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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05742217
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Relapse Multiple Myeloma, Refractory Multiple Myeloma
Study Website: View Trial Website
Additional Details

In Italy, MM represents 1.6 percent of all cancers diagnosed in men and 1.5 percent of those diagnosed in women. The 2020 Italian epidemiological data show 5759 new diagnosis of MM. Most MM patients relapse or become refractory to various therapeutic approaches and typically cycle through many lines of treatment. Survival among patients refractory to newer therapies, including PIs, IMiDs and anti-CD38 mAbs, is very low and measured in months. An Italian real life data collection is important to analyse the current therapeutic approaches in TCR patients and the costs incurred by the therapy based on the different treatments.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Meldola (FC), Italy

Status

Recruiting

Address

IRST, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola (FC), , 47014

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