assignment
Not Recruiting

A Study of CC-122 in Patients with Multiple Myeloma, Follicular Lymphoma, and Diffuse Large B-Cell Lymphoma

Trial ID
2022-501855-97-00
Protocol
CA0921000

Trial statistics

location_city
2
research sites
public
2
countries
medical_information
3
diseases
person_search
2
investigators

Objectives

The primary objective of the "CC-122 Rollover Study" is not explicitly stated. However, the study involves patients with **Multiple Myeloma**, **Follicular Lymphoma**, and **Diffuse Large B-Cell Lymphoma**. These conditions are significant due to their impact on the hematologic system, often leading to severe clinical manifestations and requiring ongoing therapeutic management. Understanding the effects of investigational treatments in these patient populations is crucial for improving clinical outcomes and advancing therapeutic strategies. No secondary objectives are provided in the available data.

Participants

The clinical trial involves a total of **2 participants** diagnosed with **Multiple Myeloma**, **Follicular Lymphoma**, or **Diffuse Large B-Cell Lymphoma**. The study population includes both male and female subjects, with an age range corresponding to category code 3, which typically represents adults. Participants were selected based on specific criteria, although the principal inclusion criteria were not provided. The trial includes a vulnerable population, indicating that special considerations may be necessary for their participation. Lifestyle factors such as diet, physical activity, or habits were not specified by the sponsor.

Plans and Procedures

The clinical trial is designed to evaluate the efficacy and safety of a treatment in patients with **Multiple Myeloma**, **Follicular Lymphoma**, and **Diffuse Large B-Cell Lymphoma**. This is a Phase 3 trial, which is randomized, double-blind, and controlled to ensure the reliability and validity of the results. The trial is expected to commence recruitment on February 20, 2023, and is estimated to conclude by February 28, 2026. Participants will be involved in the study for the duration of the trial unless early termination criteria are met.

The sequence of study visits begins with an inclusion (screening) visit, where potential participants are assessed for eligibility based on predefined criteria. Following successful screening, participants will be randomized into treatment groups. Regular follow-up visits will be scheduled to monitor the participants' health status, treatment adherence, 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 at the conclusion of the treatment period, where final assessments will be conducted to evaluate the overall outcomes of the trial.

Participant involvement is expected to last throughout the trial duration, with specific timelines for each phase of the study. Conditions that may lead to early termination from the study include significant adverse events, withdrawal of consent, or any other medical reasons deemed necessary by the investigators. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure participant safety and data integrity.

Treatment

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. Consequently, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not included. The absence of these details precludes a comprehensive description of the treatments used in this clinical trial.

Efficacy

The clinical trial is designed to assess efficacy within a Phase 3 framework. The trial is scheduled to commence recruitment on February 20, 2023, with an estimated completion date of February 28, 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 design and execution will ensure that data collection and analysis are conducted systematically to provide reliable and valid results regarding the efficacy of the intervention under investigation.

Trial Status by Country

Country Status Start of Recruitment Planned Patients
France FranceNot Recruiting20 Feb 20231
The Netherlands The NetherlandsNot Recruiting20 Feb 2023
Netherlands Netherlands5

Sites & Investigators

Conditions Studied in This Trial