Lenalidomide (Revlimid®), Adriamycin and Dexamethasone (RAD)as an Induction Therapy in Newly Diagnosed Multiple Myeloma Followed by a Risk-Defined Transplant Strategy and Lenalidomide Maintenance - A Multicenter Phase II Trial by Deutsche Studiengruppe Multiples Myeloma (DSMM XII)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 12
- 主要终点
- Response rate to RAD induction and transplant (stringent CR, CR, very good PR)
研究概览
简要总结
Subjects up to the age of 65 years with newly diagnosed multiple myeloma requiring treatment are eligible. Minimal pretreatment (2 cycles of chemotherapy; local irradiation; surgery) is permitted. After enrollment, patients are to receive four cycles of RAD induction treatment: a combination of lenalidomide (Revlimid), adriamycin, and dexamethasone. If at least a minimal response is achieved to RAD, they will undergo chemomobilization (cyclophosphamide, etoposide) of peripheral blood stem cells and one uniform cycle of high-dose melphalan chemotherapy followed by a first stem cell transplant. If any of the high-risk features (such as elevated beta 2-microglobulin, adverse cytogenetic factors, elevated LDH, Ig A isotype) were present at diagnosis, patients will be allocated to a consolidative allogeneic transplant following dose-reduced conditioning. If no appropriate donor is available, the patient does not consent or lacks of high-risk features a second autograft following high-dose melphalan will be delivered. All patients will proceed to lenalidomide maintenance (one year) following hematopoietic reconstitution.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Newly diagnosed multiple myeloma
- •Maximum of one prior systemic therapy (2 cycles)
- •Presence of CRAB criteria
- •Measurable disease parameters
- •Left ventricular ejection fraction at least 55%
- •DLCO of at least 60%
- •Adequate bone marrow function
- •Use of adequate contraception for female subjects with childbearing potential and all male subjects
- •Eligible for autologous and allogeneic stem cell transplantation
- •Bone marrow baseline sample evaluable for interphase cytogenetics
排除标准
- •Any serious medical conditions preventing the subject from written informed consent
- •Progressive disease (PD) to any initial treatment
- •Pregnant or lactating females
- •Any condition, including the presence of 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
- •Use of any other experimental drug or therapy within 28 days of baseline
- •Preexisting neuropathy of ≥ grade 2 severity
- •Known hypersensitivity to thalidomide
- •Any prior use of lenalidomide
- •Positive for HIV or infectious hepatitis, type A, B or C after serologic testing
- •Serum creatinine despite induction therapy ≥ 2.0 mg/dL
研究组 & 干预措施
Allogeneic stem cell transplant
Second scheduled transplantation performed from an HLA-matched MRD or MUD after conditioning with treosulfan and fludarabine
干预措施: allogeneic stem cell transplant versus second autologous transplantation (Procedure)
Allogeneic stem cell transplant
Second scheduled transplantation performed from an HLA-matched MRD or MUD after conditioning with treosulfan and fludarabine
干预措施: RAD (Drug)
High-dose melphalan chemotherapy
Second high-dose melphalan therapy followed by transplantation of peripheral blood stem cells
干预措施: allogeneic stem cell transplant versus second autologous transplantation (Procedure)
High-dose melphalan chemotherapy
Second high-dose melphalan therapy followed by transplantation of peripheral blood stem cells
干预措施: RAD (Drug)
结局指标
主要结局
Response rate to RAD induction and transplant (stringent CR, CR, very good PR)
时间窗: 9 months from start of treatment
次要结局
- Progression-free survival (PFS)(9 months from start of treatment)
- Incidence and relationship of severe adverse events(1 year from start of treatment)