Phase 1 Dose-Escalation Study of CC-92328 in Patients with Relapsed/Refractory Multiple Myeloma

The primary objective of this study is to determine the optimal dose of **CC-92328** in subjects with relapsed and/or refractory **multiple myeloma**. This is clinically relevant as identifying the appropriate dosage is crucial for maximizing therapeutic efficacy while minimizing adverse effects in this patient population.

The clinical trial involves a total of **2 participants** diagnosed with **multiple myeloma**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. Participants were selected to include a vulnerable population, although specific criteria for vulnerability are not detailed. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The sponsor has not provided detailed information regarding the main objective of the trial or the principal inclusion criteria.

The clinical trial is a **Phase 1** study designed to evaluate the safety and efficacy of CC-92328 in subjects with **relapsed and/or refractory multiple myeloma**. The trial employs a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The estimated duration of the trial spans from November 1, 2021, to February 10, 2026, encompassing both the recruitment and follow-up phases.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve comprehensive medical evaluations and laboratory tests to confirm the diagnosis of multiple myeloma and determine the suitability for trial participation. Following successful screening, participants will be randomized to receive either the investigational product or a control, with neither the participants nor the investigators aware of the group assignments, maintaining the double-blind nature of the study.

Throughout the trial, participants will attend regular follow-up visits at specified intervals to monitor their health status, assess the treatment's effects, and document any adverse events. These visits will include physical examinations, laboratory tests, and imaging studies as necessary. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to evaluate the overall outcomes and any long-term effects of the treatment.

The expected length of participant involvement will vary depending on individual response to treatment and the occurrence of any adverse events. Conditions that may lead to early termination from the study include significant adverse reactions, disease progression, or withdrawal of consent by the participant. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

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 lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of 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, indicating an early stage of clinical research primarily focused on safety and dosage. The estimated recruitment start date was November 1, 2021, with an anticipated end date of February 10, 2026. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, Phase 1 trials typically involve initial assessments of pharmacokinetics and pharmacodynamics, which may include measuring biomarker levels or other relevant physiological responses. The methods for measuring and analyzing these parameters are not specified, but standard practices in Phase 1 trials often involve laboratory tests and validated scales to ensure accurate and reliable data collection. The trial's efficacy assessments are expected to be conducted at predetermined intervals throughout the study duration, aligning with the trial's objectives and regulatory requirements.