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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
79

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain the NCT# and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

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 Politecnic 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bristol-Myers Squibb
2seventy bio

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 11, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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