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

NCT ID: NCT06045806

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 618 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2025-08-11

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).

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Group Type: EXPERIMENTAL

idecabtagene vicleucel

Intervention Type: BIOLOGICAL

Specified dose on specified days

Lenalidomide

Intervention Type: DRUG

Specified dose on specified days

Fludarabine

Intervention Type: DRUG

Specified dose on specified days

Cyclophosphamide

Intervention Type: DRUG

Specified dose on specified days

Arm B

Group Type: ACTIVE_COMPARATOR

Lenalidomide

Intervention Type: DRUG

Specified dose on specified days

Interventions

idecabtagene vicleucel

Specified dose on specified days

Intervention Type: BIOLOGICAL

Lenalidomide

Specified dose on specified days

Intervention Type: DRUG

Fludarabine

Specified dose on specified days

Intervention Type: DRUG

Cyclophosphamide

Specified dose on specified days

Intervention Type: DRUG

Other Intervention Names

BMS-986395; Abecma; bb2121; ide-cel; Revlimid; LEN; FLUDARA; BENDARBIN; ENDOXAN; CYTOXAN

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

2seventy bio

INDUSTRY

Sponsor Role: collaborator

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution - 0131

Los Angeles, California, United States

Local Institution - 0126

Orange, California, United States

Local Institution - 0113

Sacramento, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

AdventHealth Orlando

Orlando, Florida, United States

Local Institution - 0121

Atlanta, Georgia, United States

Local Institution - 0104

Atlanta, Georgia, United States

Local Institution - 0151

Boston, Massachusetts, United States

Ascension Providence Hospital

Southfield, Michigan, United States

M Health Fairview Clinics and Surgery Center

Minneapolis, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Columbia University Irving Medical Center

New York, New York, United States

Novant Health Cancer Institute - Elizabeth

Charlotte, North Carolina, United States

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Local Institution - 0132

Philadelphia, Pennsylvania, United States

Local Institution - 0124

Austin, Texas, United States

Local Institution - 0109

Houston, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Local Institution - 0007

Camperdown, New South Wales, Australia

Local Institution - 0005

Brisbane, Queensland, Australia

Local Institution - 0004

Melbourne, Victoria, Australia

Local Institution - 0006

Melbourne, Victoria, Australia

Local Institution - 0008

Melbourne, Victoria, Australia

Local Institution - 0011

Murdoch, Western Australia, Australia

Local Institution - 0089

Salzburg, , Austria

Local Institution - 0090

Vienna, , Austria

Local Institution - 0083

Anderlecht, Bruxelles-Capitale, Région de, Belgium

Local Institution - 0084

Brussels, Bruxelles-Capitale, Région de, Belgium

Local Institution - 0144

Brussels, Bruxelles-Capitale, Région de, Belgium

Local Institution - 0133

Edmonton, Alberta, Canada

Local Institution - 0001

Hamilton, Ontario, Canada

Local Institution - 0134

Montreal, Quebec, Canada

Local Institution - 0070

Odense, Region Syddanmark, Denmark

Local Institution - 0047

Pessac, Aquitaine, France

Institut Paoli-Calmettes

Marseille, Bouches-du-Rhône, France

Hopital Claude Huriez - CHU de Lille

Lille, Nord, France

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

Nantes, Pays de la Loire Region, France

Local Institution - 0046

Pierre-Bénite, Rhône, France

Henri Mondor Hospital

Créteil, Val-de-Marne, France

Local Institution - 0028

Villejuif, Val-de-Marne, France

Local Institution - 0029

Poitiers, Vienne, France

Local Institution - 0082

Paris, , France

Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

Toulouse, , France

Local Institution - 0031

Paris, Île-de-France Region, France

Local Institution - 0072

Heidelberg, Baden-Wurttemberg, Germany

Local Institution - 0078

Ulm, Baden-Wurttemberg, Germany

Local Institution - 0077

Nuremberg, Bavaria, Germany

Local Institution - 0073

Cologne, North Rhine-Westphalia, Germany

Local Institution - 0087

Leipzig, Saxony, Germany

Local Institution - 0079

Dresden, , Germany

Local Institution - 0115

Essen, , Germany

Local Institution - 0076

Hamburg, , Germany

Local Institution - 0074

Würzburg, , Germany

Local Institution - 0063

Pátrai, Achaḯa, Greece

Local Institution - 0061

Athens, Attikí, Greece

Local Institution - 0062

Chaïdári, Attikí, Greece

Local Institution - 0060

Thessaloniki, Thessaloníki, Greece

Local Institution - 0058

Petah Tikva, Central District, Israel

Local Institution - 0057

Ramat Gan, Central District, Israel

Local Institution - 0055

Beersheba, Southern District, Israel

Local Institution - 0088

Tel Aviv, Tell Abīb, Israel

Local Institution - 0056

Haifa, , Israel

Local Institution - 0059

Jerusalem, , Israel

Local Institution - 0064

Rozzano, Milano, Italy

Local Institution - 0065

Bologna, , Italy

Local Institution - 0066

Roma, , Italy

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Local Institution - 0085

Isehara, Kanagawa, Japan

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo, Japan

Chiba University Hospital

Chiba, , Japan

Kyushu University Hospital

Fukuoka, , Japan

Okayama University Hospital

Okayama, , Japan

Local Institution - 0071

Shimotsuke, , Japan

Local Institution - 0069

Oslo, , Norway

Local Institution - 0027

Lublin, Lublin Voivodeship, Poland

Local Institution - 0095

Warsaw, Masovian Voivodeship, Poland

Local Institution - 0023

Warsaw, Masovian Voivodeship, Poland

Local Institution - 0022

Gliwice, Silesian Voivodeship, Poland

Local Institution - 0026

Gdansk, , Poland

Local Institution - 0024

Poznan, , Poland

Local Institution - 0091

Bucharest, , Romania

Chonnam National University Hwasun Hospital

Hwasun, Jeonranamdo, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Local Institution - 0038

Seoul, Seoul Teugbyeolsi, South Korea

Local Institution - 0043

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center

Seoul, Seoul-teukbyeolsi, South Korea

Local Institution - 0020

Badalona, Barcelona [Barcelona], Spain

Local Institution - 0017

L'Hospitalet Del Llobregat, Barcelona [Barcelona], Spain

Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña], Spain

Local Institution - 0012

Pamplona, Navarre, Spain

Local Institution - 0021

Madrid, , Spain

Local Institution - 0013

Salamanca, , Spain

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Local Institution - 0093

Birmingham, England, United Kingdom

Local Institution - 0080

London, London, City of, United Kingdom

Local Institution - 0094

London, London, City of, United Kingdom

Countries

United States; Australia; Austria; Belgium; Canada; Denmark; France; Germany; Greece; Israel; Italy; Japan; Norway; Poland; Romania; South Korea; Spain; United Kingdom

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06045806.html

BMS Clinical Trial Patient Recruiting

Other Identifiers

2022-501346-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1280-9736

Identifier Type: OTHER

Identifier Source: secondary_id

CA089-1043

Identifier Type: -

Identifier Source: org_study_id

NCT06399393

Identifier Type: -

Identifier Source: nct_alias