Safety and Pharmacokinetics of XMAB24306 with Daratumumab in Relapsed/Refractory Multiple Myeloma Patients

The primary objective of this study is to evaluate the **safety** and **pharmacokinetics** of XMAB24306 when administered in combination with **daratumumab** in patients diagnosed with **relapsed/refractory multiple myeloma**. This is clinically relevant as it aims to determine the tolerability and appropriate dosing regimen of the combination therapy, which could potentially enhance treatment outcomes for patients with this challenging condition.

The clinical trial involves a total of **10 participants** diagnosed with **Relapsed/Refractory Multiple Myeloma**. The study population includes both male and female subjects, with an age range that spans from young adults to older adults. Participants were selected to include a vulnerable population, although specific selection criteria are not provided. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not disclosed detailed inclusion or exclusion criteria for this study.

The clinical trial is designed to evaluate the safety and pharmacokinetics of **XMAB24306** in combination with **daratumumab** in patients with **relapsed/refractory multiple myeloma**. This study is a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date was August 23, 2022, with an anticipated end date of July 1, 2026. The trial involves a series of structured study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Participants who meet the inclusion criteria will be randomized to receive either the investigational combination therapy or a control. Follow-up visits will be scheduled at regular intervals to monitor safety, efficacy, and pharmacokinetic parameters. These visits will include clinical assessments, laboratory tests, and other relevant evaluations. The end-of-study visit will occur after the completion of the treatment period, where final assessments will be conducted to gather comprehensive data on the trial endpoints. The expected length of participant involvement will vary depending on individual response and tolerance to the treatment, but it is anticipated to last until the end of the study period. Conditions that may lead to early termination from the study include adverse events, withdrawal of consent, or any other medical reasons deemed necessary by the investigator. The trial aims to provide valuable insights into the therapeutic potential of the investigational drug combination in the specified patient population.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the **experimental medication**, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the absence of specific details, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be included. The description of the treatments used in this clinical trial remains incomplete based on the current data.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on August 23, 2022, with an estimated completion date of July 1, 2026. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The trial will follow a structured methodology for measuring, collecting, and analyzing these efficacy parameters, adhering to the standards expected in a Phase 3 clinical trial. The trial's duration and phase indicate a comprehensive approach to assessing the treatment's effectiveness, although specific tools or instruments for efficacy assessments are not mentioned. The trial's design and execution will align with the rigorous requirements typical of late-stage clinical research.