the protocol requirements.
- •Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- •Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy.
- •Female patient is either post-menopausal for 24 consecutive months or surgically sterilised or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time (one highly effective method and one additional effective method)(Highly Effective Methods: Intrauterine device -IUD-; Hormonal -birth control pills, injections, implants-; tubal ligation; partner's vasectomy; Additional Effective Methods: Latex condom; Diaphragm; Cervical Cap) for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy.
- •Patient was a newly diagnosed multiple myeloma based on standard criteria
- •Patient has measurable disease, defined as follows: - Secretory myeloma: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA M-Protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours; - Non-secretory myeloma: > 30% plasma cells in the bone marrow and at least one plasmacytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e., MRI or CT scan).
- •Patient has a Karnofsky performance status ≥ 50%.
- •Patient has a life-expectancy >3 months.
排除标准
- •Any serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from signing the informed consent form or placed the subjects at unacceptable risk.
- •Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid; < to the equivalent of dexamethasone 40 mg/day for 4 days).
- •Pregnant or lactating females
- •Known positive for HIV or active infectious hepatitis type A, B or C
研究组 & 干预措施
RP followed MPR
干预措施: RP followed by MPR (Drug)
结局指标
主要结局
RP as induction followed by MPR as consolidation treatment is safe and induce a significant rate of PR (and CR)
时间窗: Approximately 24 months
Determine whether the association of RP as induction followed by MPR as consolidation treatment is safe and induce a significant rate of PR (and CR) in elderly patients with newly diagnosed multiple myeloma.
次要结局
- Determine the progression free survival (PFS), overall survival (OS) and whether responses obtained with RP - MPR treatment, are associated with a prolongation of PFS, in comparison with non-responding patients.(Approximately 24 months)