NCT06517017招募中2 期
Use of Isatuximab, Dexamethasone and Lenalidomide in a Go-Slow Fashion for Ultra-Frail Patients With Multiple Myeloma: A Phase 2 Multicenter Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Completion rate of 9 cycles of treatment
研究概览
简要总结
Historically, the frailest patients with multiple myeloma are under-represented in clinical trials, and have very high rates of treatment discontinuation, and early treatment mortality. The investigators hypothesize that a go-slow gentle approach to starting treatment in such patients, starting with just Isatuximab and dexamethasone with a gentle introduction to lenalidomide third cycle onwards, may improve treatment adherence and quality of life. The goal of this clinical trial is to learn if a go-slow approach to treating MM in ultra-frail patients may improve the ability to adhere to treatment and improve quality of life.
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
- •Male or female subject aged ≥ 18 years.
- •Histologically confirmed myeloma and/or Plasma Cell Leukemia who are newly diagnosed and having completed ≤ 1 prior cycle of myeloma treatment.
- •For female subjects of childbearing potential: Negative pregnancy test or evidence of post-menopausal status or evidence of permanent surgical sterilization (bilateral oophorectomy or hysterectomy). The post-menopausal status will be defined as having been amenorrheic for 24 months without an alternative medical cause.
- •Subjects must be willing to follow contraception requirements listed in the protocol, agree to participate in the Lenalidomide REMS program, and have signed the Patient-Physician Agreement Form.
- •Male subjects must agree to use a latex condom during intercourse for the duration of study therapy as described in the protocol, even if he has undergone a successful vasectomy.
- •Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy per the treating investigator.
- •Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- •IMWG defined frailty score ≥
- •IMWG definition available here: http://www.myelomafrailtyscorecalculator.net
排除标准
- •Receiving other investigational agents.
- •Any condition that would, in the Investigator's judgment, compromise the subject's ability to understand the subject information, give informed consent, and/or contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [subjects may not receive the drug through a feeding tube], social/ psychological issues, etc.)
- •Known prior severe hypersensitivity (NCI CTCAE v5.0 Grade ≥ 3) to investigational product (IP) or any component in its formulations. This includes hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study intervention that are not amenable to premedication with steroids and H2 blockers or would prohibit further treatment with these agents.
- •Subjects currently taking prohibited medications as described in the protocol.
研究组 & 干预措施
Combination Treatment
Experimental
Isatuximab
干预措施: Isatuximab (Drug)
结局指标
主要结局
Completion rate of 9 cycles of treatment
时间窗: At the end of 9 cycles of treatment (each cycle is 28 days)
Assess the feasibility of approach incorporating the use of isatuximab and dexamethasone with the subsequent addition of lenalidomide from the third cycle onwards in ultra-frail patients with myeloma
次要结局
- Change in quality of life as per the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 domain(At the end of 4 cycles of treatment (each cycle is 28 days))
- Overall survival (OS)(Time from registration until 3 years from start of therapy or death from any cause.)
- Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type(At study completion. Participants will be enrolled in study for about 3 years.)
- Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0)(At study completion. Participants will be enrolled in study for about 3 years.)
- Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness(At study completion. Participants will be enrolled in study for about 3 years.)
- Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration(At study completion. Participants will be enrolled in study for about 3 years.)
- Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment(At study completion. Participants will be enrolled in study for about 3 years.)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
2 期
The REST (Replacing Steroids in the transplant ineligible) study.Multiple myeloma2023-510194-34-00Oslo University Hospital HF51
终止
1 期
Nelfinavir and Lenalidomide/Dexamethasone in Progressive Multiple MyelomaMultiple MyelomaNCT01555281Swiss Group for Clinical Cancer Research33
已完成
2 期
"Monoclonal Antibodies for Treatment of Multiple Myeloma. Emphasis on the CD38 Antibody Daratumumab "Multiple MyelomaNCT02419118Vejle Hospital4
已完成
2 期
VTD Followed By MPT Maintenance As a First Line Treatment For The Patients With MM Who Are Non-Transplant CandidatesMultiple MyelomaNCT00320476Korean Multiple Myeloma Working Party35
已完成
1 期
ECT-001 (UM171) Expanded Cord Blood Transplant to Treat High-risk Multiple MyelomaMultiple MyelomaNCT03441958Ciusss de L'Est de l'Île de Montréal19