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

Phase 3

Withdrawn

• Conditions: Multiple Myeloma
• Interventions: Drug: Alnuctamab; Drug: Pomalidomide; Drug: Daratumumab; Drug: Elotuzumab; Drug: Carfilzomib; Drug: Dexamethasone

• Registration Number: NCT06232707
• Lead Sponsor: Celgene

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 available

Study Timeline

• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-31
• Status Verified: 2024-05
• Study Start: 2024-05-03
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31
• Primary Completion: 2025-11-16
• Study Completion: 2030-09-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Alnuctamab	Alnuctamab	-
Arm B: Standard of Care Regimens	Daratumumab	-
Arm B: Standard of Care Regimens	Pomalidomide	-
Arm B: Standard of Care Regimens	Elotuzumab	-
Arm B: Standard of Care Regimens	Carfilzomib	-
Arm B: Standard of Care Regimens	Dexamethasone	-

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Progression-free survival 2 (PFS2)	Up to 5 years
Overall Survival (OS)	Up to 5 years
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
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
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

Trial Locations

Locations (170)

Local Institution - 0151; 🇺🇸 Birmingham, Alabama, United States

Local Institution - 0088; 🇺🇸 Los Angeles, California, United States

Local Institution - 0358; 🇺🇸 Stanford, California, United States

Local Institution - 0355; 🇺🇸 New Haven, Connecticut, United States

Local Institution - 0434; 🇺🇸 Washington, District of Columbia, United States

Local Institution - 0433; 🇺🇸 Wichita, Kansas, United States

Local Institution - 0439; 🇺🇸 Saint Matthews, Kentucky, United States

Local Institution - 0323; 🇺🇸 New Orleans, Louisiana, United States

Local Institution - 0324; 🇺🇸 Baltimore, Maryland, United States

Local Institution - 0441; 🇺🇸 Bethesda, Maryland, United States

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