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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511188-26 | Other Identifier | European Medicines Agency | |
| jRCT2043240170 | Other Identifier | Japan Registry of Clinical Trials |
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| Name | Class |
|---|---|
| Arcellx, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anitocabtagene Autoleucel | Experimental | Participants with RRMM will receive lymphodepletion chemotherapy with cyclophosphamide and fludarabine for 3 days followed by single dose of anitocabtagene autoleucel chimeric antigen receptor positive (CAR+) on Day 1. |
|
| Standard of Care Therapy (SOCT) | Active Comparator | Participants will receive the investigator's choice of one of the following therapies:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anitocabtagene Autoleucel | Drug | A single infusion of CAR+ transduced autologous T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | 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. | Up to 4 years |
| Minimal Residual Disease (MRD) Complete Response (CR) Rate at 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. | Up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| CR Rate (CR/ Stringent Complete Response (sCR)) | CR rate is defined as the proportion of participants who achieved a best overall response of CR or sCR per IMWG criteria as determined by IRC. | Up to 4 years |
| Overall MRD Negativity |
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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 last dose of the last regimen
Measurable disease at screening per IMWG, defined as any of the following:
Only individuals who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this study
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Kite Study Director | Kite, A Gilead Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| Mayo Clinic Hospital |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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| Cyclophosphamide | Drug | Administered intravenously |
|
| Fludarabine | Drug | Administered intravenously |
|
| Pomalidomide | Drug | Tablet administered orally |
|
| Bortezomib | Drug | Administered intravenously or subcutaneously |
|
| Dexamethasone | Drug | Tablet administered orally |
|
| Daratumumab | Drug | Administered intravenously or subcutaneously |
|
| Carfilzomib | Drug | Administered intravenously |
|
Overall MRD negativity, defined as the proportion of any MRD negativity in participants with bone marrow aspirate (< 1 in 10^5 nucleated cells per IMWG criteria using next-generation sequencing (NGS)) at any time after randomization until disease progression, subsequent anti-multiple myeloma (MM) therapy, or death.
| Up to 7 years |
| Overall survival (OS) | OS is defined as the time from randomization to death due to any cause. | Up to 7 years |
| Overall Response Rate (ORR) | ORR is defined as the proportion of participants who achieve a best overall response of at least partial response (PR) or better (sCR, CR, very good partial response (VGPR), or PR) per IMWG criteria. | Up to 7 years |
| MRD-negative CR/sCR | MRD-negative CR/sCR is defined as the proportion of participants achieving MRD-negative CR/sCR until disease progression, subsequent anti-MM therapy, or death. | Up to 7 years |
| MRD-negative VGPR+ | MRD-negative VGPR+ is defined as the proportion of participants achieving MRD negativity and sCR/CR/VGPR until disease progression, subsequent anti-MM therapy, or death. | Up to 7 years |
| Sustained MRD Negativity | Sustained MRD negativity is defined as the proportion of participants remaining MRD-negative at the 10^-5 sensitivity threshold for the specified number of months starting from the first MRD-negative assessment date to the last MRD-negative assessment date prior to disease progression, subsequent anti-MM therapy, or death. Duration may include ≥ 12 months. Sustained MRD negativity will be evaluated for overall MRD negativity, MRD-negative CR/sCR, and MRD-negative VGPR+. | Up to 7 years |
| Duration of Response (DOR) | DOR is derived only among participants who experience an overall response (sCR, CR, VGPR, or PR) per IMWG criteria and is defined as the time from first overall response to disease progression per IMWG criteria, or death from any cause, whichever occurs first. | Up to 7 years |
| Time to Progression | Time to progression is defined as the time from randomization to the first documented disease progression per IMWG criteria, or death due to disease progression, whichever occurs first. | Up to 7 years |
