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

NCT06045806 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: CA089-10432022-501346-30U1111-1280-9736
• Study Type: interventional
• Target: 79
• Locations: 17 countries
• Sites: 99

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

Keywords

CAR-T

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS as assessed by Independent Review Committee (IRC)

  Up to approximately 50 months after the first participant is randomized

Secondary Outcomes (18)

• Overall Survival (OS)

  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

  From randomization up to 60 months from randomization

• Percentage of Participants with Minimal Residual Disease Negative (MRDneg) Complete Response (CR)

  From randomization up to 15 months from randomization

• Event-Free Survival (EFS)

  Up to approximately 60 months after the last participant is randomized

• Duration of Response (DOR)

  Up to approximately 60 months after the last participant is randomized

Study Arms (2)

Arm A

EXPERIMENTAL

Biological: idecabtagene vicleucel; Drug: Lenalidomide; Drug: Fludarabine; Drug: Cyclophosphamide

Arm B

ACTIVE COMPARATOR

Drug: Lenalidomide

Interventions

idecabtagene vicleucel BIOLOGICAL

Specified dose on specified days

Also known as: BMS-986395, Abecma, bb2121, ide-cel

Arm A

Lenalidomide DRUG

Specified dose on specified days

Also known as: Revlimid, LEN

Arm A; Arm B

Fludarabine DRUG

Specified dose on specified days

Also known as: FLUDARA, BENDARBIN

Arm A

Cyclophosphamide DRUG

Specified dose on specified days

Also known as: ENDOXAN, CYTOXAN

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead
• Bristol-Myers Squibb: collaborator
• 2seventy bio: collaborator

Study Sites (101)

Local Institution - 0131

Los Angeles, California, 90095, United States

Location

Local Institution - 0126

Orange, California, 92868, United States

Location

Local Institution - 0113

Sacramento, California, 95817, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

AdventHealth Orlando

Orlando, Florida, 32804, United States

Location

Local Institution - 0121

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0104

Atlanta, Georgia, 30342, United States

Location

Local Institution - 0151

Boston, Massachusetts, 02215, United States

Location

Ascension Providence Hospital

Southfield, Michigan, 48075, United States

Location

M Health Fairview Clinics and Surgery Center

Minneapolis, Minnesota, 55455, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Novant Health Cancer Institute - Elizabeth

