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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 (KarMMa-9)

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ClinicalTrials.gov Identifier: NCT06045806
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : April 10, 2024
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: idecabtagene vicleucel Drug: Lenalidomide Drug: Fludarabine Drug: Cyclophosphamide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 618 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : October 16, 2023
Estimated Primary Completion Date : March 27, 2031
Estimated Study Completion Date : July 4, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A Biological: idecabtagene vicleucel
Specified dose on specified days
Other Names:
  • BMS-986395
  • Abecma
  • bb2121
  • ide-cel

Drug: Lenalidomide
Specified dose on specified days
Other Names:
  • Revlimid
  • LEN

Drug: Fludarabine
Specified dose on specified days
Other Names:
  • FLUDARA
  • BENDARBIN

Drug: Cyclophosphamide
Specified dose on specified days
Other Names:
  • ENDOXAN
  • CYTOXAN
Active Comparator: Arm B Drug: Lenalidomide
Specified dose on specified days
Other Names:
  • Revlimid
  • LEN


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Up to approximately 49 months after the first participant is randomized ]
    PFS as assessed by Independent Review Committee (IRC)


Secondary Outcome Measures :
  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 27 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 49 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 49 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 49 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045806


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT06045806    
Other Study ID Numbers: CA089-1043
2022-501346-30 ( EudraCT Number )
U1111-1280-9736 ( Other Identifier: WHO )
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: April 10, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: See plan description
Access Criteria: See plan description
URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
CAR-T
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
 Fludarabine
Lenalidomide
Idecabtagene vicleucel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances