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A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT05827016
Recruitment Status : Recruiting
First Posted : April 24, 2023
Last Update Posted : April 10, 2024
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Iberdomide Drug: Lenalidomide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : June 22, 2023
Estimated Primary Completion Date : March 15, 2029
Estimated Study Completion Date : January 1, 2036

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A1: Iberdomide Dose 1 Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382
Experimental: Arm A2: Iberdomide Dose 2 Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382
Experimental: Arm A3: Iberdomide Dose 3 Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382
Active Comparator: Arm B: Lenalidomide Drug: Lenalidomide
Specified dose on specified days
Other Name: Revlimid®


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Up to 6 years ]

Secondary Outcome Measures :
  1. Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (± 3) months of maintenance treatment [ Time Frame: Up to 6 years ]
  2. Overall Survival [ Time Frame: Up to 12 years ]
  3. Recommended iberdomide dose for Stage 2 [ Time Frame: Up to 1 year ]
  4. Area under the iberdomide plasma concentration-time curve from time zero to tau [ Time Frame: Up to 1 year ]
  5. Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU) [ Time Frame: Up to 1 year ]
  6. Maximum iberdomide concentration (Cmax) [ Time Frame: Up to 1 year ]
  7. Time to maximum iberdomide plasma concentration (Tmax) [ Time Frame: Up to 1 year ]
  8. Number of participants with adverse events (AEs) [ Time Frame: Up to 6 years ]
  9. Progression-free survival on next line of treatment (PFS2) [ Time Frame: Up to 6 years ]
  10. Achieving MRD negativity in participants with CR or better at any time after the date of randomization [ Time Frame: Up to 6 years ]
  11. Conversion from MRD positive to MRD negative in participants with CR or better [ Time Frame: Up to 6 years ]
  12. Achievement of CR or better and maintaining MRD-negative status in 2 bone marrow aspirate assessments that are a minimum of 6 months or 1 year apart, without any examination showing MRD positive status in between assessments [ Time Frame: Up to 6 years ]
  13. Time to progression (TTP) [ Time Frame: Up to 6 years ]
  14. Time to next treatment (TTNT) [ Time Frame: Up to 6 years ]
  15. Best response achieved prior to progressive disease (PD) [ Time Frame: Up to 6 years ]
  16. Patient-reported health-related quality of life (HRQoL) outcomes and multiple myeloma-related symptoms as measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life C30 questionnaire (QLQ-C30) [ Time Frame: Up to 6 years ]
  17. Patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the EORTC Quality of Life Multiple Myeloma Module (QLQ-MY20) [ Time Frame: Up to 6 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05827016


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT # and Site #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05827016    
Other Study ID Numbers: IM048-022
2022-501515-14 ( EudraCT Number )
U1111-1280-9492 ( Registry Identifier: WHO )
First Posted: April 24, 2023    Key Record Dates
Last Update Posted: April 10, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/disclosurecommitment.html
Supporting Materials: 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/disclosure-commitment.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Multiple Myeloma
Iberdomide
CC-220
Lenalidomide
MM
 NDMM
Maintenance
Autologous stem cell transplant
ASCTm
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
 Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents