Clinical trial NCT04662255: Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)
Official title: A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Lymphoma, Mantle-Cell
Keywords: Bruton's Tyrosine Kinase Inhibitor
BTKi
Hematologic Disease
Lymphoma, non-Hodgkin's
Lymphoma, B-Cell
Lymphoma
pirtobrutinib
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2020-12-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.

Detailed description: This is a Phase 3 global, randomized, open-label study comparing pirtobrutinib (Arm A) to investigator's choice of ibrutinib, acalabrutinib or zanubrutinib (Arm B) in MCL patients who have received 1 or more lines of therapy and are BTK inhibitor naïve.

Eligibility criteria: Inclusion Criteria:

* Confirmed MCL diagnosis
* Previously treated with at least one prior line of systemic therapy for MCL
* Measurable disease per Lugano criteria
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Absolute neutrophil count ≥ 0.75 × 109/L without granulocyte-colony stimulating factor support within 7 days of screening
* Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors within 7 days of screening
* Platelets ≥ 50 × 109/L not requiring transfusion support or growth factors within 7 days of screening.
* AST and ALT ≤ 3.0 x upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 x ULN.
* Creatinine clearance of ≥ 30 mL/min according to Cockcroft/Gault Formula

Exclusion Criteria:

* Prior treatment with an approved or investigational BTK inhibitor
* History of bleeding diathesis
* History of stroke or intracranial hemorrhage within 6 months of randomization
* History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified T-cell (CAR-T) therapy within 60 days of randomization
* Clinically significant cardiovascular disease
* Prolonged QT interval corrected using Fridericia's formula (QTcF) \> 470 ms on 2/3 consecutive ECGs, and mean QTcF\>470 ms on all 3 ECGs
* Known HIV infection or active HBV, HCV, or CMV infections. (Certain participants with controlled HBV infections may still be eligible)
* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption
* Ongoing chronic treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment.
* Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
* Vaccination with live vaccine within 28 days prior to randomization

