Observational Study in Patient With Multiple Myeloma Relapse/Refractory Treated With Belantamab Mafotidine on Monotherapy Previously Exposed to at Least One Proteasome Inhibitor, Immunomodulatory Agent, and Anti-CD38 Antibody.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 10
- 主要终点
- Best response or minimal response
研究概览
简要总结
This is a retrospective/prospective observational study evaluating the efficacy and safety of Belantamab Mafotidin as a single agent in patients with Multiple Myeloma Relapse/Refractory (MMRR) treated in clinical pratice under compassionate use
详细描述
Multiple myeloma (MM) is an incurable disease that accounts for 1% of all cancers and 10% of all haematological malignancies, most patients with MM develop resistance to existing therapies at the time of disease recurrence.
Belantamab mafodotin is a new humanized antibody-drug conjugate (IgG1) that is under development for the treatment of MM and has demonstrated a manageable safety profile and positive clinical activity in patients with relapsed or refractory multiple myeloma (MMRR) heavily pretreated.
The objective of this retro-prospective observational study is: to evaluate clinical efficacy as the percentage of patients who have achieved a clinical benefit (minimum or best response), ORR, DoR, PFS, OS; evaluate the safety profile of patients treated with Belantamab Mafodotin as monotherapy in clinical practice.
All patients included in this analysis were treated or are still receiving Belantamab Mafodotin monotherapy under the compassionate use programs (nominal program-NPP and the extended access program-EAP).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Written informed consent may be obtained from the patient or legally authorized representative according to local regulations (patients who have already died may also be included)
- •Histologically or cytologically confirmed diagnosis of MM as defined according to IMWG criteria of 2016 and:
- •patient has undergone stem cells transplantation or is considered ineligible for transplantation, and
- •patient has received at least four therapies
- •patient is refractory to an anti-CD38 antibody (ex., daratumumab) alone or in combination, and to an IMiD (ex., lenalidomide or pomalidomide), and to a proteasome inhibitor (ex. bortezomib, ixazomib or carfilzomib).
- •Male or female equal and/or upper 18 years (at baseline)
- •Performance Status at baseline by ECOG scale 0-2
- •Adequate organ system functions at baseline
- •Female patients: a female patient is elegible if she is not pregnant or breastfeeding and at least one of the following conditions applies:
- •She is/was not a woman of childbearing potential (WOCBP) OR
- •She is/was using an highly effective contrapcetive method during the treatment period and at least 9 months after the last dose and she agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period.
- •Highly sensitive negative serum pregnancy test within 72 hours of therapy (C1D1) and agreed to use effective contraception during the treatment period and for the next 9 months after the last dose of the drug.
- •Male patient: male patient were/are elegible if agreed to follow from the first dose until the last dose of treatment to allow clearance of any altered sperm:
- •abstaining from sperm donation PLUS
- •abstaing from heterosexual relationship in accordance with one's preferred and habitual lifestyle (long-term and persistent abstinent) and agreed/accepted to remain abstinent OR
- •agree/agreed to use contraption as described below: agree to use male condom even though they have/had succesfully vasectomy and female partner uses/used an additional highly effective contraceptive method.
- •All toxicities related to previous treatment (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) were Grade 1 or less at t at the time of treatment initiation within compassionate use programs, except alopecia and neuropathy grade 2.
排除标准
- •The patients are/were not elegible for compassionate use programs (NPP, EAP)
研究组 & 干预措施
Belantamab Mafoditin
MMRR patients included in Named Patient Program and Expanded Access Program
干预措施: Belantamab mafodotin (Drug)
结局指标
主要结局
Best response or minimal response
时间窗: 1 year
percentage of patients that achieved a clinical benefit
次要结局
- Overall Response Rate (ORR)(1 year)
- Duration of Response (DoR)(1 year)
- Progression Free Survival (PFS)(1 year)
- Overall Survival(1 year)