Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Pfizer (Voir sur ClinicalTrials)
mars 2022
octobre 2029
02 septembre 2025
The purpose of this study is to evaluate whether elranatamab monotherapy can provide
clinical benefit compared to lenalidomide monotherapy (control) in participants with
newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In
Part 1 and Part 2 of the study, participants in the study will either receive elranatamab
(arm A and C) as an injection under the skin at the study clinic or lenalidomide orally
once daily at home (arm B). Participation in the study will be approximately five years
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Alina DANU | 03/06/2024 13:22:21 | Contacter | ||
Critères
Tous
- 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
Exclusion Criteria:
- Plasma cell leukemia
- Amyloidosis, Waldenström's macroglobulinemia
- POEMS syndrome
- Known active CNS involvement or clinical signs of myelomatous meningeal involvement
- Previous MM maintenance treatment
- Prior 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)