A randomized phase III trial comparing daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) followed by ciltacabtagene-autoleucel versus DVRd followed by autologous stem cell transplantation (ASZT) in study participants with newly diagnosed multiple myeloma who are eligible for transplantation
Aim of the study
The main objective of the study is to assess how well Ciltacabtagen-Autoleucel (Cilta-cel) works compared to standard treatment with autologous stem cell transplantation (ASZT). Cilta-cel is a CAR T-cell therapy. In this form of treatment, your white blood cells (which are part of the immune system) are genetically modified so that they become Cilta-cel. These cells are then used to treat your multiple myeloma (MM).
Who can take part?
Newly diagnosed multiple myeloma
Procedure
If you decide to take part in the study, you will be randomly assigned to one of two treatment groups (study arm A and study arm B), as described in more detail below.
The duration of study is ±15 years. The treatment lasts ±3 years. The exact period depends on how the disease responds to treatment.
The following number of study-related visits are expected to take place:
- Treatment arm A: max. 200 visits to patients who participate in the study for 15 years without disease progression.
- Treatment arm B: max. 222 visits to patients participating in the study for 15 years without disease progression.
Compensation
Original study name
Randomized phase III trial comparing DVRd followed by Cilta-cel vs. DVRd followed by autologous stem cell transplantation in study participants with newly diagnosed multiple myeloma who are eligible for transplantation
BASEC number
2022-01360
Sponsors
Stitching European Myeloma Network