CA089-1043 - KarMMA-9 - Ide-Cel with LEN Maintenance vs LEN Maintenance Therapy Alone in NDMM Pts
Research type
Research Study
Full title
A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel with Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants with Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)
IRAS ID
1004015
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Celgene Corp.
Research summary
The primary objective of the study is to evaluate the length of time during and after treatment that a participant can live with multiple myeloma that does not get worse (known as progression free survival (PFS)). This will be done by assessing the safety and efficacy of Ide-cel (the investigational CAR-T cell therapy product) in combination with Lenalidomide (LEN) in comparison to LEN therapy given alone to participants, who have newly diagnosed multiple myeloma (NDMM) & have achieved a sub-optimal response to autologous stem cell transplantation (ASCT). The study will also measure other parameters such as, but not limited to, overall survival, efficacy parameters, the seriousness and frequency of side effects from Ide-cel with LEN relative to LEN given alone, cellular pharmacokinetics (expansion & persistence of CAR-T cells in the blood), and participant's quality of life.
NDMM patients who achieve less than complete response (CR) post ASCT are at higher risk of progressive disease/death compared to patients who achieve CR, which underscores the need for optimal treatment in this clinically high-risk population. Based on previous clinical studies, Ide-cel indicates the potential to deepen response and extend PFS. Further, Ide-cel followed by LEN therapy has resulted in favourable responses. Therefore, the assumption of this study is that ide-cel with LEN can increase PFS in participants compared to LEN therapy maintenance given alone.
This is a phase 3 study involving participants aged 18 years and over. The study consists of 3 phases: Screening, Treatment Period and Follow-up Period. The expected total primary study duration is up to approximately 7.5 years (89 months). If participants meet the eligibility requirements, they will have a 50% chance of randomisation to Arm A (Ide-cel with LEN) or Arm B (LEN therapy only).
About 687 participants from different countries across the world will be recruited to the study, with 20 participants from the UK.
REC name
North East - York Research Ethics Committee
REC reference
24/NE/0002
Date of REC Opinion
21 Feb 2024
REC opinion
Further Information Favourable Opinion