C1071005: An open-label, 3-arm, multicenter, randomized phase 3 study to evaluate the efficacy and safety of Elranatamab (PF-06863135) monotherapy and Elranatamab + Daratumumab versus Daratumumab + Pomalidomide + Dexamethasone in participants with relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (MagnetisMM-5)

Studio Clinico

Patologia: Mieloma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).
- Measurable disease based on IMWG criteria as defined by at least 1 of the following:
   - Serum M-protein ≥0.5 g/dL.
   - Urinary M-protein excretion ≥200 mg/24 hours.
   - Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
- Prior anti-multiple myeloma therapy including treatment with lenalidomide.
- ECOG performance status ≤2.
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
- Not pregnant and willing to use contraception.

Criteri di esclusione: 

- Smoldering multiple myeloma.
- Plasma cell leukemia.
- Amyloidosis.
- POEMS Syndrome.
- Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
- Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
- Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- Previous treatment with a BCMA-directed therapy.
- Live attenuated vaccine within 4 weeks of the first dose of study intervention.
- Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.

Numero di pazienti previsti: 

10

Schema di trattamento: 

Experimental: Part 3 Arm D: Elranatamab subcutaneous
Experimental: Part 3 Arm E: Elranatamab + Daratumumab.
Elranatamab subcutaneous + Daratumumab subcutaneous

Trattamento sperimentale: 

Part 3 Arm D: Elranatamab
Part 3 Randomized Arm E: Elranatamab + Daratumumab

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Part 3: Frequency of treatment-emergent adverse events.

Data di inizio dell'arruolamento: 10.01.2025

Data di fine dell'arruolamento: 30.06.2026

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-000044-22 - 2023-509208-14-00 - NCT05020236

Data di inserimento: 02.11.2023

Data di aggiornamento: 18.12.2025

Promotore

Pfizer

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd