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

Launched by PFIZER · Feb 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how patients with a specific type of multiple myeloma, called Triple Class Refractory Multiple Myeloma (TCR-MM), are treated in various blood disease centers in Italy. TCR-MM means that the cancer hasn’t responded to the three main classes of medicines typically used for this condition. The goal of the study is to understand current treatment practices, costs, and the standard care patients are receiving in about 25 hospitals.

To be eligible for the study, patients must be at least 18 years old, have a confirmed diagnosis of multiple myeloma, and have not responded to at least one treatment from each of the three main medication classes. Participants won’t need to attend any extra clinical visits; the study will gather information directly from their medical records. It’s important to note that patients with certain other conditions, like smoldering multiple myeloma or active graft versus host disease, will not be included in this trial.

Gender

ALL

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