A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)
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- Titre complet:
- 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)
- Stade ou Condition:
- Multiple Myeloma
- Phase d'étude:
- Phase 1/Phase 2
- Résumé:
- The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.
- Description détaillée:
- Non disponible
- Traitements:
- Drug : CC-92480
Specified dose on specified days
- Drug : Bortezomib
Specified dose on specified days
- Drug : Dexamethasone
Specified dose on specified days
- Drug : Daratumumab
Specified dose on specified days
- Drug : Carfilzomib
Specified dose on specified days
- Drug : Elotuzumab
Specified dose on specified days
- Drug : Isatuximab
Specified dose on specified days
- Drug : Carfilzomib
Specified dose on specified days
- Groupes d'étude:
- Experimental : Cohort A: CC-92480 with bortezomib and dexamethasone
- Experimental : Cohort C: CC-92480 with carfilzomib and dexamethasone
- Experimental : Cohort H: CC-92480 with elotuzumab and dexamethasone
- Experimental : Cohort I: CC-92480 with isatuximab and dexamethasone
- Experimental : Cohort D: CC-92480 with bortezomib and dexamethasone
- Experimental : Cohort F: CC-92480 with carfilzomib and dexamethasone
- Experimental : Cohort J: CC-92480 with elotuzumab and dexamethasone
- Experimental : Cohort K: CC-92480 with isatuximab and dexamethasone
- Experimental : Cohort G: CC-92480 with bortezomib and dexamethasone
- Experimental : Subcohort B1: CC-92480 with daratumumab and dexamethasone
- Experimental : Subcohort B2: CC-92480 with daratumumab and dexamethasone
- Experimental : Subcohort B3: CC-92480 with daratumumab and dexamethasone
- Experimental : Subcohort E1: CC-92480 with daratumumab and dexamethasone
- Experimental : Subcohort E2: CC-92480 with daratumumab and dexamethasone
- Experimental : Subcohort E3: CC-92480 with daratumumab and dexamethasone
- Type d'étude:
- Interventional
- Protocole de l'étude:
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Statut du recrutement:
- Recrutement inactif
- Critères d'admissibilités:
-
Inclusion Criteria:
-
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
For participants in Cohorts A, B, C, D, E, F, H, I, J, and K the following inclusions will
also apply:
- Documented diagnosis of multiple myeloma (MM) and measurable disease
- Documented disease progression during or after their last antimyeloma regimen
- Achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen
- Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis
- Known central nervous system (CNS) involvement with myeloma
- Received immunosuppressive medication within the last 14 days of initiating study treatment
- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment Other protocol-defined inclusion/exclusion criteria apply
- Lieux / Centres:
-
Local Institution - 201, Calgary, Alberta – ()
Local Institution - 205, Edmonton, Alberta – ()
Local Institution - 204, Halifax, Nova Scotia – ()
Local Institution - 203, Toronto, Ontario – ()
Local Institution - 202, Montreal, Quebec – ()
- Contacts:
- Non disponible
- Publications:
- ???
- Date d’affichage:
- 2019-06-18
- Date de début:
- September 30, 2019
- Dernière mise à jour:
- 2024-05-03
- Nombre d'inscriptions anticipées:
- 424
- Date de fin prévue:
- 2026-11-30
- Date de fin prévue de l'étude primaire:
- 2026-11-30
- Condition:
- Multiple Myeloma
- Genre:
- All
- Âge:
- 18 Years-N/A
- Accepte des bénévoles en santé:
- No
- Pays participants:
- Canada
- Czechia
- Denmark
- France
- Germany
- Greece
- Italy
- Spain
- United States
- Numéro d’identification:
- NCT03989414
- Autres numéros d'identification de l'étude:
- CC-92480-MM-002
- Comité de suivi des données:
- Yes
- Produit réglementé par la FDA (É-U):
- Yes
- IPD Sharing Statement :
- ???
- Responsables de l’étude:
-
Sponsor
- Commanditaires de l’étude:
- lead_sponsor
Celgene
Industry
- Collaborators:
- ???
- Chercheurs:
- Bristol-Myers Squibb Bristol-Myers Squibb
- Protocol Registration and Results System:
- ???
- Date de vérification:
- 2024-05-01