Etude : CC-92480-MM-002 /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : CC-92480-MM-002

Nom :

Traitement : Induction

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 07/07/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Phase 1/2 Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C90 - Myélome multiple et tumeurs malignes à plasmocytes
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This is an open-label, multicenter, Phase 1/2 study to determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D), and to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.

STUDY ARMS:
- Experimental: CC-92480 in combination with bortezomib and dexamethasone
Subjects in cohorts A, D and G will receive following:
Oral CC-92480 at specified cohort dose administered over a 21-day cycle
Subcutaneous bortezomib 1.3 mg/m2 administered over a 21-day cycle
Oral dexamethasone 20 mg/day (≤ 75 years old) or 10 mg/day (>75 years old) administered over a 21-day cycle

- Experimental: CC-92480 in combination with daratumumab and dexamethasone
Subjects in cohorts B and E will receive following:
Oral CC-92480 at specified cohort dose administered over a 28-day cycle
Intravenous (IV) daratumumab 16 mg/kg administered over a 28-day cycle
Oral/IV dexamethasone 40 mg weekly or 20 mg weekly for subjects older than 75 years or underweight administered over a 28-day cycle

- Experimental: CC-92480 in combination with carfilzomib and dexamethasone
Subjects in cohort C and F will receive following:
Oral CC-92480 at specified cohort dose administered over a 28-day cycle
Intravenous (IV) carfilzomib 20 mg/m2 then 56 mg/m2 administered over a 28-day cycle
Oral/IV dexamethasone 40 mg/day (20 mg/day for subjects >75 years old) administered over a 28-day cycle

CURRENT PRIMARY OUTCOME:
- Dose-limiting Toxicities (DLT) [ Time Frame: UP to approximately 2 years from enrollment ]
- Adverse Events (AEs) [ Time Frame: From first subject first visit until 28 days after the last subject discontinues study treatment. ]
- Overall response rate (ORR) [ Time Frame: UP to approximately 3 years from enrollment ]

CURRENT SECONDARY OUTCOMES:
- Time-to-response (TTR) [ Time Frame: UP to approximately 3 years from enrollment ]
- Duration of response (DOR) [ Time Frame: Up to approximately 3 years from enrollment ]
- Complete Response (CR) rate [ Time Frame: Up to approximately 3 years from enrollment ]
- Very good partial response (VGPR) rate [ Time Frame: Up to approximately 3 years from enrollment ]

Phase : I/II

Stade : NA

1 (hémato), Rechute, Réfractaire
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Subjects is ≥ 18 years of age and has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
- Relapsed or refractory subjects must have measurable disease and have documented disease progression during or after their last anti-myeloma regimen.
- Newly diagnosed subjects must have documented diagnosis with previously untreated symptomatic multiple myeloma.
- Females of childbearing potential (FCBP) and male subjects must agree with the pregnancy prevention plan.

-- Other protocol-defined inclusion/exclusion criteria may apply --

Critères de non-inclusion : - Subject has a significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis.

-- Other protocol-defined inclusion/exclusion criteria may apply --
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03989414
Promoteur :
Celgene
Type de sponsor : Industriel
Summit - New Jersey
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Thierry FACON

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Statut de l'essai : OUVERT

MAJ : 07/07/2020