A Study to Learn How Patients With Triple Class Refractory Multiple Myeloma (TCR-MM) Are Treated in Italian Centers for Blood Related Diseases
MUST
MUltiple Myeloma Italian ObServational sTudy (MUST)
2 other identifiers
observational
250
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2023
CompletedFirst Posted
Study publicly available on registry
February 23, 2023
CompletedStudy Start
First participant enrolled
May 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
May 5, 2026
May 1, 2026
3 years
February 15, 2023
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Real-World Overall Response Rate (ORR) for each TCR MM therapy
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
3-18 months
Real-World Progression Free Survival (PFS)
The time from initiation of therapy until Progressive Disease (PD) by investigators per IMWG criteria or death due to any cause, whichever occurs first.
3-18 months
Real-World Overall Survival (OS)
Time from initiation of therapy until death due to any cause.
3-18 months
Real-World Duration of response (DOR)
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.
3-18 months
Eligibility Criteria
Patients must have evidence of the following criteria in their medical records at the date of first dose of first treatment after TCR MM eligibility to be included in this study:
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (19)
A.O.U. - Ospedali Riuniti di Ancona
Torrette, Aviano, 60126, Italy
A.O.U. Policlinico S.Orsola Malpighi
Bologna, BO, 40138, Italy
"IRCCS "" Casa Sollievo della Sofferenza""tOpera di San Pio da Pietrelcina U.O.C di Ematologia"
San Giovanni Rotondo, Foggia, 71013, Italy
AOU Policlinico Umberto I
Rome, Lazio, 00161, Italy
Fondazione IRCCS Policlinico Sa Matteo U.O.C. Ematologia
Pavia, Lombardy, 27100, Italy
A.O.U Policlinico G. Rodolico S. Marco
Catania, Sicily, 95123, Italy
A.O.U. Policlinico Paolo Giaccone
Palermo, Sicily, 90129, Italy
A.O.O.R. Villa Sofia Cervello, U.O. Oncoematologia
Palermo, Sicily, 90146, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
IRST, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola (FC), 47014, Italy
A.O.U. Policlinico Università degli Studi di Napoli "Federico II"
Naples, 80131, Italy
Azienda Ospedaliero-Universitaria Maggiore della Carita
Novara, 28100, Italy
Azienda Ospedaliero - Universitaria Di Parma
Parma, 43126, Italy
Ospedale Civile dello Spirito Santo
Pescara, 65124, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, 42123, Italy
AUSL della Romagna P.O. Ospedale Infermi U.O. di Oncologia
Rimini, 47923, Italy
Irccs Crob
Rionero in Vulture, 85028, Italy
San Giovanni Di Dio E Ruggi D'Aragona Hospital
Salerno, 84131, Italy
Busto Arsizio Hospital
Varese, 21052, Italy
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2023
First Posted
February 23, 2023
Study Start
May 26, 2023
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.