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RecruitingLast updated: 26 February 2024

KarMMa-9: This study is assessing how safe, tolerable and effective a type of immunotherapy called CAR T-Cell Therapy is when given in addition to lenalidomide, compared to lenalidomide alone, in people with newly diagnosed multiple myeloma who have suboptimal response after autologous stem cell transplantationA 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

Clinical summary

Summary

This study is comparing the efficacy, safety and tolerability of Idecabtagene Vicleucel with lenalidomide maintenance to that of lenalidomide maintenance.

Idecabtagene Vicleucel, which may also be known as Abecma or ide-cel, is a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapy.

Lenalidomide, which may also be known as Revlimid, works by stopping cancer cells developing, stopping blood vessels growing in the cancer, and stimulating part of the immune system to acttack the cancer cells.

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

In the Experimental Arm (Arm A), participants will receive idecabtagene vicleucel with lenalidomide maintenance therapy.

In the Active Comparator Arm (Arm B), participants will receive lenalidomide alone as maintenance therapy. 

Conditions

This trial is treating patients with newly diagnosed multiple myeloma who have received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

KarMMa-9

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb

Scientific Title

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

Eligibility

Inclusion

  • Participants aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN.
  • Participant must have received 4 to 6 cycles of induction therapy, which must contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor (PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT 80 to 120 days prior to consent. Note: Participant must not have confirmed progression since commencing induction.
  • Participant must have documented response of PR or VGPR at time of consent.
  • Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (participants with ECOG 2 due to pain because of underlying myeloma-associated bone lesions are eligible per investigator's discretion).
  • Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.

Exclusion

  • Participant with known central nervous system involvement with myeloma.
  • Participant has non-secretory MM.
  • Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection.
  • Participant has history of primary immunodeficiency.
  • Participant has previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or B-cell maturation antigen targeted therapy.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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

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