An Open Label, Multicenter, Phase IV Study of Teclistamab to Evaluate Its Safety in Indian Participants With Relapsed and Refractory Multiple Myeloma Who Have Previously Received at Least 3 Prior Lines of Therapy Including an Immunomodulatory Agent, a Proteasome Inhibitor and an Anti-CD38 Antibody and Have Demonstrated Disease Progression on the Last Therapy
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 24
- 主要终点
- Number of Participants with Treatment-Emergent Adverse Events (TEAE)s
研究概览
简要总结
The purpose of this study is to assess the safety of teclistamab in routine clinical practice when given as monotherapy in Indian participants with relapsed and refractory multiple myeloma (RRMM) (that is, a blood cancer that comes back after treatment or does not respond to treatment) who have previously received at least 3 prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-cluster of differentiation (CD)38 antibody (is a protein that fights infection) and whose disease have progressed on the last therapy.
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
- •Participant with diagnosed RRMM (as per IMWG definitions or investigator's discretion) who have received at least 3 prior lines of therapy including a proteasome inhibitor, an anti-CD 38 antibody and an immunomodulatory agent and have demonstrated disease progression on the last therapy
- •Documented evidence of progressive disease on last line of therapy based on investigator's determination of response by IMWG response criteria
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Contraceptive use by female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and not a woman of child bearing potential (WOCBP) or is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of less than [<] 1 percent [%] per year), preferably with low user dependency, during the treatment period and for a period of 6 months after the last dose of study treatment and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during study period
- •A WOCBP must have a negative highly sensitive serum pregnancy test within 24 hours before the first dose of study treatment
排除标准
- •Participants who are not eligible to receive teclistamab as per the locally approved prescribing information
- •Received any prior B cell maturation antigen (BCMA)-directed therapy
- •Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI, and lumbar cytology are required
- •Stroke, transient ischemic attack, or seizure within 6 months prior to screening
- •Participant had major surgery or had significant traumatic injury within 2 weeks prior to enrollment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study
研究组 & 干预措施
Teclistamab
Participants with RRMM eligible for receiving teclistamab will continue to receive study treatment as per the label.
干预措施: Teclistamab (Drug)
结局指标
主要结局
Number of Participants with Treatment-Emergent Adverse Events (TEAE)s
时间窗: Up to approximately 2 years 1 month
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. TEAEs are AEs with onset during the treatment or that are a consequence of a preexisting condition that has worsened since the first dose of study treatment through the day of last dose plus 30 days or prior to the start of subsequent anticancer therapy, whichever is earlier, or any AE that is considered treatment-related regardless of the start date of the event. TEAEs reported will include all serious and non-serious adverse events.
次要结局
- Overall Response Rate (ORR)(Up to approximately 2 years 1 month)
- Percentage of Participants With Best Response of Very Good Partial Response (VGPR) or Better(Up to approximately 2 years 1 month)