Charlotte, North Carolina, 28204, United States

Location

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

Columbus, Ohio, 43210, United States

Location

Local Institution - 0132

Philadelphia, Pennsylvania, 19104, United States

Location

Local Institution - 0124

Austin, Texas, 78704, United States

Location

Local Institution - 0109

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Local Institution - 0007

Camperdown, New South Wales, 2050, Australia

Location

Local Institution - 0005

Brisbane, Queensland, 4029, Australia

Location

Local Institution - 0004

Melbourne, Victoria, 3000, Australia

Location

Local Institution - 0006

Melbourne, Victoria, 3004, Australia

Location

Local Institution - 0008

Melbourne, Victoria, 3065, Australia

Location

Local Institution - 0011

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0089

Salzburg, 5020, Austria

Location

Local Institution - 0090

Vienna, 1090, Austria

Location

Local Institution - 0083

Anderlecht, Bruxelles-Capitale, Région de, 1070, Belgium

Location

Local Institution - 0084

Brussels, Bruxelles-Capitale, Région de, 1090, Belgium

Location

Local Institution - 0144

Brussels, Bruxelles-Capitale, Région de, 1200, Belgium

Location

Local Institution - 0133

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution - 0001

Hamilton, Ontario, L8V5C2, Canada

Location

Local Institution - 0134

Montreal, Quebec, H1T 2M4, Canada

Location

Local Institution - 0070

Odense, Region Syddanmark, 5000, Denmark

Location

Local Institution - 0047

Pessac, Aquitaine, 33600, France

Location

Institut Paoli-Calmettes

Marseille, Bouches-du-Rhône, 13273, France

Location

Hopital Claude Huriez - CHU de Lille

Lille, Nord, 59000, France

Location

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

Nantes, Pays de la Loire Region, 44000, France

Location

Local Institution - 0046

Pierre-Bénite, Rhône, 69310, France

Location

Henri Mondor Hospital

Créteil, Val-de-Marne, 94010, France

Location

Local Institution - 0028

Villejuif, Val-de-Marne, 94805, France

Location

Local Institution - 0029

Poitiers, Vienne, 86021, France

Location

Local Institution - 0082

Paris, 75010, France

Location

Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

Toulouse, 31100, France

Location

Local Institution - 0031

Paris, Île-de-France Region, 75571, France

Location

Local Institution - 0072

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Local Institution - 0078

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Local Institution - 0077

Nuremberg, Bavaria, 90419, Germany

Location

Local Institution - 0073

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Local Institution - 0087

Leipzig, Saxony, 04103, Germany

Location

Local Institution - 0079

Dresden, 01307, Germany

Location

Local Institution - 0115

Essen, 45122, Germany

Location

Local Institution - 0076

Hamburg, 20246, Germany

Location

Local Institution - 0074

Würzburg, 97080, Germany

Location

Local Institution - 0063

Pátrai, Achaḯa, 26504, Greece

Location

Local Institution - 0061

Athens, Attikí, 106 76, Greece

Location

Local Institution - 0062

Chaïdári, Attikí, 12462, Greece

Location

Local Institution - 0060

Thessaloniki, Thessaloníki, 570 10, Greece

Location

Local Institution - 0058

Petah Tikva, Central District, 4910021, Israel

Location

Local Institution - 0057

Ramat Gan, Central District, 5262100, Israel

Location

Local Institution - 0055

Beersheba, Southern District, 8410101, Israel

Location

Local Institution - 0088

Tel Aviv, Tell Abīb, 6423906, Israel

Location

Local Institution - 0056

Haifa, 31096, Israel

Location

Local Institution - 0059

Jerusalem, 9112001, Israel

Location

Local Institution - 0064

Rozzano, Milano, 20089, Italy

Location

Local Institution - 0065

Bologna, 40138, Italy

Location

Local Institution - 0066

Roma, 00161, Italy

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Hyogo Medical University Hospital

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Local Institution - 0085

Isehara, Kanagawa, 259-1193, Japan

Location

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo, 150-8935, Japan

Location

Chiba University Hospital

Chiba, 260-8677, Japan

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Local Institution - 0071

Shimotsuke, 329-0498, Japan

Location

Local Institution - 0069

Oslo, 0372, Norway

Location

Local Institution - 0027

Lublin, Lublin Voivodeship, 20-090, Poland

Location

Local Institution - 0095

Warsaw, Masovian Voivodeship, 02-097, Poland

Location

Local Institution - 0023

Warsaw, Masovian Voivodeship, 02-776, Poland

Location

Local Institution - 0022

Gliwice, Silesian Voivodeship, 44-101, Poland

Location

Local Institution - 0026

Gdansk, 80-952, Poland

Location

Local Institution - 0024

Poznan, 60-569, Poland

Location

Local Institution - 0091

Bucharest, 022328, Romania

Location

Chonnam National University Hwasun Hospital

Hwasun, Jeonranamdo, 58128, South Korea

Location

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Local Institution - 0038

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Local Institution - 0043

Seoul, Seoul Teugbyeolsi, 06591, South Korea

Location

Asan Medical Center

Seoul, Seoul-teukbyeolsi, 05505, South Korea

Location

Local Institution - 0020

Badalona, Barcelona [Barcelona], 08916, Spain

Location

Local Institution - 0017

L'Hospitalet Del Llobregat, Barcelona [Barcelona], 08908, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña], 08036, Spain

Location

Local Institution - 0012

Pamplona, Navarre, 31008, Spain

Location

Local Institution - 0021

Madrid, 28041, Spain

Location

Local Institution - 0013

Salamanca, 37007, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

Local Institution - 0093

Birmingham, England, B15 2TH, United Kingdom

Location

Local Institution - 0080

London, London, City of, SE5 9RS, United Kingdom

Location

Local Institution - 0094

London, London, City of, W12 0HS, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Multiple Myeloma

Interventions

idecabtagene vicleucel; Lenalidomide; fludarabine; fludarabine phosphate; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: October 16, 2023
• Primary Completion: August 11, 2025
• Study Completion (Estimated): November 20, 2029
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

NO (1); PL (6); RO (1); JP (10); US (20); AU (6); DE (9); IT (3); FR (11); BE (3); IL (6); KR (5); DK (1); ES (7); GB (3); CA (3); GR (4)