A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma
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- Titre complet:
- A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)
- Stade ou Condition:
- Multiple Myeloma
- Phase d'étude:
- Phase 3
- Résumé:
- The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).
- Description détaillée:
- Non disponible
- Traitements:
- Drug : Iberdomide
Specified dose on specified days
- Drug : Lenalidomide
Specified dose on specified days
- Groupes d'étude:
- Experimental : Arm A1: Iberdomide Dose 1
- Experimental : Arm A2: Iberdomide Dose 2
- Experimental : Arm A3: Iberdomide Dose 3
- Active Comparator : Arm B: Lenalidomide
- Type d'étude:
- Interventional
- Protocole de l'étude:
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Statut du recrutement:
- En cours
- Critères d'admissibilités:
-
sion Criteria
- Confirmed diagnosis of symptomatic multiple myeloma (MM).
- Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2.
- Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) [eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)] with or without a CD38 monoclonal antibody, or Velcade® (bortezomib), cyclophosphamide, dexamethasone (VCd), and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted.
- Participants within 12 months from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria. Exclusion Criteria
- Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy.
- Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma.
- Known central nervous system/meningeal involvement of MM.
- Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years.
- Other protocol-defined Inclusion/Exclusion criteria apply.
- Lieux / Centres:
-
Cross Cancer Institute, Edmonton, Alberta – En cours
The Ottawa Hospital - General Campus, Ottawa, Ontario – En cours
Local Institution - 0307, Montreal, Quebec – À venir
CHUQ - The Hôtel-Dieu de Québec, Quebec, – En cours
- Contacts:
- Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone: 855-907-3286
Email: [email protected]
- Publications:
- ???
- Date d’affichage:
- 2023-04-24
- Date de début:
- June 22, 2023
- Dernière mise à jour:
- 2024-05-06
- Nombre d'inscriptions anticipées:
- 1216
- Date de fin prévue:
- 2036-01-01
- Date de fin prévue de l'étude primaire:
- 2029-03-15
- Condition:
- Multiple Myeloma
- Genre:
- All
- Âge:
- 18 Years-N/A
- Accepte des bénévoles en santé:
- No
- Pays participants:
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Canada
- Chile
- China
- Colombia
- Czechia
- Denmark
- Finland
- France
- Germany
- Greece
- Hong Kong
- India
- Israel
- Italy
- Japan
- Korea, Republic of
- Mexico
- Netherlands
- Poland
- Portugal
- Romania
- Singapore
- Spain
- Sweden
- Switzerland
- Taiwan
- Turkey
- United Kingdom
- United States
- Numéro d’identification:
- NCT05827016
- Autres numéros d'identification de l'étude:
- IM048-022
- 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
Bristol-Myers Squibb
Industry
- Collaborators:
- ???
- Chercheurs:
- Bristol-Myers Squibb Bristol-Myers Squibb
- Protocol Registration and Results System:
- ???
- Date de vérification:
- 2024-05-01