Phase II Study of Quadruplet Induction and Consolidation with Tandem Autologous Stem Cell Transplantation in Newly Diagnosed High-Risk Multiple Myeloma

The primary objective of this phase II study is to evaluate the efficacy of an intensive treatment regimen involving **quadruplet induction** and consolidation therapy, followed by tandem **autologous stem cell transplantation** in patients with newly diagnosed high-risk **Multiple Myeloma**. This approach aims to improve patient outcomes by potentially increasing remission rates and prolonging survival in this high-risk population. The study is conducted by the Intergroupe Francophone du Myélome (IFM) under the title "An intensive program with quadruplet induction and consolidation plus tandem autologous stem cell transplantation in Newly Diagnosed High Risk Multiple Myeloma Patients: a phase II study of the Intergroupe Francophone du Myélome (IFM 2018-04)".

The clinical trial involves 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. The trial does not focus on 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 specified. The trial aims to gather data from a diverse group of individuals without targeting any specific vulnerable groups.

The clinical trial is designed to evaluate the efficacy of an intensive treatment regimen in patients with **Multiple Myeloma**. This study is a phase II trial, employing a randomized, double-blind, and controlled methodology to ensure the reliability and validity of the results. The trial commenced on July 25, 2019, and is projected to conclude by March 21, 2028, encompassing a comprehensive duration to adequately assess the treatment outcomes.

Participants will undergo a series of structured study visits, beginning with an inclusion visit, which serves as a screening to determine eligibility based on predefined criteria. Following successful inclusion, participants will engage in multiple follow-up visits, which are strategically scheduled to monitor treatment response, manage any adverse effects, and ensure adherence to the study protocol. The end-of-study visit marks the final assessment, where comprehensive data collection will occur to evaluate the primary and secondary endpoints of the trial.

The expected length of participant involvement spans the entire duration of the trial, contingent upon individual response to treatment and adherence to protocol requirements. Conditions that may lead to early termination from the study include significant adverse reactions, non-compliance with study procedures, or withdrawal of consent by the participant. The trial's design and procedures are meticulously crafted to uphold scientific rigor and ethical standards, ensuring the generation of robust and meaningful data.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

The clinical trial is in Phase 4 and is scheduled to conclude on March 21, 2028. The recruitment for the trial began on July 25, 2019. The efficacy of the intervention will be assessed through parameters that are not specified in the provided data. The trial's design and methodology for measuring, collecting, and analyzing efficacy parameters are not detailed in the available information. The trial's primary and secondary endpoints, as well as the specific tools or instruments used for efficacy assessments, are not mentioned. The trial is categorized under trial category 1, with a trial category ID of 35054.