跳至主要内容
临床试验/NCT06541860
NCT06541860招募中不适用

Salvage Regimens in Multiple Myeloma Patients Double Refractory to Lenalidomide and MoAbs: Evidence From Real World Experience

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
To explore the efficacy and tolerability of different combinations, particularly the PVD regimen, in the emerging context of RRMM after anti-CD38 MoAb plus IMIDS therapy.

研究概览

简要总结

Retrospective and prospective multicenter observational study on patients with relapsed and refractory multiple myeloma after anti-CD38 MoAb therapy and IMIDS treated with onlabel regimens.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with RRMM after therapy with anti-CD38 MoAb plus IMIDS started on therapy with PVD scheme
  • Patients aged ≥ 18 years
  • Patients able to understand and voluntarily sign an informed consent and be willing to consent to the review of clinical data
  • Patients with RRMM after first-line therapy with anti-CD38 MoAb plus IMIDS started on therapy with on-label schemes
  • Patients aged ≥ 18 years
  • Patients able to understand and voluntarily sign an informed consent and be willing to consent to the review of clinical data

排除标准

  • Patients not willing to consent to review of clinical data

结局指标

主要结局

To explore the efficacy and tolerability of different combinations, particularly the PVD regimen, in the emerging context of RRMM after anti-CD38 MoAb plus IMIDS therapy.

时间窗: 2 years

Phase I - Retrospective study The primary objective is to estimate 2-year progression-free survival (PFS) of PVd when used in RRMM after anti-CD38 MoAb and IMIDS Phase II - Prospective study The primary objective is to estimate the 2-year progression-free survival (PFS) of the on-label combinations in patients with relapsed RRMM after first-line therapy with anti-CD38 MoAb plus IMIDS

次要结局

未报告次要终点

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Sponsor

研究点 (1)

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