A Study to Learn About a Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma
Comparative Effectiveness of Elranatamab Monotherapy in the MagnetisMM-5 Clinical Trial Versus a Real-World External Control Arm of Patients With Relapsed/Refractory Multiple Myeloma With Prior Treatment of Lenalidomide and Proteasome Inhibitor From the Therapy Monitor Multiple Myeloma Dataset in Germany (BasecaMMp)
This study is to understand how well elranatamab (PF-06863135) may be used for relapsed refractory multiple myeloma (RRMM). Sometimes MM might improve at first, but then gets resistant to the treatment and starts growing again (known as relapsed refractory). This study medicine will be compared with standard-of-care (SOC) therapies used in real-world clinical practice. For people receiving elranatamab, we will use data from the phase 3 clinical trial (MagnetisMM-5). We will also use data from a real-world database, representing the SOC in clinical practice. This study does not seek any participants for enrollment. We will compare the experiences of people receiving elranatamab to people receiving SOC therapies. This way, it will help us to know how well elranatamab can be used for RRMM treatment.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Comparative effectiveness of elranatamab monotherapy in the MagnetisMM-5 clinical trial versus a real-world external control arm of patients with relapsed/refractory multiple myeloma with prior treatment of lenalidomide and proteasome inhibitor from the Therapy Monitor Multiple Myeloma dataset in Germany (BasecaMMp)
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Pfizer CT.gov Call Center
- Numéro de téléphone: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Patients treated with elranatamab will come from the MagnetisMM-5 trial. Patients treated with the standard-of-care therapies will come from electronic health record databases in Germany.
La description
To maximize comparability, the eligibility criteria for the participants from MagnetisMM-5 trial will be applied to patients from the RWD source, as feasible.
Inclusion Criteria:
- Male or Female aged 18 years and older at index date
- Diagnosis of MM
- Measurable disease according to IMWG criteria
- Prior anti-MM therapy (1-3 prior lines of therapy)
- ECOG performance status ≤2
Exclusion Criteria:
- Acute plasma cell leukemia
- Amyloidosis
- Smoldering MM
- Stem cell transplant within 12 weeks of index or active graft versus host disease (GVHD)
- Ongoing Grade 2 or higher peripheral sensory or motor neuropathy.
- Active systemic infection or SARS-CoV-2 viral infection
- Active malignancy within 3 years before index, except for basal cell or squamous cell skin cancer or carcinoma in situ
- Other surgical, medical, or psychiatric conditions including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
- Previous treatment with a BCMA-directed therapy or a CD3-redirecting therapy.
- Anti-CD38-directed therapy within 6 months preceding the first dose of treatment in this study
- Refractory to prior anti-CD38-directed therapy (disease progression while on or within 60 days of the last dose of any anti-CD38-directed therapy or failure to achieve at least MR).
- Previous pomalidomide therapy
- Administration with an investigational drug within 30 days prior to index
- For women of childbearing potential: Pregnancy test positive at screening
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: RETROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Elranatamab
Patients treated with elranatamab from the MagnetisMM-5 trial |
BCMA-CD3 bispecific antibody |
|
Standard of care
Patients treated with standard-of-care therapies from real-world data source |
Standard of Care |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Real World Progression Free Survival (rwPFS)
Délai: From the index date through the end of the study period, approximately 6 months.
|
From the index date through the end of the study period, approximately 6 months.
|
|
Overall Survival (OS)
Délai: From the index date through the end of the study period, approximately 6 months.
|
From the index date through the end of the study period, approximately 6 months.
|
|
Time to next treatment (TTNT)
Délai: From the index date through the end of the study period, approximately 6 months.
|
From the index date through the end of the study period, approximately 6 months.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Pfizer CT.gov Call Center, Pfizer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies vasculaires
- Maladies cardiovasculaires
- Tumeurs
- Maladies du système immunitaire
- Tumeurs par type histologique
- Maladies hématologiques
- Troubles lymphoprolifératifs
- Troubles immunoprolifératifs
- Troubles hémostatiques
- Paraprotéinémies
- Troubles des protéines sanguines
- Troubles hémorragiques
- Maladies hémiques et lymphatiques
- Myélome multiple
- Tumeurs, plasmocyte
- Administration des services de santé
- Qualité des soins de santé, accès et évaluation
- Qualité des soins de santé
- Indicateurs de qualité, soins de santé
- Standard de soins
Autres numéros d'identification d'étude
- C1071056
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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