Primary outcomes:
measure: To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL)
timeFrame: Up to approximately 24 months
Secondary outcomes:
measure: To compare Event Free Survival (EFS) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
timeFrame: Up to approximately 24 months
measure: To compare Time to Treatment Failure (TTTF) as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
timeFrame: Up to approximately 24 months
measure: Time to worsening (TTW) of MCL-related symptoms
timeFrame: Up to approximately 24 months
measure: Comparative Tolerability as measured by proportion of time with high side effect burden
timeFrame: Up to approximately 24 months
measure: To compare Overall Response Rate (ORR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
timeFrame: Up to approximately 24 months
measure: To compare Duration of Response (DOR) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
timeFrame: Up to approximately 24 months
measure: To compare Overall Survival of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology, LLC
state: Alaska
city: Phoenix
country: United States
facility: Arizona Oncology Associates, P.C. - HOPE
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Denver
country: United States
facility: USO-Rocky Mountain Cancer Center
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Tamarac
country: United States
facility: Oncology-Hematology Associates of West Broward
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists East
state: Florida
city: Lexington
country: United States
facility: University of Kentucky Markey Cancer Center
state: Kentucky
city: Paducah
country: United States
facility: Mercy Health-Paducah Medical Oncology and Hematology
state: Kentucky
city: New Orleans
country: United States
facility: Tulane Cancer Center Office of Clinical Research
state: Louisiana
city: Baltimore
country: United States
facility: Greenebaum Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: DFCI Lymphoma
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University Medical School
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Asheville
country: United States
facility: Messino Cancer Center
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care Inc
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute & Research Ctr.
state: Oregon
city: Nashville
country: United States
facility: Sarah Cannon Research Institute SCRI
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology-Austin Midtown
state: Texas
city: Bedford
country: United States
facility: Texas Oncology - Bedford
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: McAllen
country: United States
facility: Texas Oncology - McAllen
state: Texas
city: Sherman
country: United States
facility: Texas Oncology - Sherman
state: Texas
city: The Woodlands
country: United States
facility: US Oncology
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Fairfax
country: United States
facility: USO-Virginia Cancer Specialists, PC
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital
state: Wisconsin
city: Kogarah
country: Australia
facility: The St. George Hospital
state: New South Wales
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Auchenflower
country: Australia
facility: Icon Cancer Care - The Wesley Medical Centre
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
state: Oberösterreich
city: Salzburg
country: Austria
facility: Uniklinikum Salzburg
state: Osterreich
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: Oost-Vlaanderen
city: Roeselare
country: Belgium
facility: AZ Delta
state: West Flanders
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
city: Rio de Janeiro
country: Brazil
facility: Hospital São Lucas Copacabana
state: CEP
city: São Paulo
country: Brazil
facility: Hospital Beneficência Portuguesa de São Paulo
state: CEP
city: Aldeota
country: Brazil
facility: Centro de Oncologia e Hematologia do Ceará LTDA
state: Fortaliza
city: Goiânia
country: Brazil
facility: Hospital das Clínicas da UFGo - Goiânia
state: Goiás
city: São Luís
country: Brazil
facility: Hospital Sao Domingos
state: MA
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer - INCA
state: Rio De Jan
city: Campinas
country: Brazil
facility: Centro de Pesquisa Clínica São Lucas
state: Sau Paulo
city: Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto, Dept. CIP - Centro Integrado de Pesquisa
state: SP
city: Pacaembu
country: Brazil
facility: Instituto de Ensino e Pesquisas São Lucas - IEP Hemomed
state: São Paulo
city: Santo André
country: Brazil
facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
state: São Paulo
city: Sao Paulo
country: Brazil
facility: A. C. Camargo Cancer Center
state: São Paulo
city: Curitiba- PR
country: Brazil
facility: HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná
city: Sao Paulo
country: Brazil
facility: Hospital da Clinicas da Faculdade de Medicina da USP
city: Sao Paulo
country: Brazil
facility: Hospital 9 De Julho
city: São Paulo
country: Brazil
facility: IPITEC
city: São Paulo
country: Brazil
facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer Vancouver
state: British Columbia
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing ChaoYang Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospial
state: Fujian
city: Guangzhou
country: China
facility: Cancer Center of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
state: Guangdong
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Urumqi
country: China
facility: Affiliated Tumor Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Lishui
country: China
facility: Lishui Central Hospital
state: Zhejiang
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Tianjin
country: China
facility: Blood Institute of the Chinese Academy of Medical science
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
state: Hradec Králové
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital, Aarhus Sygehus
state: Jutland
city: Odense C
country: Denmark
facility: Odense Universitetshospital
state: Syd
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
state: Aquitaine
city: Paris
country: France
facility: Hopital de la Pitie Salpetriere
state: Cedex 13
city: Vandœuvre-lès-Nancy
country: France
facility: Chu De Nancy Hop D'Adultes De Brabois
