This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    CA058-1019
Previous Study | Return to List | Next Study

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06232707
Recruitment Status : Not yet recruiting
First Posted : January 31, 2024
Last Update Posted : March 28, 2024
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Alnuctamab Drug: Pomalidomide Drug: Daratumumab Drug: Elotuzumab Drug: Carfilzomib Drug: Dexamethasone Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 466 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 29, 2024
Estimated Primary Completion Date : November 16, 2025
Estimated Study Completion Date : September 21, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Arm A: Alnuctamab Drug: Alnuctamab
Specified dose on specified days
Other Names:
  • BMS-986349
  • CC-93269
Active Comparator: Arm B: Standard of Care Regimens 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 5 years ]
  2. Overall response (OR) [ Time Frame: Up to 5 years ]
  3. Complete response (CR) or better [ Time Frame: Up to 5 years ]
  4. Very good partial response (VGPR) or better [ Time Frame: Up to 5 years ]
  5. Time to response (TTR) [ Time Frame: Up to 5 years ]
  6. Duration of response (DOR) [ Time Frame: Up to 5 years ]
  7. Time to progression (TTP) [ Time Frame: Up to 5 years ]
  8. Time to next treatment (TTNT) [ Time Frame: Up to 5 years ]
  9. Progression-free survival 2 (PFS2) [ Time Frame: Up to 5 years ]
  10. Restricted mean DOR (RMDOR) [ Time Frame: Up to 5 years ]
  11. Minimal residual disease (MRD) negativity rate [ Time Frame: Up to 5 years ]
  12. Incidence of adverse events (AEs) [ Time Frame: Up to 5 years ]
  13. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 5 years ]
  14. 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 ]
  15. Change from baseline in subscale scores of European quality of life multiple myeloma module (EORTC QLQ-MY20) [ Time Frame: Up to 5 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT06232707


Contacts
Layout table for location 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 #.

Locations
Show Show 166 study locations
Sponsors and Collaborators
Celgene
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT06232707    
Other Study ID Numbers: CA058-1019
2023-509472-42 ( Registry Identifier: EU Trial Number )
U1111-1281-8227 ( Registry Identifier: WHO )
First Posted: January 31, 2024    Key Record Dates
Last Update Posted: March 28, 2024
Last Verified: March 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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Relapsed or Refractory Multiple Myeloma
BMS-986349
CC-93269
RRMM
 Alnuctamab
CA058-1019
ALUMMINATE RRMM
Additional relevant MeSH terms:
Layout table for MeSH terms
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
Dexamethasone
 Daratumumab
Pomalidomide
Elotuzumab
Antibodies, Monoclonal
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents