CARTITUDE-6: This study is comparing the efficacy of combination therapy (called DVRd) followed by CAR-T cell therapy, versus DVRd followed by autologous stem cell transplant in people with newly diagnosed multiple myelomaA Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible

Summary

The researchers would like to know whether DVRd is more effective when followed by treatment with an autologous stem cell transplant (ASCT) or CAR-T cell therapy. 

DVRd consists of:

• Daratumumab, a targeted therapy which will be administered subcutaenously (an injection under the skin);
• Bortezomib, a targeted therapy which will also be administered subcutaenously;
• Lenalidomide, an oral drug which stops cancer cells developing and stimulates part of the immune system; and
• Dexamethasone, a steroid which will be administered orally.

Eligible participants will be randomly allocated to one of two treatment arms.

In the Active Comparator Arm, participants will receive DVRd + ASCT+DVRd (standard therapy).

Participants will receive DVRd for 4 induction cycles, followed by ASCT and 2 cycles of DVRd consolidation, and then lenalidomide maintenance therapy for 2 years. 

In the Experimental Arm, participants will receive DVRd followed by Ciltacabtagene Autoleucel, which is a type of CAR-T cell therapy that targets B-cell maturation antigen. 

Participants will receive DVRd for 6 induction cycles. Participants will then receive a conditioning regimen (cyclophosphamide and fludarabine) and CCilta-cel infusion, followed by lenalidomide post CAR-T cell therapy for 2 years. 

Conditions

This trial is treating patients with newly diagnosed multiple myeloma for whom high-dose therapy and ASCT are part of the intended initial treatment plan

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