Safety Evaluation of CC-93269 in Patients with Relapsed and Refractory Multiple Myeloma

The primary objective of this clinical trial is to evaluate the **safety** of CC-93269, an antibody, in individuals diagnosed with **relapsed and refractory multiple myeloma (RRMM)**. This condition is characterized by the return of multiple myeloma after a period of treatment and a lack of responsiveness to subsequent therapies. Understanding the safety profile of CC-93269 is clinically significant as it may offer a new therapeutic option for patients with limited treatment alternatives. No secondary objectives are specified for this study.

The clinical trial involves a total of **138 participants** diagnosed with **relapsed and refractory multiple myeloma (RRMM)**. 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 inclusion or exclusion criteria were not provided. The general health status of the participants is characterized by their condition of RRMM. Lifestyle considerations such as diet, physical activity, or habits were not specified in the available data.

The clinical trial is designed to evaluate the safety of **CC-93269**, an antibody, in individuals diagnosed with **relapsed and refractory multiple myeloma (RRMM)**. This study is structured as a Phase 1 trial, which typically involves a small group of participants to assess safety, dosage, and side effects. The trial employs a randomized, double-blind, controlled design to ensure unbiased results and to compare the effects of the investigational product against a control. The estimated duration of the trial spans from April 13, 2018, to April 13, 2028, allowing for comprehensive data collection and analysis over a ten-year period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on specific criteria. This initial visit will involve a thorough assessment of the participant's medical history and current health status. Following successful inclusion, participants will attend regular follow-up visits, which are scheduled to monitor their response to the treatment and to identify any adverse effects. These visits will include various assessments such as physical examinations, laboratory tests, and imaging studies as necessary. The end-of-study visit will mark the conclusion of the participant's involvement, where final evaluations will be conducted to gather comprehensive data on the long-term effects of the treatment.

The expected length of participant involvement in the trial will vary depending on individual response to the treatment and the occurrence of any adverse events. Participants may be subject to early termination from the study if they experience significant adverse reactions, fail to comply with study protocols, or if the investigator deems it necessary for their safety. The trial's design and procedures are meticulously structured to ensure the collection of reliable data while prioritizing participant safety and well-being throughout the study duration.

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 through a structured evaluation process. The trial is categorized as a Phase 1 study, which typically focuses on assessing safety, tolerability, and pharmacokinetics, but may also include preliminary efficacy assessments. The trial is scheduled to run from April 13, 2018, with an estimated end date of April 13, 2028. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, Phase 1 trials often involve the collection of data that could inform future studies on efficacy, such as changes in **biomarker** levels or initial symptom improvement. The methods for measuring and analyzing these parameters are not specified, but they would generally involve validated scales or laboratory tests appropriate for the condition under investigation. The trial's design and execution will adhere to standard clinical trial protocols to ensure the reliability and validity of the collected data.