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Active (not recruiting) Phase 3 NCT06045806

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

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

Sponsor: Celgene

trial.available_in: БГ
Overview
The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).
Who can participate
Inclusion Criteria * Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN. * Participant must have received 4 to 6 cycles of induction therapy, which must contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor (PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT 80 to 120 days prior to consent. Note: Participant must not have confirmed progression since commencing induction. * Participant must have documented response of PR or VGPR at time of consent. * Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (participants with ECOG 2 due to pain because of underlying myeloma-associated bone lesions are eligible per investigator's discretion). * Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy. Exclusion Criteria * Participant with known central nervous system involvement with myeloma. * Participant has non-secretory MM. * Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection. * Participant has history of primary immunodeficiency. * Participant has previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or B-cell maturation antigen targeted therapy. * Other protocol-defined Inclusion/Exclusion criteria apply.
Locations 16
Australia (1)
Local Institution - 0007
Camperdown , New South Wales
Belgium (1)
Local Institution - 0083
Anderlecht , Bruxelles-Capitale, Région de
Canada (1)
Local Institution - 0133
Edmonton , Alberta
Denmark (1)
Local Institution - 0070
Odense , Region Syddanmark
France (1)
Local Institution - 0047
Pessac , Aquitaine
Greece (1)
Local Institution - 0063
Pátrai , Achaḯa
Israel (1)
Local Institution - 0058
Petah Tikva , Central District
Italy (1)
Local Institution - 0064
Rozzano , Milano
Japan (1)
Nagoya City University Hospital
Nagoya , Aichi-ken
Norway (1)
Local Institution - 0069
Oslo
Poland (1)
Local Institution - 0027
Lublin , Lublin Voivodeship
Romania (1)
Local Institution - 0091
Bucharest
South Korea (1)
Chonnam National University Hwasun Hospital
Hwasun , Jeonranamdo
Spain (1)
Local Institution - 0020
Badalona , Barcelona [Barcelona]
United Kingdom (1)
Local Institution - 0093
Birmingham , England
United States (1)
Local Institution - 0131
Los Angeles , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
16.10.2023
Completion date
20.11.2029
Registry ID
NCT06045806
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.