A Study to Compare the Efficacy and Safety of Idecabtagen... | NCT06045806

Studies
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

Sponsor

Celgene

Status

Active, not recruiting

Last Update Posted

Mar 5, 2026Actual

Enrollment

79Actual

Phase

Phase 3

Conditions

Multiple Myeloma

Interventions

idecabtagene vicleucel
Lenalidomide
Fludarabine
Cyclophosphamide

Countries

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

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2022-501346-30	EudraCT Number
U1111-1280-9736	Other Identifier	WHO

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 16, 2023Actual

Primary Completion Date

Aug 11, 2025Actual

Completion Date

Nov 20, 2029Estimated

First Submitted Date

Sep 13, 2023

First Submission Date that Met QC Criteria

Sep 13, 2023

First Posted Date

Sep 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2026

Last Update Posted Date

Mar 5, 2026Actual

Name	Class
Bristol-Myers Squibb	INDUSTRY
2seventy bio	INDUSTRY

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

79Actual

Label	Type	Description	Intervention Names
Arm A	Experimental		Biological: idecabtagene vicleucel Drug: Lenalidomide Drug: Fludarabine Drug: Cyclophosphamide
Arm B	Active Comparator		Drug: Lenalidomide

Name	Type	Description	Arm Group Labels	Other Names
idecabtagene vicleucel	Biological	Specified dose on specified days	Arm A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0131		Los Angeles	California	90095	United States
Local Institution - 0126

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

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

Types

Study Protocol
Statistical Analysis Plan (SAP)
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.html

Ancestor Terms

ID	Term
D010797	Phthalimides
D010795	Phthalic Acids
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010881	Piperidones
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D054833	Isoindoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D006838	Hydrocarbons
D063088	Phosphoramides
D009943	Organophosphorus Compounds

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
C000715380	idecabtagene vicleucel
D000077269	Lenalidomide
C024352	fludarabine
C042382	fludarabine phosphate
D003520	Cyclophosphamide