Clinical trial · Observational
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 Italian ObServational sTudy (MUST)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Relapse Multiple Myeloma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Real-World Overall Response Rate (ORR) for each TCR MM therapy
- timeFrame
- 3-18 months
- description
- 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
- measure
- Real-World Progression Free Survival (PFS)
- timeFrame
- 3-18 months
- description
- The time from initiation of therapy until Progressive Disease (PD) by investigators per IMWG criteria or death due to any cause, whichever occurs first.
- measure
- Real-World Overall Survival (OS)
- timeFrame
- 3-18 months
- description
- Time from initiation of therapy until death due to any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available