A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma

Kite, A Gilead Company

Summary

The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug. The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM.

Description

After completing the treatment period, all participants who will receive anitocabtagene autoleucel, will be followed in the post-treatment follow-up period. Thereafter, participants will transition to a separate long-term follow-up study (KT-US-982-5968) to continue follow-up out to 15 years.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Key Inclusion Criteria: * Documented historical diagnosis of multiple myeloma (MM) * Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatory drug (IMiD) and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb). A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy. * Documented evidence of progressive disease by IMWG criteria based on the investigator's determination on or within 12 months of the la…

Interventions

Drug
Anitocabtagene Autoleucel
A single infusion of CAR+ transduced autologous T cells
Drug
Cyclophosphamide
Administered intravenously
Drug
Fludarabine
Administered intravenously
Drug
Pomalidomide
Tablet administered orally
Drug
Bortezomib
Administered intravenously or subcutaneously
Drug
Dexamethasone
Tablet administered orally
Drug
Daratumumab
Administered intravenously or subcutaneously

Locations (124)

Banner MD Anderson Cancer Center
Gilbert, Arizona
Mayo Clinic Hospital
Gilbert, Arizona
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California
University of California Davis Comprehensive Cancer Center
Sacramento, California
UC San Diego Moores Cancer Center
San Diego, California