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
Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
Istituto di Ematologia 'L. e A. Seragnoli'
IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC
Riferimento: Dr. Claudio Cerchione
Email: claudio.cerchione@irst.emr.it
IRCCS Ca' Granda Ospedale Maggiore Policlinico
Via Francesco Sforza 35 - 20122 Milano - MI
UOC Ematologia
Telefono: 0255033422
Email: ematologia@policlinico.mi.it
Ospedale Riuniti Umberto I - Lancisi-Salesi
Via Conca 71 - 60020 Ancona - AN
Clinica Ematologica
Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
UOC Unità Operativa Complessa Servizio e DH di Ematologia
Università La Sapienza Policlinico Umberto I
Viale del Policlinico 155 - 00161 Roma - RM
Riferimento: Prof. Maurizio Martelli
Email: martelli@bce.uniroma1.it
Azienda Ospedaliera Universitaria Senese
Viale Bracci 16 - 53100 Siena - SI
Riferimento: Prof.ssa Monica Bocchia
Email: segr.ematologia@ao-siena.toscana.it
AOU Policlinico Vittorio Emanuele PO G. Rodolico
Via S. Sofia 78 - 95123 Catania - CT
Riferimento: Prof. Francesco Di Raimondo
Email: diraimon@unict.it
Numero di iscrizione a registro: 2021-006052-14 - 2023-508897-27-00
Data di inserimento: 10.04.2025
Pfizer
Riferimento: Dr. Info non applicabile
Telefono: 00000
Email: na@na.it
Localita: na