A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants with Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505850-16-00

Acronym

68284528MMY3004

Enrollment

371

Registered

2024-04-11

Start date

2021-08-05

Completion date

Unknown

Last updated

2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Brief summary

Progression-free survival (PFS) with progression defined by IMWG criteria, or death, whichever occurred first.

Interventions

DRUGDexamethasone Tablets BP 2.0mg

DRUGFortecortin® 2 mg Tabletten

DRUGLenalidomide Accord 15 mg hard capsules

DRUGCARVYKTI 3.2 × 10^6 – 1.0 × 10^8 cells dispersion for infusion

DRUGLenalidomide Mylan 5 mg hard capsules

DRUGLenalidomide Mylan 20 mg hard capsules

DRUGVELCADE 3.5 mg powder for solution for injection

DRUGLenalidomide Accord 10 mg hard capsules

DRUGLenalidomide Accord 2.5 mg hard capsules

DRUGFLUDARABINE

DRUGLenalidomide Mylan 15 mg hard capsules

DRUGCYCLOPHOSPHAMIDE

DRUGLenalidomide Mylan 2.5 mg hard capsules

DRUGLenalidomide Accord 25 mg hard capsules

DRUGLenalidomide Accord 20 mg hard capsules

DRUGLenalidomide Mylan 10 mg hard capsules

DRUGLenalidomide Accord 5 mg hard capsules

DRUGLenalidomide Mylan 25 mg hard capsules

DRUGDexamethason 4 mg JENAPHARM®

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) with progression defined by IMWG criteria, or death, whichever occurred first.	—

Countries

Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Netherlands, Norway, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026