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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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)
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-Mail: ClinicalTrials.gov_Inquiries@pfizer.com
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: RETROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Real World Progression Free Survival (rwPFS)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Pfizer CT.gov Call Center, Pfizer
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Neubildungen
- Erkrankungen des Immunsystems
- Neubildungen nach histologischem Typ
- Hämatologische Erkrankungen
- Lymphoproliferative Erkrankungen
- Immunproliferative Erkrankungen
- Hämostasestörungen
- Paraproteinämien
- Bluteiweißstörungen
- Hämorrhagische Störungen
- Hämische und lymphatische Krankheiten
- Multiples Myelom
- Neubildungen, Plasmazelle
- Verwaltung des Gesundheitswesens
- Qualität, Zugang und Bewertung im Gesundheitswesen
- Qualität der Gesundheitsversorgung
- Qualitätsindikatoren, Gesundheitsversorgung
- Sorgfalt
Andere Studien-ID-Nummern
- C1071056
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .