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NCT Number: NCT06045806

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0007, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Idecabtagene vicleucel

Biological

Specified dose on specified days

Other names: BMS-986395, Abecma, bb2121, ide-cel

Lenalidomide

Drug

Specified dose on specified days

Other names: Revlimid, LEN

Fludarabine

Drug

Specified dose on specified days

Other names: FLUDARA, BENDARBIN

Cyclophosphamide

Drug

Specified dose on specified days

Other names: ENDOXAN, CYTOXAN

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: Up to approximately 50 months after the first participant is randomized

    PFS as assessed by Independent Review Committee (IRC)

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 60 months after the last participant is randomized

  2. Percentage of Participants with Sustained Minimal Residual Disease Negative (MRDneg) Complete Response (CR) for 12 months

    Time frame: From randomization up to 60 months from randomization

  3. Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR)

    Time frame: From randomization up to 15 months from randomization

  4. Event-Free Survival (EFS)

    Time frame: Up to approximately 60 months after the last participant is randomized

  5. Duration of Response (DOR)

    Time frame: Up to approximately 60 months after the last participant is randomized

  6. Percentage of Participants with Complete Response (CR)

    Time frame: Up to approximately 60 months after the last participant is randomized

    CR as assessed by IRC

  7. Time to Progression (TTP)

    Time frame: Up to approximately 60 months after the last participant is randomized

    Progression as assessed by IRC

  8. Progression post-next line of treatment (PFS2)

    Time frame: Up to approximately 60 months after the last participant is randomized

  9. Time to Next Treatment (TTNT)

    Time frame: Up to approximately 60 months after the last participant is randomized

  10. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: Up to approximately 60 months after the last participant is randomized

  11. Number of Participants Experiencing Adverse Events of Special Interest (AESI)

    Time frame: Up to approximately 60 months after the last participant is randomized

  12. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to approximately 60 months after the last participant is randomized

  13. Time of Maximum Observed Plasma Concentration (Tmax)

    Time frame: Up to approximately 60 months after the last participant is randomized

  14. Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D])

    Time frame: Up to 28 days post infusion

  15. Time of Last Measurable Observed Plasma Concentration (Tlast)

    Time frame: Up to approximately 60 months after the last participant is randomized

  16. Time-to-Definitive Deterioration

    Time frame: Up to approximately 50 months after the first participant is randomized

    Time-to-definitive deterioration based on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 global health status/quality of life subscale

  17. Mean Change from Baseline in EORTC QLQ-C30 Selected Subscales

    Time frame: Up to approximately 50 months after the first participant is randomized

    The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-C30 will be assessed:

    • Global health status/quality of life
    • Physical Functioning
    • Fatigue
    • Pain

  18. Mean Change from Baseline in EORTC QLQ-MY20 Selected Subscales

    Time frame: Up to approximately 50 months after the first participant is randomized

    The following subscales on the European Organization for Research and Treatment of Cancer core quality of life questionnaire EORTC QLQ-MY20 will be assessed:

    • Disease symptoms
    • Side-effects of treatment

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Collaborators

  • 2seventy bio
  • Bristol-Myers Squibb

Registry information

Official study 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 (KarMMa-9)

Acronym: KarMMa-9

Important dates

Study start
2023
Primary completion
2025
Study completion
2029
First posted
Sep 21, 2023
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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