A Study to Learn How Patients With Triple Class Refractory Multiple Myeloma (TCR-MM) Are Treated in Italian Centers for Blood Related Diseases

Multiple myeloma (MM) is a type of cancer of the white blood cells, called plasma cells. These plasma cells help in fighting infections.

TCR-MM is when the cancer does not get treated with the 3 main classes of medicines used to treat this disease.

The purpose of this study is to learn about the present clinical practice in Italy and describe the standard of care that will be given to patients with TCR-MM, and their treatment costs, in around 25 centers who treat patients with blood diseases.

Standard of care (SoC) is the treatment that is accepted as a proper treatment for a certain type of disease and that is widely used by doctors.

The study is seeking for participants who are:

* 18 years of age or older * Confirmed to have MM * do not show any response when treated with the 3 main classes of medicines used to treat MM Data of participants who received the TCR treatment between 01 December 2021 and 31 May will be collected.

The main data source for the study will be the patient medical record. No clinical visits, examinations, or procedures are required as part of this study.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Relapse Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Refractory Multiple Myeloma Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

A.O.U. - Ospedali Riuniti di Ancona, Torrette, Aviano, Italy

About this study

In Italy, MM represents 1.6 percent of all cancers diagnosed in men and 1.5 percent of those diagnosed in women. The 2020 Italian epidemiological data show 5759 new diagnosis of MM. Most MM patients relapse or become refractory to various therapeutic approaches and typically cycle through many lines of treatment. Survival among patients refractory to newer therapies, including PIs, IMiDs and anti-CD38 mAbs, is very low and measured in months. An Italian real life data collection is important to analyse the current therapeutic approaches in TCR patients and the costs incurred by the therapy based on the different treatments.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥18 years
Diagnosis of MM confirmed using International Myeloma Working Group (IMWG) criteria
Patients are TCR defined as being refractory to all the 3 following classes: at least 1IMiD, at least 1PI and at least 1 anti-CD38 mA
Relapsed/refractory to last anti-MM regimen prior to first treatment after TCR
Started anti-MM treatment after TCR MM eligibility
Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (at the date of first dose of first treatment after TCR MM eligibility, or no longer than 6 months prior to this date)
Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Signed Patient informed consent and Privacy consent documents

Exclusion criteria

Suffering from Smoldering MM
Suffering from Plasma cell leukemia
Suffering from amyloidosis
Suffering from active Graft versus host disease (GvHD)
Suffering from any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ
Patients whose first treatment after becoming TCR was part of a clinical trial
Participation in Elranatamab EAP

Treatment and study plan

Primary outcomes

Real-World Overall Response Rate (ORR) for each TCR MM therapy

Time frame: 3-18 months

The proportion of patients with confirmed Stringent Complete Response (sCR), Complete Response (CR), Very good partial response (VGPR), Partial Response (PR) by investigators per the International Myeloma Working Group (IMWG) criteria
Real-World Progression Free Survival (PFS)

Time frame: 3-18 months

The time from initiation of therapy until Progressive Disease (PD) by investigators per IMWG criteria or death due to any cause, whichever occurs first.
Real-World Overall Survival (OS)

Time frame: 3-18 months

Time from initiation of therapy until death due to any cause.
Real-World Duration of response (DOR)

Time frame: 3-18 months

For participants with an objective response (OR) per IMWG criteria, as the time from the first documentation of OR by investigators that is subsequently confirmed, until PD per IMWG criteria, or death due to any cause, whichever occurs first.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

MUltiple Myeloma Italian ObServational sTudy (MUST)

Acronym: MUST

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Feb 23, 2023
Registry last updated: Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed