A Study to Learn How Patients With Triple Class Refractory Multiple Myeloma (TCR-MM) Are Treated … (NCT05742217) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study to Learn How Patients With Triple Class Refractory Multiple Myeloma (TCR-MM) Are Treated in Italian Centers for Blood Related Diseases
Italy250 participantsStarted 2023-05-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an observational study tracking how triple class refractory multiple myeloma is actually being treated in Italian blood disease centers rather than testing a new drug, what does that mean for my own treatment options — would being part of this study change what therapies I'm offered?
2This study is no longer enrolling new patients — so if I can't join it, are there other active trials specifically for triple class refractory myeloma that I might be eligible for instead?
3The study is measuring real-world survival and response rates across different TCR-MM therapies used in Italian centers — based on what's already being observed in studies like this, which treatment approach do you think would be the strongest option for my specific situation?
4Triple class refractory myeloma means the cancer has stopped responding to three major drug classes — given how hard that is to treat, should we be prioritizing a standard approved therapy right now, or is there a clinical trial testing something newer that might make more sense for me?
5Since this study is collecting data on how long responses last across different TCR-MM treatments, do you have access to any early findings or similar real-world data that could help us compare the options you're considering for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Real-World Overall Response Rate (ORR) for each TCR MM therapy