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RecruitingLast updated: 1 May 2024

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

Clinical summary

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

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

CARTITUDE-6

More information

Trial Identifiers

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Trial sponsor

Stichting European Myeloma Network

Scientific Title

A 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

Eligibility

Inclusion

  • Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan.
  • Measurable disease, as assessed by central laboratory, at screening as defined by any of the following:

    1. Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
    2. Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
  • ECOG performance status of grade 0 or 1
  • Clinical laboratory values within prespecified range.

Exclusion

  • Prior treatment with CAR-T therapy directed at any target.
  • Any prior BCMA target therapy.
  • Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids
  • Received a strong cytochrome P450 (CYP)3A4 inducer within 5 half-lives prior to randomization
  • Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization.
  • Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
  • Stroke or seizure within 6 months of signing Informed Consent Form (ICF)

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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