Dose Optimization and Safety Evaluation of ABBV-383 in Patients with Relapsed or Refractory Multiple Myeloma

The primary objective of this study is to evaluate the **dose optimization measures** and safety of ABBV-383 in subjects with **Relapsed or Refractory Multiple Myeloma**. This is clinically relevant as optimizing the dosage can enhance therapeutic efficacy while minimizing adverse effects, thereby improving patient outcomes in this challenging condition.

The clinical trial involves a total of **53 participants** diagnosed with **Relapsed or Refractory Multiple Myeloma**. The study population includes both male and female subjects, with an age range spanning from adults to the elderly. 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 health status of participants is characterized by their condition of relapsed or refractory multiple myeloma, but further details on general health status are not provided.

The clinical trial is designed to evaluate the **dose optimization** measures and safety of ABBV-383 in subjects with **Relapsed or Refractory Multiple Myeloma**. This study is a Phase 3, randomized, double-blind, controlled trial. The estimated recruitment start date is April 24, 2023, with an anticipated end date of January 31, 2025. The trial will involve multiple 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 product or a control. The trial will include several follow-up visits to monitor safety, efficacy, and any adverse events. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The end-of-study visit will occur after the final dose administration and will include comprehensive assessments to evaluate the overall outcomes of the trial. 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 study's conclusion. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any other medical reasons deemed necessary by the investigator. Participants will be closely monitored throughout the trial to ensure their safety and the integrity of the study data.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

Due to the lack of specific information in the source data, further details about the **experimental medication** and any **non-experimental treatments** cannot be provided. The trial documentation should be consulted for comprehensive information regarding the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on April 24, 2023, with an estimated completion date of January 31, 2025. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are not specified. The trial will adhere to rigorous standards typical of Phase 3 studies, ensuring that the data collected is robust and reliable. The trial's design and execution will follow established protocols to ensure the validity and reliability of the efficacy assessments.