A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma
Condition(s) studied
Investigational drug(s) / intervention(s)
Anitocabtagene Autoleucel: A single infusion of CAR+ transduced autologous T cells
Cyclophosphamide: Administered intravenously
Fludarabine: Administered intravenously
Pomalidomide: Tablet administered orally
Bortezomib: Administered intravenously or subcutaneously
Dexamethasone: Tablet administered orally
Daratumumab: Administered intravenously or subcutaneously
Carfilzomib: Administered intravenously
Study 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.
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) — Up to 4 years
PFS is defined as the time from randomization to disease progression per International Myeloma Working Group (IMWG) criteria as determined by independent review committee (IRC), or death due to any cause, whichever occurs first. - Minimal Residual Disease (MRD) Complete Response (CR) Rate at 9 Months — Up to 9 months
Minimal MRD is defined as the proportion of participants achieving CR/stringent CR (sCR) and MRD-negative status at 9 months. MRD negativity at 9 months is defined as negative MRD value at 9 months (± 3 months) in bone marrow assessment (\< 1 in 105 nucleated cells per IMWG criteria using NGS) (Kumar 2016). CR/sCR per IMWG criteria is determined by IRC.
Trial sites (117)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | |
| UCLA Hematology/Oncology (Bowyer Infusion Clinic) | Santa Monica | California | |
| Stanford Cancer Institute | Stanford | California | |
| Colorado Blood Cancer Institute | Denver | Colorado | |
| Sylvester Comprehensive Cancer Center | Coral Gables | Florida | |
| Mayo Clinic | Jacksonville | Florida | |
| Moffitt Cancer Center | Tampa | Florida | |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | |
| Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta | Newnan | Georgia | |
| St. Luke's Cancer Institute | Boise | Idaho | |
| University of Illinois Hospital and Health Sciences System | Chicago | Illinois | |
| IU Melvin and Bren Simon Comprehensive Cancer Center | Indianapolis | Indiana | |
| Norton Cancer Institute, St. Matthews Campus | Louisville | Kentucky | |
| Ochsner Clinical Foundation | New Orleans | Louisiana | |
| University of Maryland Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Boston Medical Center | Boston | Massachusetts | |
| University of Michigan | Ann Arbor | Michigan | |
| Corewell Health - Lemmen-Holton Cancer Pavilion | Grand Rapids | Michigan | |
| Mayo Clinic | Rochester | Minnesota | |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy | Omaha | Nebraska | |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | |
| New Mexico Cancer Research Alliance | Albuquerque | New Mexico | |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York | |
| Weill Cornell Medicine - New York Presbyterian Hosptial | New York | New York | |
| Icahn School of Medicine at Mount Sinai | New York | New York | |
| Levine Cancer Institute | Charlotte | North Carolina | |
| Novant Health Cancer Institute Hematology- Forsyth | Winston-Salem | North Carolina | |
| University of Cincinnati Cancer Center | Cincinnati | Ohio | |
| Oregon Health and Science University | Portland | Oregon | |
| University of Tennessee Medical Center | Knoxville | Tennessee | |
| Baptist Cancer Center | Memphis | Tennessee | |
| Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research | Nashville | Tennessee | |
| Henry-Joyce Cancer Clinic | Nashville | Tennessee | |
| St. David's South Austin Medical Center | Austin | Texas |
+ 77 more sites — see the full list on the official registry below.
On this site
📄 Darzalex (daratumumab) drug profile →Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06413498 on ClinicalTrials.gov ↗ ← All trials in Poland