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Not Yet Recruiting NCT05742217

A Study to Learn How Patients With Triple Class Refractory Multiple Myeloma (TCR-MM) Are Treated in Italian Centers for Blood Related Diseases

Conditions: Relapse Multiple Myeloma, Refractory Multiple Myeloma

Sex: All
Ages: 18 Years – N/A
Enrollment: 250
Sponsor: Pfizer

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 olderConfirmed to have MMdo 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.

Eligibility Criteria

Inclusion Criteria:Age ≥18 yearsDiagnosis of MM confirmed using International Myeloma Working Group (IMWG) criteriaPatients are TCR defined as being refractory to all the 3 following classes: at least 1IMiD, at least 1PI and at least 1 anti-CD38 mARelapsed/refractory to last anti-MM regimen prior to first treatment after TCRStarted anti-MM treatment after TCR MM eligibilityEastern 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 documentsExclusion Criteria:Suffering from Smoldering MMSuffering from Plasma cell leukemiaSuffering from amyloidosisSuffering 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 situPatients whose first treatment after becoming TCR was part of a clinical trialParticipation in Elranatamab EAP

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05742217). StuddyBuddy aggregates publicly available trial information.