C1071007 - A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION (MagnetisMM-7).

Studio Clinico

Patologia: Mieloma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis
- Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive
- History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant.  Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.
- Partial Response or better according to IMWG criteria at the time of randomization
- Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.
- ECOG performance status ≤1
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
- Not pregnant and willing to use contraception.

Criteri di esclusione: 

- Plasma cell leukemia
- Amyloidosis, Waldenström's macroglobulinemia
- POEMS syndrome
- Known active CNS involvement or clinical signs of myelomatous meningeal involvement
- Previous MM maintenance treatment
- rior treatment with BCMA targeted therapy
- 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
- Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
- Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).

Numero di pazienti previsti: 

54

Schema di trattamento: 

Experimental: Arm A - Part 1 and Arm C - Part 2: Elranatamab.
Active Comparator: Arm B - Part 1 and Arm B - Part 2: Lenalidomide

Trattamento sperimentale: 

Elranatamab

Trattamento di controllo: 

Lenalidomide

Obiettivi primari dello studio: 

Progression Free Survival: Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-006052-14 - 2023-508897-27-00

Data di inserimento: 10.04.2025

Promotore

Pfizer

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na