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

Celgene170 sites in 7 countriesMay 3, 2024

ConditionsMultiple Myeloma

InterventionsCarfilzomib Dexamethasone Pomalidomide Daratumumab Elotuzumab Alnuctamab

DrugsAlnuctamab Pomalidomide Daratumumab Elotuzumab Carfilzomib Dexamethasone

Overview

Phase: Phase 3
Intervention: Carfilzomib
Conditions: Multiple Myeloma
Sponsor: Celgene
Locations: 170
Primary Endpoint: Progression-free Survival (PFS)
Status: Withdrawn
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

May 3, 2024

End Date

September 21, 2030

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Celgene

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Arm B: Standard of Care Regimens

Intervention: Carfilzomib

Arm B: Standard of Care Regimens

Intervention: Dexamethasone

Arm B: Standard of Care Regimens

Intervention: Pomalidomide

Arm B: Standard of Care Regimens

Intervention: Daratumumab

Arm B: Standard of Care Regimens

Intervention: Elotuzumab

Arm A: Alnuctamab

Intervention: Alnuctamab

Outcomes

Primary Outcomes

Progression-free Survival (PFS)

Time Frame: Up to 5 years

Secondary Outcomes

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