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Recruiting Phase 3 NCT05827016

A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

Phase 3 – large-scale trial before approval
Conditions: Multiple Myeloma

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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).
Who can participate
Inclusion 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, daratumumab + bortezomib/thalidomide/dexamethasone \[D-VTd\] and daratumumab + bortezomib/ lenalidomide/dexamethasone \[D-VRd\]), or VCd / daratumumab + bortezomib/cyclophosphamide/dexamethasone \[D-VCd\], and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted. * Participants within 12 months (single transplant) or 15 months (tandem transplant) 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.
Locations 31
Argentina (1)
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires , Buenos Aires F.D.
Dorotea Fantl, Site 0183
Australia (1)
Calvary Mater Newcastle
Waratah , New South Wales
Wojt Janowski, Site 0244
Belgium (1)
Grand Hopital de Charleroi - Les Viviers
Charleroi , WHT
Geraldine Verstraete, Site 0035
Brazil (1)
Local Institution - 0245
Curitiba , Paraná
WITHDRAWN
Canada (1)
Cross Cancer Institute
Edmonton , Alberta
Irwindeep Sandhu, Site 0270
Chile (1)
Fundación Arturo López Pérez
Santiago
Raimundo Gazitua Pepper, Site 0186
China (1)
Anhui Provincial Hospital
Hefei , AH
Colombia (1)
Oncomedica S.A.
Montería , COR
Czech Republic (1)
Fakultní Nemocnice Brno
Brno
Ludek Pour, Site 0036
Denmark (1)
Odense Universitetshospital
Odense
Jakub Krejcik, Site 0028
Finland (1)
Helsingin Yliopistollinen Sairaala (HUS) - Syopakeskus (Comprehensive Cancer Center)
Helsinki
Sini Luoma, Site 0276
France (1)
CHU Hôpital Sud
Amiens
Lydia Montes, Site 0030
Greece (1)
"General Hospital of Thessaloniki ""G. Papanikolaou"""
Thessaloniki , B
Hong Kong (1)
Queen Mary Hospital
Hong Kong , HK
Yok Lam Kwong, Site 0250
Hungary (1)
Debreceni Egyetem Klinikai Központ III. sz. Belgyógyászati Klinika
Debrecen , HB
Arpad Illes, Site 0062
India (1)
Postgraduate Institute of Medical Education & Research (PGIMER)
Chandigarh , Chandigarh
Pankaj Malhotra, Site 0128
Israel (1)
Assuta Medical Center
Ashdod
Merav Leiba, Site 0057
Italy (1)
Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco - Ospedale San Marco
Catania , CT
Francesco Di Raimondo, Site 0053
Japan (1)
National Hospital Organization (NHO) - Shibukawa Medical Center
Shibukawa-shi , Gunma
Akio Saito, Site 0106
Mexico (1)
Local Institution - 0127
Mexico City , Mexico City
WITHDRAWN
Netherlands (1)
VU University Medical Center
Amsterdam , North Holland
Niels Van de Donk, Site 0129
Poland (1)
Szpital Uniwersytecki Nr. 2 im Dr. Jana Biziela w Bydgoszczy
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
Jaroslaw Czyz, Site 0149
Romania (1)
Institutul Clinic Fundeni
Bucharest , B
Sorina Badelita, Site 0117
Singapore (1)
National University Hospital (S) Pte Ltd
Singapore
Wee Joo Chng, Site 0138
South Korea (1)
Pusan National University Hospital
Busan
Ho-Jin Shin, Site 0145
Spain (1)
Hospital Clínic de Barcelona
Barcelona , B
Laura Rosinol, Site 0226
Sweden (1)
Local Institution - 0171
Luleå , BD
WITHDRAWN
Taiwan (1)
E-DA Cancer Hospital
Kaohsiung City
Turkey (1)
Ankara Bilkent City Hospital
Ankara
Guldane Cengiz Seval, Site 0167
United Kingdom (1)
NHS Grampian - Aberdeen Royal Infirmary
Aberdeen , ABD
Stephanie Stone, Site 0173
United States (1)
Rocky Mountain Cancer Centers
Aurora , Colorado
John Burke, Site 0202
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
22.06.2023
Completion date
01.01.2036
Registry ID
NCT05827016
Source
anzctr
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