A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) (ALUMMINATE)

• ClinicalTrials.gov Identifier: NCT06232707
• Recruitment Status: Not yet recruiting
• First Posted: January 31, 2024
• Last Update Posted: March 28, 2024
• Sponsor: Celgene
• Information provided by (Responsible Party): Celgene

Tracking Information

• First Submitted Date: January 22, 2024
• First Posted Date: January 31, 2024
• Last Update Posted Date: March 28, 2024
• Estimated Study Start Date: March 29, 2024
• Estimated Primary Completion Date: November 16, 2025 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 22, 2024): Progression-free Survival (PFS) [ Time Frame: Up to 5 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 22, 2024)

• Overall Survival (OS) [ Time Frame: Up to 5 years ]
• Overall response (OR) [ Time Frame: Up to 5 years ]
• Complete response (CR) or better [ Time Frame: Up to 5 years ]
• Very good partial response (VGPR) or better [ Time Frame: Up to 5 years ]
• Time to response (TTR) [ Time Frame: Up to 5 years ]
• Duration of response (DOR) [ Time Frame: Up to 5 years ]
• Time to progression (TTP) [ Time Frame: Up to 5 years ]
• Time to next treatment (TTNT) [ Time Frame: Up to 5 years ]
• Progression-free survival 2 (PFS2) [ Time Frame: Up to 5 years ]
• Restricted mean DOR (RMDOR) [ Time Frame: Up to 5 years ]
• Minimal residual disease (MRD) negativity rate [ Time Frame: Up to 5 years ]
• Incidence of adverse events (AEs) [ Time Frame: Up to 5 years ]
• Incidence of serious adverse events (SAEs) [ Time Frame: Up to 5 years ]
• Change from baseline in subscale scores of European organization for research and treatment of cancer - quality of life core 30 (EORTC QLQ-C30) [ Time Frame: Up to 5 years ]
• Change from baseline in subscale scores of European quality of life multiple myeloma module (EORTC QLQ-MY20) [ Time Frame: Up to 5 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
• Official Title: A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMM
• Brief Summary: The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Multiple Myeloma

Intervention

• Drug: Alnuctamab
  Specified dose on specified days
  Other Names:

  • BMS-986349
  • CC-93269
• Drug: Pomalidomide
  Specified dose on specified days
  Other Names:

  • POMALYST®
  • IMNOVID®
  • CC-4047
  • BMS-986379
• Drug: Daratumumab
  Specified dose on specified days
  Other Names:

  • DARZALEX®
  • DARZALEX
  • FASPRO®
• Drug: Elotuzumab
  Specified dose on specified days
  Other Names:

  • Empliciti®
  • BMS-901608
• Drug: Carfilzomib
  Specified dose on specified days
  Other Name: KYPROLIS®
• Drug: Dexamethasone
  Specified dose on specified days

Study Arms

• Experimental: Arm A: Alnuctamab
  Intervention: Drug: Alnuctamab
• Active Comparator: Arm B: Standard of Care Regimens
  Interventions:

  • Drug: Pomalidomide
  • Drug: Daratumumab
  • Drug: Elotuzumab
  • Drug: Carfilzomib
  • Drug: Dexamethasone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: January 22, 2024): 466
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 21, 2030
• Estimated Primary Completion Date: November 16, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria

• Participant is willing and able to adhere to the study visit schedule and other protocol requirements including bone marrow aspirations and/or biopsies and hospitalization during the first cycle.

• Documented diagnosis of multiple myeloma (MM), and must:.

  i) Received at least 1 but not more than 3 prior lines of anti-myeloma therapy.

ii) Received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles).

iii) Achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy.

iv) Documented PD during or after their last anti-myeloma therapy or failure to achieve response.

• Must have measurable disease (as determined by central laboratory).
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at the time of the screening.

Exclusion Criteria

• Active, uncontrolled, or suspected infection.
• Known current, or history of, central nervous system involvement of multiple myeloma.
• History or presence of clinically relevant CNS pathology.
• Received prior BCMA-targeted TCE or BCMA-targeted CAR-T therapy.
• Previously received allogeneic stem cell transplantation at any time or received autologous stem cell transplantation within 3 months of initiating study intervention.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com; 855-907-3286; Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

• Listed Location Countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Korea, Republic of, Norway, Portugal, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States
• Removed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT06232707
• Other Study ID Numbers: CA058-1019; 2023-509472-42 ( Registry Identifier: EU Trial Number ); U1111-1281-8227 ( Registry Identifier: WHO )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: 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

• Current Responsible Party: Celgene
• Original Responsible Party: Same as current
• Current Study Sponsor: Celgene
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Celgene
• Verification Date: March 2024