state: Meurthe-et-Moselle
city: Lille
country: France
facility: Hôpital Saint Vincent-de-Paul
state: Nord-Pas-de-Calais
city: Rouen
country: France
facility: Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
state: Seine-Maritime
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
city: Paris
country: France
facility: Institut Curie
city: Pessac Cedex
country: France
facility: Centre hospitalier universitaire de Haut Leveque
city: Pierre Benite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Politiers
country: France
facility: Pole Regionalde Cancérologie(CHU de Poitiers)
city: Tours Cedex
country: France
facility: CHRU De Tours
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
state: Baden-Württemberg
city: Würzburg
country: Germany
facility: Klinikum der Universität München Großhadern
state: Bayern
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH
state: Hessen
city: Münster
country: Germany
facility: Universitätsklinikum Münster - Albert Schweitzer Campus
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: InVO Institut für Versorgungsforschung in der Onkologie
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: Universitätsmedizin Johannes Gutenberg Universität Mainz
state: Rheinland-Pfalz
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: OncoResearch Lerchenfeld GmbH
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Alessandria
country: Italy
facility: Presidio Ospedaliero Civile Santi Antonio e Biagio
state: AL
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
state: Emilia-Romagna
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci
state: Emilia-Romagna
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombardia
city: Bologna
country: Italy
facility: IRCCS - AOU di Bologna
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Palermo
country: Italy
facility: Ospedale Vincenzo Cervello
city: Potenza
country: Italy
facility: Irccs Crob
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Varese
country: Italy
facility: Ospedale Di Circolo E Fondazione Macchi
city: Nagoya
country: Japan
facility: Nagoya Medical Center
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Osaka Sayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Kawagoe
country: Japan
facility: Saitama Medical Center
state: Saitama
city: Koto
country: Japan
facility: Japanese Foundation for Cancer Research
state: Tokyo
city: Hiroshima
country: Japan
facility: Chugoku Central Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kyoto
country: Japan
facility: Kyoto Furitsu Medical University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Namdong-gu
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Incheon-gwangyeoksi [Incheon]
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Korea
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
state: Seogu
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Bergen op Zoom
country: Netherlands
facility: Bravis Ziekenhuis
state: Noord-Brabant
city: Den Haag
country: Netherlands
facility: Ziekenhuisapotheek HagaZiekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Addington
country: New Zealand
facility: Christchurch Hospital
state: Christchurch
city: Auckland
country: New Zealand
facility: Middlemore Clinical Trials
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej
state: Lubelskie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Krakow
country: Poland
facility: Pratia MCM Krakow
city: Skorzewo
country: Poland
facility: AIDPORT Sp. z o.o.
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny Klinika
city: Łódź
country: Poland
facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii
city: Lisboa
country: Portugal
facility: IPOFG - Lisboa
city: Lisboa
country: Portugal
facility: Champalimaud Foundation
city: Moscow
country: Russian Federation
facility: GUZ of Moscow City Clinical Hospital n.a. S.P. Botkin
city: Saint Petersburg
country: Russian Federation
facility: Fed. State Budgetary Institution "Russian Scientific & Research Institute of Hemat. & Transfusiology of Fed. Medico-Bio. Agency
city: Saint-Petersburg
country: Russian Federation
facility: State Medical University named after I.P. Pavlov
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Andalucía
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Hospitalet De Llobregat
country: Spain
facility: Hospital Duran I Reynals
state: Barcelona
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Palma De Mallorca(Baleares)
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Luzern 16
country: Switzerland
facility: Kantonsspital Luzern
state: Luzern
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital
state: Taipei
city: Chiayi County
country: Taiwan
facility: Chang Gung Memorial Hospital - Chiayi
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng-Kung Uni. Hosp.
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Aberdeen City
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: Devon
city: Newmarket
country: United Kingdom
facility: GenesisCare
state: Suffolk
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Nottingham
country: United Kingdom
facility: City Hospital, Nottingham University Hospitals
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Windsor
country: United Kingdom
facility: GenesisCare, Windsor
Study officials:
affiliation: Loxo Oncology, Inc.
name: Patient Advocacy
role: STUDY_DIRECTOR
References:
citation: Eyre TA, Shah NN, Dreyling M, Jurczak W, Wang Y, Cheah CY, Song Y, Gandhi M, Chay C, Sharman J, Andorsky DJ, Messersmith HM, Ruppert AS, Muthig VA, Ito R, Wang ML. BRUIN MCL-321: phase III study of pirtobrutinib versus investigator choice of BTK inhibitor in BTK inhibitor naive mantle cell lymphoma. Future Oncol. 2022 Nov;18(36):3961-3969. doi: 10.2217/fon-2022-0976. Epub 2022 Nov 15.
citation: Ito R, Eyre TA, Shah NN, Gouill SL, Dreyling M, Vandenberghe E, Jurczak W, Wang Y, Cheah CY, Gandhi M, Chay C, Sharman J, Andorsky DJ, Song Y, Stark A, Muthig V, Wang ML. MCL-135 BRUIN MCL-321, a Phase 3 Open-Label, Randomized Study of Pirtobrutinib Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated, BTK Inhibitor Naive Mantle Cell Lymphoma (Trial in Progress). Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S395-S396. doi: 10.1016/S2152-2650(22)01570-1.