Détails de l'étude

MajesTEC-9 : Étude de phase III à répartition aléatoire comparant le téclistamab en monothérapie à l’association de pomalidomide, de bortézomib et de dexaméthasone (PVd) ou à l’association de carfilzomib et de dexaméthasone (Kd) chez des participants atteints de myélome multiple récidivant ou réfractaire ayant reçu 1 à 3 traitements antérieurs, dont l’association d’un anticorps monoclonal anti-CD38 et de lénalidomide 

Type de maladie :
Traitement :
Population :
Rechute et réfractaire
Thérapie ciblée
Adultes
  • Documented diagnosis of multiple myeloma
  • Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line
  • Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator’s determination of response by International myeloma working group (IMWG) criteria
  • ECOG of 0 to 2
  • A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
  • Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
  • Received any prior B cell maturation antigen (BCMA)-directed therapy
  • A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (>=) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic blood pressure >99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade >=3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event [AE] related to carfilzomib)
  • Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma.
  • Received a live, attenuated vaccine within 4 weeks before randomization
  • Plasma cell leukemia at the time of screening, Waldenstrom’s macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin changes, or primary amyloid light chain amyloidosis
  • Received a maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14 days prior to randomization

CIUSSS de l’Est-de-l’Ile-de-Montreal

Autres études

MonumenTAL-6 :Étude de phase 3 avec répartition aléatoire comparant le talquétamab en association avec la pomalidomide (Tal-P), le talquétamab en association avec le téclistamab (Tal-Tec) et une association choisie par l’investigateur composée d’élotuzumab, de pomalidomide et de dexaméthasone (EPd) ou de pomalidomide, de bortézomib et de dexaméthasone (PVd), chez des participants atteints d’un myélome récidivant ou réfractaire ayant déjà reçu de 1 à 4 traitements comprenant un anticorps anti-CD38 et de la lénalidomide