Understanding treatment for patients with triple class refractory multiple myeloma in Italy
MUltiple Myeloma Italian ObServational sTudy (MUST)
This study is looking to understand how patients with hard-to-treat multiple myeloma are currently being cared for in Italy, including the treatments they receive and the costs involved.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Drugs / interventions | Elranatamab |
| Locations | 1 site (Meldola (FC)) |
| Trial ID | NCT05742217 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on the current clinical practices for treating patients with triple class refractory multiple myeloma (TCR-MM) across approximately 25 centers in Italy. It will analyze the standard of care provided to these patients, including treatment approaches and associated costs. Participants will be adults aged 18 and older who have been diagnosed with multiple myeloma and have not responded to the three main classes of medications used for treatment. Data will be collected from patients who received TCR treatment between December 1, 2021, and May 31, 2022.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed multiple myeloma who are refractory to all three main classes of treatment.
Not a fit: Patients with smoldering multiple myeloma, plasma cell leukemia, amyloidosis, or active graft versus host disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into effective treatment strategies for patients with TCR-MM, potentially improving patient outcomes.
How similar studies have performed: While this study focuses on real-life data collection in Italy, similar studies in other regions have shown success in analyzing treatment approaches for refractory multiple myeloma.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Meldola (FC)
- IRST, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori — Meldola (FC), Italy (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.