West Cancer Center

MYELOMA: RELAPSED/REFRACTORY: 3rd Line or later: Abbvie M22-574

A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)

Title

Abbvie M22-574 (Myeloma 3rd Line etentamig)

Study Title

A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)

Site Link

NCT06158841

Malignancy

Multiple Myeloma

Stage

Stage 4

Disease Setting

Relapsed/Refractory

Line Of Therapy

3rd Line or later

Investigational Agent

Etentamig

Drug Class

Bispecific BCMA antibody

Jason Chandler, MD

Sponsor

Abbvie

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

DIagnosis of relapsed/refractory multiple myeloma during of after the patient's last treatment
ECOG PS 0-2
Must have measruable disease with at least 1 of the following assessed within 28 days of enrollment
- Serum M-protein >= 0.5g/dL
- Urine M-protein >= 200/24 hrs
- In patients without measurable serum or urine M protein, serum free light chain >= 100mg/L of the involved light chain and an abnormal serum kappa lambda ratio
Must have received at least 2 or more lines of therapy, including a proteasome inhibitor, an immunomodulatory imide (IMiD), and an anti-CD38 mAb
No clinically significant drug or alcohol abuse within last 6 months
No CNS involvement
No prior BCMA targeted therapy

Objective

Primary
- PFS
- ORR
Secondary
- OS
- Change in rate of VGPR or better
- Change in rate of CR or better
- Change in rate of MRD
- Physical functioning
- TTR
- DoR
- TTP
- TTNT
- EFS
- PRO
- QOL
- Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Multiple Myeloma

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes