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

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	idecabtagene vicleucel	Specified dose on specified days
DRUG	Lenalidomide	Specified dose on specified days
DRUG	Fludarabine	Specified dose on specified days
DRUG	Cyclophosphamide	Specified dose on specified days

Timeline

• Start date: 2023-10-16
• Primary completion: 2025-08-11
• Completion: 2029-11-20
• First posted: 2023-09-21
• Last updated: 2026-03-05

Locations

101 sites across 18 countries: United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Japan, Norway, Poland, Romania, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study