A Phase III Non-Inferiority Randomized Controlled Trial of Fixed Duration Versus Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 570
- 试验地点
- 48
- 主要终点
- Progression-Free Survival
研究概览
简要总结
Currently, daratumumab or isatuximab are given continuously (non-stop), along side lenalidomide, and dexamethasone as part of multiple myeloma treatment. are given continuously (non-stop). Recent observations suggest that stopping daratumumab or isatuximb after about a year and a half of treatment may work just as well as giving them continuously with lenalidomide and dexamethasone. Sometimes, bortezomib is also given. This study is being done to answer the question: is less daratumumab or isatuximab treatment as good as more?
详细描述
The usual approach for people with myeloma who are not having a stem cell transplant is treatment with daratumumab or isatuximab in combination with lenalidomide, and dexamethasone. These drugs are given continuously until they are no longer effective or cause major side effects.
Those that decide to take part in this study, will be randomly placed in one of two groups. If in the usual care group, patients will continue all the myeloma medicines currently being taken. If in the experimental group, patients will stop the daratumumab or isatuximab injection, and continue taking the myeloma tablets currently being taken. Regardless of which group, patients will stay on treatment indefinitely as long they are benefiting from it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Participants with newly diagnosed multiple myeloma that are transplant-ineligible
- •Measurable disease at the time of diagnosis, as defined by at least one of the following criteria: Serum monoclonal protein (M-protein) ≥ 5 g/L; Urine M-protein ≥ 200 mg/24 hours; Involved serum free light chain measurement ≥ 100 mg/L, provided serum FLC ration is abnormal; For IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin ≥ 750 mg/dL
- •Completed 18-20 cycles of daratumumab-lenalidomide-dexamethasone or isatuximab-lenalidomide-dexamethasone.
- •Obtained at least a partial response per the standard 2016 IMWG criteria
- •ECOG performance status 0-3
- •Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in English, French, or a provided validated language.
- •Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
- •Participants must be accessible for treatment and follow-up.
- •In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrollment.
- •Participants of childbearing potential must have agreed to use a highly effective contraceptive method.
排除标准
- •Known history of concurrent amyloid light chain amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), and Waldenstrom's macroglobulinemia.
- •Patients receiving concurrent treatment with other anti-cancer therapy that would impact the ability to comply with protocol treatment are ineligible. Note: Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of protocol treatment are eligible for this trial
- •Active, uncontrolled bacterial, fungal, or viral infection within 7 days prior to enrollment.
- •Known human immunodeficiency virus (HIV) with CD4 count < 350 cells/microliter. Note that patients who are HIV positive are eligible, provided:
- •They are under treatment with antiretroviral therapy for at least 4 weeks prior to enrollment, with acceptable pharmacokinetic interactions and minimal overlapping toxicity with protocol therapy AND
- •HIV viral load must be < 400 copies/ml within 16 weeks prior to enrollment AND
- •No history of opportunistic infections within the past year.
研究组 & 干预措施
Daratumumab, Lenalidomide, Dexamethasone & Isatuximab
Standard of Care
干预措施: Dexamethasone (Drug)
Daratumumab, Lenalidomide, Dexamethasone & Isatuximab
Standard of Care
干预措施: Daratumumab (Drug)
Daratumumab, Lenalidomide, Dexamethasone & Isatuximab
Standard of Care
干预措施: Lenalidomide (Drug)
Lenalidomide & Dexamethasone
干预措施: Lenalidomide (Drug)
Lenalidomide & Dexamethasone
干预措施: Dexamethasone (Drug)
Daratumumab, Lenalidomide, Dexamethasone & Isatuximab
Standard of Care
干预措施: Isatuximab (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: 9.1 years
PFS is defined as the time from date of enrollment to date of first documentation of disease progression
次要结局
- Overall Survival(9.1 years)
- Partial Response or Better as assessed by IMWG Criteria(9.1 years)
- Incidence of Treatment-Related Grade 3-5 Adverse Events and all infections based on CTCAE 5.0(9.1 years)
- Time to Next Treatment(9.1 years)
- Post-protocol Therapy Documentation checklist(9.1 years)
- Quality of Life Utilizing EORTC QLQ-C30(9.1 years)
- Quality of Life Utilizing FACIT-COST(9.1 years)
- Health Economic Analyses Utilizing EQ-5D-5L(9.1 years)