Relapse Multiple MyelomaMUSTNCT05742217
A Study to Learn How Patients With Triple Class Refractory Multiple Myeloma (TCR-MM) Are Treated in Italian Centers for Blood Related Diseases
An observational study of Relapse Multiple Myeloma and Refractory Multiple Myeloma, run by Pfizer at 20 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapse Multiple Myeloma, Refractory Multiple Myeloma
- How many people
- 121 participants
- Where
- 20 sitesItaly
- Study dates
- 26 May 2023to 31 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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:
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
A.O.U. Policlinico S.Orsola Malpighi
Bologna, BO, 40138
A.O.U Policlinico G. Rodolico S. Marco
Catania, Sicily, 95123
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
Clinica di Oncologia Medica Policlinico San Martino
Genova, 16132
IRST, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola (FC), 47014
A.O.U. Policlinico Università degli Studi di Napoli "Federico II"
Naples, 80131
Azienda Ospedaliero-Universitaria Maggiore della Carita
Novara, 28100
A.O.U. Policlinico Paolo Giaccone
Palermo, Sicily, 90129
A.O.O.R. Villa Sofia Cervello, U.O. Oncoematologia
Palermo, Sicily, 90146
Azienda Ospedaliero - Universitaria Di Parma
Parma, 43126
Fondazione IRCCS Policlinico Sa Matteo U.O.C. Ematologia
Pavia, Lombardy, 27100
Ospedale Civile dello Spirito Santo
Pescara, 65124
Arcispedale Santa Maria Nuova
Reggio Emilia, 42123
AUSL della Romagna P.O. Ospedale Infermi U.O. di Oncologia
Rimini, 47923
Irccs Crob
Rionero in Vulture, 85028
AOU Policlinico Umberto I
Rome, Lazio, 00161
San Giovanni Di Dio E Ruggi D'Aragona Hospital
Salerno, 84131
"IRCCS "" Casa Sollievo della Sofferenza""tOpera di San Pio da Pietrelcina U.O.C di Ematologia"
San Giovanni Rotondo, Foggia, 71013
A.O.U. - Ospedali Riuniti di Ancona
Torrette, Aviano, 60126
Busto Arsizio Hospital
Varese, 21052
About this study
Official title: MUltiple Myeloma Italian ObServational sTudy (MUST)
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.
Read more
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.
Read the detailed description
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.
- Keywords
- Multiple Myeloma (MM), Triple Class Refractory (TCR)
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 3-18 months
Real-World Overall Survival (OS)
Time from initiation of therapy until death due to any cause.
Measured: 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.
Measured: 3-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start26 May 2023
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapse Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742217
- Sponsor's protocol ID
- C1071025
- Other IDs
- MUST
- Acronym
- MUST
- Status last verified
- Jul 2026
- First submitted
- 15 Feb 2023
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MUltiple Myeloma Italian ObServational sTudy (MUST)
- ClinicalTrials.gov ID
- NCT05742217
- Acronym / sponsor ID
- MUST / C1071025
- Keywords
- Multiple Myeloma (MM), Triple Class Refractory (TCR)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 26 May 2023 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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:
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapse Multiple Myeloma and Refractory Multiple Myeloma, run by Pfizer at 20 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-World Overall Response Rate (ORR) for each TCR MM therapy (time frame: 3-18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.