| Time to Next Treatment | Time to next treatment is defined as the time from randomization to the start of subsequent anti-MM therapy or death from any cause, whichever occurs first. | Up to 7 years |
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | First dose up to 7 years |
| Percentage of Participants With Anti-Anitocabtagene Autoleucel CAR Antibodies (Anitocabtagene Autoleucel Arm) | Up to 7 years |
| Percentage of Participants With Presence of Replication-Competent Lentivirus (Anitocabtagene Autoleucel Arm) | Up to 7 years |
| Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score | The EORTC-QLQ-C30 is a multi-item questionnaire measuring the following content: five (5) multi-item functional scales, three (3) multi-item symptom scales, six (6) single item symptoms scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL). Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a high level of symptoms. | Up to 7 years |
| Change From Baseline in the EORTC - Multiple Myeloma Module (EORTC QLQ-MY20) Score | The EORTC QLQ-MY20 has 20 items across 4 independent subscales; 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment) with a recall period of one week. Scores from each subscale are transformed from 0 to 100. For the functional scales, high scores represent improvement. For the symptom scales, higher scores represent worsening. | Up to 7 years |
| Change From Baseline in the European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Score | The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS). The total score for EQ-5D-5L index is presented on a range where higher scores indicate better outcome. A positive change from Baseline indicates improvement. | Up to 7 years |
| Percentage of Participants Using Healthcare Resources | Healthcare resource utilization will be assessed based on the numbers of hospitalizations, intensive care unit (ICU) inpatient days, and non-ICU inpatient days. | Up to 7 years |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) | Duarte | California | 91010 | United States |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| UC San Diego Moores Cancer Center | San Diego | California | 92037 | United States |
| UCLA Hematology/Oncology (Bowyer Infusion Clinic) | Santa Monica | California | 90404 | United States |
| Stanford Cancer Institute | Stanford | California | 94305 | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| Sylvester Comprehensive Cancer Center | Coral Gables | Florida | 33146 | United States |
| Mayo Clinic | Jacksonville | Florida | 32256 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | United States |
| Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta | Newnan | Georgia | 30265 | United States |
| St. Luke's Cancer Institute | Boise | Idaho | 83712 | United States |
| University of Illinois Hospital and Health Sciences System | Chicago | Illinois | 60612 | United States |
| IU Melvin and Bren Simon Comprehensive Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Norton Cancer Institute, St. Matthews Campus | Louisville | Kentucky | 40207 | United States |
| Ochsner Clinical Foundation | New Orleans | Louisiana | 70121 | United States |
| University of Maryland Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Corewell Health - Lemmen-Holton Cancer Pavilion | Grand Rapids | Michigan | 49503 | United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy | Omaha | Nebraska | 68130 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| New Mexico Cancer Research Alliance | Albuquerque | New Mexico | 87102 | United States |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York | 10016 | United States |
| Weill Cornell Medicine - New York Presbyterian Hosptial | New York | New York | 10021 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Novant Health Cancer Institute Hematology- Forsyth | Winston-Salem | North Carolina | 27103 | United States |
| University of Cincinnati Cancer Center | Cincinnati | Ohio | 45219 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| Baptist Cancer Center | Memphis | Tennessee | 38104 | United States |
| Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research | Nashville | Tennessee | 37203 | United States |
| Henry-Joyce Cancer Clinic | Nashville | Tennessee | 37232 | United States |
| St. David's South Austin Medical Center | Austin | Texas | 78704 | United States |
| Houston Methodist Hospital Cancer Center | Houston | Texas | 77030 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute, University of Utah | Salt Lake City | Utah | 84112 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | NSW 2050 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Epworth HealthCare | Richmond | Victoria | 3121 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Ordensklinikum Linz GmbH Elisabethinen, Hamatologie mit Stammzelltransplantation, Hamostaseologie und medizinische Onkologie | Linz | Austria |
