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)

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

Tracking Information

• First Submitted Date: September 13, 2023
• First Posted Date: September 21, 2023
• Last Update Posted Date: April 10, 2024
• Actual Study Start Date: October 16, 2023
• Estimated Primary Completion Date: March 27, 2031 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 2023)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 13, 2023)

• Overall Survival (OS) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
• 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 ]
• Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR) [ Time Frame: From randomization up to 15 months from randomization ]
• Event-Free Survival (EFS) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
• Duration of Response (DOR) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
• 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
• Time to Progression (TTP) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
  Progression as assessed by IRC
• Progression post-next line of treatment (PFS2) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
• Time to Next Treatment (TTNT) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
• Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
• Number of Participants Experiencing Adverse Events of Special Interest (AESI) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
• Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
• Time of Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
• Area Under the Curve (AUC) from time zero to 28 days post infusion (AUC [0- 28D]) [ Time Frame: Up to 28 days post infusion ]
• Time of Last Measurable Observed Plasma Concentration (Tlast) [ Time Frame: Up to approximately 60 months after the last participant is randomized ]
• 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
• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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)
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Multiple Myeloma

Intervention

• 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

Study Arms

• Experimental: Arm A
  Interventions:

  • Biological: idecabtagene vicleucel
  • Drug: Lenalidomide
  • Drug: Fludarabine
  • Drug: Cyclophosphamide
• Active Comparator: Arm B
  Intervention: Drug: Lenalidomide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 13, 2023): 618
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 4, 2032
• Estimated Primary Completion Date: March 27, 2031 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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 #.

• Listed Location Countries: Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Norway, Poland, Romania, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT06045806
• Other Study ID Numbers: CA089-1043; 2022-501346-30 ( EudraCT Number ); U1111-1280-9736 ( Other Identifier: WHO )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: 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

• Current Responsible Party: Bristol-Myers Squibb
• Original Responsible Party: Same as current
• Current Study Sponsor: Bristol-Myers Squibb
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: April 2024