Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN #07LT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 273
- 试验地点
- 42
- 主要终点
- Percentage of Participants With Progression-free Survival (PFS)
研究概览
简要总结
This study is designed to compare long-term outcomes among patients randomized on the BMT CTN 0702 protocol (NCT01109004), "A Trial of Single Autologous Transplant with or without Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for Patients with Multiple Myeloma". It is hypothesized that use of novel anti-myeloma agents will improve long-term progression-free survival (PFS) after high-dose melphalan followed by autologous hematopoietic cell transplantation (HCT) as compared to a second autologous transplantation.
详细描述
This study is designed to compare long-term outcomes among patients randomized on the BMT CTN 0702 protocol (NCT01109004). All patients who consent will be followed for death, progression, Second Primary Malignancies (SPMs), and Quality of Life (QOL). Patients who do not consent to the long-term follow-up mechanism or who have experienced progression on the BMT CTN 0702 study will be followed through the standard Center for International Blood and Marrow Transplant Research (CIBMTR) long-term follow-up mechanism. Additionally, patients who are eligible and are willing to continue with lenalidomide as maintenance therapy will be provided lenalidomide free of charge. These patients will continue to receive lenalidomide as maintenance therapy until disease progression or discontinuation due to toxicity, death, or withdrawal from the study. The endpoints assessed will include progression-free survival (PFS), overall survival (OS), event-free survival (EFS), incidence of second primary malignancies (SPM) and health quality of life (QOL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data as part of this study:
- •Enrolled and randomized on the BMT CTN 0702 protocol.
- •Alive at the completion of BMT CTN 0702 protocol specified follow-up defined as 4 years post-randomization.
- •Patients without evidence of disease progression at the completion of BMT CTN 0702 protocol specified follow up.
- •Signed Informed Consent Form.
- •Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.
- •Inclusion Criteria for Optional Long-term Lenalidomide Maintenance Therapy:
- •Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data AND receive long-term lenalidomide maintenance therapy as part of this study:
- •Enrolled and randomized to BMT CTN
- •Completion of 3 years of maintenance therapy on BMT CTN
- •Registered in the mandatory Revlimid REMS® program (formerly the RevAssist® for Study Participants (RASP) program), and be willing and able to comply with the requirements of the Revlimid REMS® program, including counseling, pregnancy testing, and phone surveys.
- •Signed informed consent form.
- •Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.
排除标准
- •Patients who meet any of the following criteria will be ineligible to receive long-term lenalidomide maintenance therapy as part of this study:
- •Patients who have evidence of disease progression prior to enrollment.
- •Patients who were discontinued from BMT CTN 0702 lenalidomide maintenance therapy, for any reason, prior to the completion of the 3 years of 0702 maintenance.
- •Female patients who are pregnant (positive - Beta Human Chorionic Gonadotropin) or breastfeeding.
- •Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques during the length of lenalidomide maintenance therapy.
- •Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide.
- •Patients unwilling to take Deep Vein Thrombosis (DVT) prophylaxis.
- •Patients who developed a second primary malignancy, excluding non-melanoma skin cancers after initiation of lenalidomide maintenance therapy on BMT CTN 0702.
研究组 & 干预措施
RVD Consolidation
Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance
干预措施: Lenalidomide (Drug)
Lenalidomide Maintenance
Initial autologous transplant followed by lenalidomide maintenance
干预措施: Lenalidomide (Drug)
Tandem Auto Transplant
Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Percentage of Participants With Progression-free Survival (PFS)
时间窗: 5 years post-randomization in BMT CTN 0702
This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Progression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate progression-free survival during the 5 year post-randomization follow-up period.
次要结局
- Percentage of Participants With Overall Survival (OS)(5 years post-randomization in BMT CTN 0702)
- Percentage of Participants With Secondary Primary Malignancies (SPM)(5 years post-randomization in BMT CTN 0702)
- Percentage of Participants With Disease Progression(5 years post-randomization in BMT CTN 0702)
- Percentage of Participants With Event-free Survival (EFS)(5 years post-randomization in BMT CTN 0702)