Full Title:

A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)

Myeloma stage or condition:

Multiple Myeloma

Study phase:

Phase 3

Summary/Purpose:

The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).

Detailed Description:

Not available

Treatments:

Drug : Iberdomide

Specified dose on specified days

Drug : Lenalidomide

Specified dose on specified days

Study Arms:

Experimental : Arm A1: Iberdomide Dose 1

Experimental : Arm A2: Iberdomide Dose 2

Experimental : Arm A3: Iberdomide Dose 3

Active Comparator : Arm B: Lenalidomide

Study Type:

Interventional

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Recruitment status:

Recruiting

Eligibility criteria:

sion Criteria

Confirmed diagnosis of symptomatic multiple myeloma (MM).

Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2.

Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) [eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)] with or without a CD38 monoclonal antibody, or Velcade® (bortezomib), cyclophosphamide, dexamethasone (VCd), and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted.

Participants within 12 months from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria. Exclusion Criteria

Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy.

Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma.

Known central nervous system/meningeal involvement of MM.

Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years.

Other protocol-defined Inclusion/Exclusion criteria apply.

Locations / Centres:

Cross Cancer Institute, Edmonton, Alberta – Recruiting

The Ottawa Hospital - General Campus, Ottawa, Ontario – Recruiting

Local Institution - 0307, Montreal, Quebec – Not yet recruiting

CHUQ - The Hôtel-Dieu de Québec, Quebec, – Recruiting

Contacts:

Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone: 855-907-3286
Email: [email protected]

Publications:

???

First posted:

2023-04-24

Actual start date:

June 22, 2023

Last updated:

2024-05-13

Estimated enrollment:

1216

Estimated completion date:

2036-01-01

Estimated primary completion date:

2029-03-15

Condition:

Multiple Myeloma

Gender:

All

Ages:

18 Years-N/A

Accepts healthy volunteers:

No

Listed location countries:

Argentina

Australia

Austria

Belgium

Brazil

Canada

Chile

China

Colombia

Czechia

Denmark

Finland

France

Germany

Greece

Hong Kong

India

Israel

Italy

Japan

Korea, Republic of

Mexico

Netherlands

Poland

Portugal

Romania

Singapore

Spain

Sweden

Switzerland

Taiwan

Turkey

United Kingdom

United States

NCT number:

NCT05827016

Other study ID numbers:

IM048-022

Has Data monitoring committee:

Yes

U.S. FDA-regulated product:

Yes

IPD Sharing Statement :

???

Responsible party:

Sponsor

Study sponsor:

lead_sponsor
Bristol-Myers Squibb
Industry

Collaborators:

???

Investigators:

Bristol-Myers Squibb Bristol-Myers Squibb

Protocol Registration and Results System:

???

Verification date:

2024-05-01