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Clinical Trials in the UK / NCT06045806
Active, not recruiting Phase 3

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

NCT06045806 · tracked via the Priya Life Science UK tracker
Sponsor
Celgene
Phase
Phase 3
Started
2023-10-16
Last updated
2026-03-05

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

idecabtagene vicleucelLenalidomideFludarabineCyclophosphamide

idecabtagene vicleucel: Specified dose on specified days

Lenalidomide: Specified dose on specified days

Fludarabine: Specified dose on specified days

Cyclophosphamide: Specified dose on specified days

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (101)

FacilityCityRegionStatus
Local Institution - 0131 Los Angeles California
Local Institution - 0126 Orange California
Local Institution - 0113 Sacramento California
Colorado Blood Cancer Institute Denver Colorado
Yale University School of Medicine New Haven Connecticut
AdventHealth Orlando Orlando Florida
Local Institution - 0121 Atlanta Georgia
Local Institution - 0104 Atlanta Georgia
Local Institution - 0151 Boston Massachusetts
Ascension Providence Hospital Southfield Michigan
M Health Fairview Clinics and Surgery Center Minneapolis Minnesota
Washington University School of Medicine St Louis Missouri
Washington University School of Medicine St Louis Missouri
Columbia University Irving Medical Center New York New York
Novant Health Cancer Institute - Elizabeth Charlotte North Carolina
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Columbus Ohio
Local Institution - 0132 Philadelphia Pennsylvania
Local Institution - 0124 Austin Texas
Local Institution - 0109 Houston Texas
University of Texas MD Anderson Cancer Center Houston Texas
Local Institution - 0007 Camperdown New South Wales
Local Institution - 0005 Brisbane Queensland
Local Institution - 0004 Melbourne Victoria
Local Institution - 0006 Melbourne Victoria
Local Institution - 0008 Melbourne Victoria
Local Institution - 0011 Murdoch Western Australia
Local Institution - 0089 Salzburg Austria
Local Institution - 0090 Vienna Austria
Local Institution - 0083 Anderlecht Bruxelles-Capitale, Région de
Local Institution - 0084 Brussels Bruxelles-Capitale, Région de
Local Institution - 0144 Brussels Bruxelles-Capitale, Région de
Local Institution - 0133 Edmonton Alberta
Local Institution - 0001 Hamilton Ontario
Local Institution - 0134 Montreal Quebec
Local Institution - 0070 Odense Region Syddanmark
Local Institution - 0047 Pessac Aquitaine
Institut Paoli-Calmettes Marseille Bouches-du-Rhône
Hopital Claude Huriez - CHU de Lille Lille Nord
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu Nantes Pays de la Loire Region
Local Institution - 0046 Pierre-Bénite Rhône

+ 61 more sites — see the full list on the official registry below.

On this site

📄 Revlimid (lenalidomide) drug profile →

More Celgene trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06045806 on ClinicalTrials.gov ↗ ← All trials in the UK