Phase I/IIa Study of Belantamab Mafodotin and Venetoclax in Relapsed/Refractory t(11;14) Multiple Myeloma Patients

The primary objective of this study is to evaluate the efficacy and safety of the combination treatment of **Belantamab Mafodotin** and **Venetoclax** in patients with relapsed and refractory t(11;14) **Multiple Myeloma**. This investigation is clinically relevant as it aims to address the therapeutic challenges faced by patients with this specific genetic subtype of Multiple Myeloma, which is often associated with poor prognosis and limited treatment options. The study seeks to determine whether this combination therapy can provide a viable treatment alternative, potentially improving patient outcomes in this difficult-to-treat population.

The clinical trial involves participants diagnosed with **Multiple Myeloma**. The study population includes both male and female subjects, with an age range categorized as adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants. Selection criteria and lifestyle considerations such as diet, physical activity, or habits have not been detailed in the available data.

The clinical trial is designed to evaluate the efficacy and safety of a combination treatment involving **Belantamab Mafodotin** and **Venetoclax** in patients with relapsed and refractory **Multiple Myeloma** characterized by the t(11;14) translocation. This study is structured as a Phase I/IIa trial, with a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The trial is expected to commence recruitment on March 25, 2024, and is projected to conclude by June 30, 2027, providing a comprehensive evaluation period for the investigational treatment.

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 a thorough review of the participant's medical history, physical examination, and necessary laboratory tests. Following successful screening, participants will be randomized into treatment groups and will attend regular follow-up visits to monitor treatment response and safety. These visits will include clinical assessments, laboratory evaluations, and adverse event monitoring. The end-of-study visit will occur after the completion of the treatment period, where final assessments will be conducted to evaluate the overall outcomes of the trial.

The expected duration of participant involvement in the trial will vary depending on individual response to treatment and the specific phase of the trial they are enrolled in. Participants may be withdrawn from the study early if they experience significant adverse effects, fail to comply with study procedures, or if the investigator deems it necessary for their safety. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the well-being of all participants 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 on the treatments used in this clinical trial.

The clinical trial's efficacy assessment details are not explicitly provided in the available data. Information regarding the parameters or endpoints used to evaluate efficacy, such as symptom improvement scores, biomarker levels, or disease remission rates, is not specified. Additionally, the planned methods and schedule for measuring, collecting, and analyzing these efficacy parameters, including any tools or instruments involved, are not mentioned. The trial is categorized under phase 9, with an estimated recruitment start date of March 25, 2024, and an estimated end date of June 30, 2027. Further specifics on efficacy assessment are not available in the provided data.