| Paracelsus Medizinischen Privatuniversitaet | Salzburg | A-5020 | Austria |
| University Hospital St. Poelten, Department of Internal Medicine I | Sankt Pölten | 3100 | Austria |
| Medical University of Vienna | Vienna | 1090 | Austria |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| University Hospital of Antwerp | Edegem | Belgium |
| UZ Leuven | Flemish Brabant | 3000 | Belgium |
| UZ Gent | Gent Oost-Vlaanderen | 9000 | Belgium |
| QEII Health Sciences Centre | Halifax | B3H 2Y9 | Canada |
| McGill University Health Center | Montreal | H4A 3J1 | Canada |
| The Ottawa Hospital - General Campus | Ottawa | K1H 8L6 | Canada |
| University Health Network - The Princess Margaret Cancer Centre | Toronto | M5G 2M9 | Canada |
| Fakultni Nemocnice Ostrava | Severomoravsky KRAJ | 708 52 | Czechia |
| CHU de Lille- Hopital Claude Huriez | Lille | 59037 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| CHU De Montpellier - Hopital Saint Eloi | Montpellier | 34080 | France |
| Centre Hospitalier Universitaire de Nantes | Nantes | 44093 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Hopital Saint Antoine | Paris | 75571 | France |
| Hôpital Lyon Sud | Pierre-Bénite | 69495 | France |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | 86021 | France |
| CHU de Rennes | Rennes | 59037 | France |
| CHU de Toulouse. IUCT Oncopole | Toulouse | 31100 | France |
| Charité - Universitätsmedizin Berlin | Berlin | 12203 | Germany |
| Universitatsklinikum Koln, Klinik I fOr lnnere Medizin | Cologne | Germany |
| Universitätsklinikum Essen | Essen | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Universitatsklinikum Hamburg Eppendorf | Hamburg | 20246 | Germany |
| Universitatsklinikum Leipzig | Leipzig | 4103 | Germany |
| TUM Klinikum, Rechts der Isar, Klinik und Poliklinik fur Innere Medizin III, Hamatologie und Onkologie | München | 80333 | Germany |
| Universitatsklinikum Wurzburg | Tübingen | 72076 | Germany |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | MI | 20133 | Italy |
| IRCCS AOU di Bologna | Bologna | 40138 | Italy |
| Ospedale San Raffaele | Milan | 3302 | Italy |
| Policlinico Universitario Argostino Gemelli | Roma | 00168 | Italy |
| AOU Città della Salute e della Scienza Presidio Ospedaliero Molinette | Torino | 10126 | Italy |
| Hyogo Medical University Hospital | Hyōgo | 663-8501 | Japan |
| Nagoya City University Hospital | Nagoya | 467-8602 | Japan |
| The University of Osaka Hospital | Osaka | 565-0871 | Japan |
| Jichi Medical University Hospital | Tochigi | 329-0498 | Japan |
| Juntendo University School of Medicine Juntendo Clinic | Tokyo | 113-8431 | Japan |
| Japanese Red Cross Medical Center | Tokyo | 150-8935 | Japan |
| Amsterdam UMC - Location vUmc | Amsterdam | 1081 HV | Netherlands |
| University Medical Center Groningen | Groningen | 9700 RB | Netherlands |
| Erasmus Medical Center | Rotterdam | 3015GD | Netherlands |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | 60-569 | Poland |
| Warszawa-Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego | Warsaw | 02-097 | Poland |
| Instytut Hematologii i Transfuzjologii | Warsaw | 02-776 | Poland |
| ICO Badalona-H.U. Germans Trias i Pujol | Badalona | 08916 | Spain |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Duran i Reynals | Barcelona | 08908 | Spain |
| Hospital Clinico Universitario Virgen de la Arrixaca | El Palmar | 30120 | Spain |
| Hospital Universitario Ramon Y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Clinica Universidad de Navarra | Pamplona | 31008 | Spain |
| Complejo Asistencial Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | 39008 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Inselspital - Universitätsspital Bern | Bern | 3010 | Switzerland |
| University Hospitals Bristol NHS Foundation Trust, Bristol Haematology and Oncology Centre | Bristol | BS2 8ED | United Kingdom |
| University Hospital of Wales | Cardiff | CF14 4XW | United Kingdom |
| Leeds Teaching Hospitals NHS Trust, St James's University Hospital | Leeds | LS9 7TF | United Kingdom |
| King's College Hospital | London | SE5 9NU | United Kingdom |
| University College London Hospital | London | WC1E 6JN | United Kingdom |
| Newcastle Hospitals NHS Foundation Trust, Freeman Hospital | Newcastle | NE7 7DN | United Kingdom |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| C467566 | pomalidomide |
| D000069286 | Bortezomib |
| D003907 | Dexamethasone |
| C556306 | daratumumab |
| C524865 | carfilzomib |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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