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A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma

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Titre complet:
An Exploratory Phase 1b/2a Multicenter, Open-Label, Novel-Novel Combination Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CC-92480 (BMS-986348) in Novel Therapeutic Combinations in Participants With Relapsed or Refractory Multiple Myeloma
Stade ou Condition:
Multiple Myeloma
Phase d'étude:
Phase 1/Phase 2
Résumé:
The purpose of this study is to assess the safety, tolerability and preliminary effectiveness of CC-92480 (BMS-986348) in novel therapeutic combinations for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM).
Description détaillée:
Non disponible
Traitements:
Drug : CC-92480

Specified dose on specified days

Drug : Tazemetostat

Specified dose on specified days

Drug : BMS-986158

Specified dose on specified days

Drug : Trametinib

Specified dose on specified days

Drug : Dexamethasone

Specified dose on specified days

Groupes d'étude:
Experimental : Part 1 Arm A: Dose Finding
Experimental : Part 1 Arm B: Dose Finding
Experimental : Part 1 Arm C: Dose Finding
Active Comparator : Part 2 Arm D: Dose Expansion
Experimental : Part 2 Arm E: Dose Expansion
Experimental : Part 2 Arm F: Dose Expansion
Experimental : Part 2 Arm G: Dose Expansion
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:
En cours
Critères d'admissibilités:
Inclusion Criteria:
  • Relapsed or refractory multiple myeloma (MM) and must: 1. have documented disease progression during or after their last myeloma therapy 2. be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM
  • Must have measurable disease
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP)
Exclusion Criteria:
  • Known active or history of central nervous system (CNS) involvement of MM
  • Plasma cell leukemia; Waldenstrom's macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis.
  • Impaired cardiac function or clinically significant cardiac disease
  • Previous SARS-CoV-2 infection within 14 days for asymptomatic or mild symptomatic infections or 28 days for severe/critical illness prior to Cycle 1 Day 1 (C1D1)
  • For Part 1: received prior therapy with CC-92480
  • For Part 2: received prior therapy with CC-92480, tazemetostat, BMS-986158, or trametinib
  • Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment
  • Received any of the following within 14 days prior to initiating study treatment: 1. Plasmapheresis 2. Major surgery 3. Radiation therapy other than local therapy for myeloma associated bone lesions 4. Use of any systemic anti-myeloma drug therapy
  • Used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment
  • COVID-19 vaccine within 14 days prior to C1D1 Other protocol-defined inclusion/exclusion criteria apply
Lieux / Centres:

Alberta Health Services AHS - Foothills Medical Centre FMC, Calgary, Alberta – En cours

University of Alberta - Cross Cancer Institute, Edmonton, Alberta – En cours

University Health Network UHN - Princess Margaret Hospital PMH, Toronto, Ontario – En cours

Contacts:
Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone: 855-907-3286
Email: [email protected]
Publications:
???
Date d’affichage:
2022-05-12
Date de début:
October 18, 2022
Dernière mise à jour:
2024-02-26
Nombre d'inscriptions anticipées:
220
Date de fin prévue:
2026-10-12
Date de fin prévue de l'étude primaire:
2026-10-12
Condition:
Multiple Myeloma
Genre:
All
Âge:
18 Years-N/A
Accepte des bénévoles en santé:
No
Pays participants:
Canada
Norway
Spain
United Kingdom
United States
Numéro d’identification:
NCT05372354
Autres numéros d'identification de l'étude:
CA057-003
Comité de suivi des données:
No
Produit réglementé par la FDA (É-U):
Yes
IPD Sharing Statement :
???
Responsables de l’étude:
Sponsor
Commanditaires de l’étude:
lead_sponsor
Bristol-Myers Squibb
Industry
Collaborators:
???
Chercheurs:
Bristol-Myers Squibb Bristol-Myers Squibb
Protocol Registration and Results System:
???
Date de vérification:
2024-02-01