Evaluation of Safety and Pharmacokinetics of Forimtamig in Patients With Relapsed or Refractory Multiple Myeloma

The primary objective of this study is to evaluate the **safety** and **pharmacokinetics** of escalating doses of Forimtamig in participants with **relapsed or refractory multiple myeloma**. This is clinically relevant as it aims to determine the appropriate dosing regimen and assess potential adverse effects, which are critical for the safe and effective use of Forimtamig in this patient population.

The clinical trial involves a total of **93 participants** diagnosed with **Relapsed or Refractory Multiple Myeloma**. The study population includes both male and female subjects, with an age range encompassing adults and older adults. Participants were selected to include a vulnerable population, although specific selection criteria have not been disclosed by the sponsor. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The general health status of the participants is not detailed, and no additional key inclusion or exclusion criteria have been provided.

The clinical trial is designed to evaluate the **safety** and pharmacokinetics of escalating doses of Forimtamig in participants with **relapsed or refractory multiple myeloma**. This study is structured as a Phase 3, randomized, double-blind, controlled trial. The estimated duration of the trial spans from October 3, 2020, to August 15, 2026. Participants will undergo a series of study visits, beginning with an inclusion visit, which serves as a screening to determine eligibility based on predefined criteria. Following successful inclusion, participants will attend regular follow-up visits to monitor their response to the treatment and assess any adverse effects. The trial will conclude with an end-of-study visit, where final evaluations will be conducted to gather comprehensive data on the treatment's efficacy and safety.

The expected length of participant involvement in the study is contingent upon the individual's response to the treatment and the overall trial timeline. Participants may be subject to early termination from the study if they experience significant adverse effects, fail to comply with study protocols, or if the study is discontinued for any reason. The trial's methodology ensures that data collected is robust and reliable, contributing valuable insights into the treatment of relapsed or refractory multiple myeloma.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its **pharmaceutical form**, dosage, route, or frequency of administration. Additionally, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, that may be used in the study. Furthermore, the documentation lacks details on drug administration, dosing schedules, and participant compliance monitoring. As such, no further description of the treatments used in this clinical trial can be provided based on the available data.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to conclude on August 15, 2026, with recruitment having commenced on October 3, 2020. The efficacy assessment will be conducted using predefined primary and secondary endpoints, although specific endpoints are not detailed in the available data. The trial will follow a structured methodology to ensure the accurate measurement and analysis of efficacy parameters. The study will adhere to rigorous standards typical of Phase 3 trials, ensuring that the data collected is robust and reliable for evaluating the treatment's effectiveness. The trial's design and execution will align with established clinical protocols to provide meaningful insights into the treatment's impact on the targeted medical condition.