Clinical trial NCT05742217: A Study to Learn How Patients With Triple Class Refractory Multiple Myeloma (TCR-MM) Are Treated in Italian Centers for Blood Related Diseases
Official title: MUltiple Myeloma Italian ObServational sTudy (MUST)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Relapse Multiple Myeloma
Refractory Multiple Myeloma
Keywords: Multiple Myeloma (MM)
Triple Class Refractory (TCR)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-02-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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:

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Real-World Overall Response Rate (ORR) for each TCR MM therapy
timeFrame: 3-18 months
measure: Real-World Progression Free Survival (PFS)
timeFrame: 3-18 months
measure: Real-World Overall Survival (OS)
timeFrame: 3-18 months
measure: Real-World Duration of response (DOR)
timeFrame: 3-18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Meldola (FC)
country: Italy
facility: IRST, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: