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 and a proteasome inhibitor.
- 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.
- Anti-CD38-directed therapy within 6 months preceding the first dose of treatment in this study.
- 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: 

27

Schema di trattamento: 

Experimental: Part 2 Randomized Arm A: Elranatamab
Interventions:
Drug: Elranatamab
Experimental: Part 2 Randomized Arm B: Elranatamab + Daratumumab
Interventions:
Drug: Elranatamab
Drug: Daratumumab
Active Comparator: Part 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone
Interventions:
Drug: Daratumumab
Drug: Pomalidomide
Drug: Dexamethasone
Experimental: Part 3 Randomized Arm D: Alternative Elranatamab dosing + Daratumumab
Interventions:
Drug: Elranatamab
Drug: Daratumumab
Experimental: Part 3 Randomized Arm E: Elranatamab + Daratumumab
Interventions:
Drug: Elranatamab
Drug: Daratumumab.

Trattamento sperimentale: 

Part 2 Randomized Arm A: Elranatamab
Part 2 Randomized Arm B: Elranatamab + Daratumumab
Part 3 Randomized Arm D: Alternative Elranatamab dosing + Daratumumab
Part 3 Randomized Arm E: Elranatamab + Daratumumab

Trattamento di controllo: 

Part 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone

Obiettivi primari dello studio: 

Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria [Time Frame: From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months]
Part 3: Frequency of treatment-emergent adverse events [Time Frame: From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy.]

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-000044-22

Data di inserimento: 02.11.2023

Promotore

Pfizer

CRO

Parexel

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd