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)

March 4, 2026 updated by: Celgene

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)

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Local Institution - 0007
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Local Institution - 0005
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Local Institution - 0004
      • Melbourne, Victoria, Australia, 3004
        • Local Institution - 0006
      • Melbourne, Victoria, Australia, 3065
        • Local Institution - 0008
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 0011
  • Austria
      • Salzburg, Austria, 5020
        • Local Institution - 0089
      • Vienna, Austria, 1090
        • Local Institution - 0090
  • Belgium
    • Bruxelles-Capitale, Région de
      • Anderlecht, Bruxelles-Capitale, Région de, Belgium, 1070
        • Local Institution - 0083
      • Brussels, Bruxelles-Capitale, Région de, Belgium, 1090
        • Local Institution - 0084
      • Brussels, Bruxelles-Capitale, Région de, Belgium, 1200
        • Local Institution - 0144
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0133
    • Ontario
      • Hamilton, Ontario, Canada, L8V5C2
        • Local Institution - 0001
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Local Institution - 0134
  • Denmark
    • Region Syddanmark
      • Odense, Region Syddanmark, Denmark, 5000
        • Local Institution - 0070
  • France
      • Paris, France, 75010
        • Local Institution - 0082
      • Toulouse, France, 31100
        • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • Local Institution - 0047
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13273
        • Institut Paoli-Calmettes
    • Nord
      • Lille, Nord, France, 59000
        • Hopital Claude Huriez - CHU de Lille
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44000
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
    • Rhône
      • Pierre-Bénite, Rhône, France, 69310
        • Local Institution - 0046
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94010
        • Henri Mondor Hospital
      • Villejuif, Val-de-Marne, France, 94805
        • Local Institution - 0028
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Local Institution - 0029
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75571
        • Local Institution - 0031
  • Germany
      • Dresden, Germany, 01307
        • Local Institution - 0079
      • Essen, Germany, 45122
        • Local Institution - 0115
      • Hamburg, Germany, 20246
        • Local Institution - 0076
      • Würzburg, Germany, 97080
        • Local Institution - 0074
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Local Institution - 0072
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Local Institution - 0078
    • Bavaria
      • Nuremberg, Bavaria, Germany, 90419
        • Local Institution - 0077
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Local Institution - 0073
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Local Institution - 0087
  • Greece
    • Achaḯa
      • Pátrai, Achaḯa, Greece, 26504
        • Local Institution - 0063
    • Attikí
      • Athens, Attikí, Greece, 106 76
        • Local Institution - 0061
      • Chaïdári, Attikí, Greece, 12462
        • Local Institution - 0062
    • Thessaloníki
      • Thessaloniki, Thessaloníki, Greece, 570 10
        • Local Institution - 0060
  • Israel
      • Haifa, Israel, 31096
        • Local Institution - 0056
      • Jerusalem, Israel, 9112001
        • Local Institution - 0059
    • Central District
      • Petah Tikva, Central District, Israel, 4910021
        • Local Institution - 0058
      • Ramat Gan, Central District, Israel, 5262100
        • Local Institution - 0057
    • Southern District
      • Beersheba, Southern District, Israel, 8410101
        • Local Institution - 0055
    • Tell Abīb
      • Tel Aviv, Tell Abīb, Israel, 6423906
        • Local Institution - 0088
  • Italy
      • Bologna, Italy, 40138
        • Local Institution - 0065
      • Roma, Italy, 00161
        • Local Institution - 0066
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Local Institution - 0064
  • Japan
      • Chiba, Japan, 260-8677
        • Chiba University Hospital
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Shimotsuke, Japan, 329-0498
        • Local Institution - 0071
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Nagoya City University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Hyōgo
      • Nishinomiya, Hyōgo, Japan, 663-8501
        • Hyogo Medical University Hospital
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Kanazawa University Hospital
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Local Institution - 0085
    • Tokyo
      • Shibuya-ku, Tokyo, Japan, 150-8935
        • Japanese Red Cross Medical Center
  • Norway
      • Oslo, Norway, 0372
        • Local Institution - 0069
  • Poland
      • Gdansk, Poland, 80-952
        • Local Institution - 0026
      • Poznan, Poland, 60-569
        • Local Institution - 0024
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-090
        • Local Institution - 0027
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-097
        • Local Institution - 0095
      • Warsaw, Masovian Voivodeship, Poland, 02-776
        • Local Institution - 0023
    • Silesian Voivodeship
      • Gliwice, Silesian Voivodeship, Poland, 44-101
        • Local Institution - 0022
  • Romania
      • Bucharest, Romania, 022328
        • Local Institution - 0091
  • South Korea
    • Jeonranamdo
      • Hwasun, Jeonranamdo, South Korea, 58128
        • Chonnam National University Hwasun Hospital
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Local Institution - 0038
      • Seoul, Seoul Teugbyeolsi, South Korea, 06591
        • Local Institution - 0043
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, South Korea, 05505
        • Asan Medical Center
  • Spain
      • Madrid, Spain, 28041
        • Local Institution - 0021
      • Salamanca, Spain, 37007
        • Local Institution - 0013
      • Valencia, Spain, 46026
        • Hospital Universitari i Politècnic La Fe
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Local Institution - 0020
      • L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain, 08908
        • Local Institution - 0017
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08036
        • Hospital Clinic de Barcelona
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Local Institution - 0012
  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B15 2TH
        • Local Institution - 0093
    • London, City of
      • London, London, City of, United Kingdom, SE5 9RS
        • Local Institution - 0080
      • London, London, City of, United Kingdom, W12 0HS
        • Local Institution - 0094
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Local Institution - 0131
      • Orange, California, United States, 92868
        • Local Institution - 0126
      • Sacramento, California, United States, 95817
        • Local Institution - 0113
    • Colorado
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
    • Florida
      • Orlando, Florida, United States, 32804
        • AdventHealth Orlando
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 0121
      • Atlanta, Georgia, United States, 30342
        • Local Institution - 0104
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0151
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Ascension Providence Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • M Health Fairview Clinics and Surgery Center
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, United States, 63108
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Cancer Institute - Elizabeth
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Local Institution - 0132
    • Texas
      • Austin, Texas, United States, 78704
        • Local Institution - 0124
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Local Institution - 0109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Drug: Cyclophosphamide
Specified dose on specified days
Other Names:
  • CYTOXAN
  • ENDOXAN
Drug: Fludarabine
Specified dose on specified days
Other Names:
  • FLUDARA
  • BENDARBIN
Drug: Lenalidomide
Specified dose on specified days
Other Names:
  • Revlimid
  • LEN
Biological: idecabtagene vicleucel
Specified dose on specified days
Other Names:
  • ide-cel
  • BMS-986395
  • Abecma
  • bb2121
Active Comparator: Arm B
Drug: Lenalidomide
Specified dose on specified days
Other Names:
  • Revlimid
  • LEN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Up to approximately 50 months after the first participant is randomized

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 60 months after the last participant is randomized
Up to approximately 60 months after the last participant is randomized
Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR)
Time Frame: From randomization up to 15 months from randomization
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
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
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
Up to approximately 60 months after the last participant is randomized
Time to Progression (TTP)
Time Frame: Up to approximately 60 months after the last participant is randomized
Progression as assessed by IRC
Up to approximately 60 months after the last participant is randomized
Progression post-next line of treatment (PFS2)
Time Frame: Up to approximately 60 months after the last participant is randomized
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
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
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
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
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
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
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
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 60 months from randomization
From randomization up to 60 months from randomization
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
Up to approximately 50 months after the first participant is randomized
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
Up to approximately 50 months after the first participant is randomized
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
Up to approximately 50 months after the first participant is randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Collaborators

Bristol-Myers Squibb
2seventy bio

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2023

Primary Completion (Actual)

August 11, 2025

Study Completion (Estimated)

November 20, 2029

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA089-1043
  • 2022-501346-30 (EudraCT Number)
  • U1111-1280-9736 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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