AzTrials
AzTrials

Multiple MyelomaPhase 3CARTITUDE-5NCT04923893

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy

A Phase 3 study testing Bortezomib, Dexamethasone and Lenalidomide in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 136 sites in 26 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Bortezomib, Dexamethasone and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
743 participants
Where
136 sitesin 26 countries
Study dates
19 Aug 2021to 22 Sep 2036
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=)1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours; or Light chain MM in whom only measurable disease is by serum free light chain (FLC) levels: Serum immunoglobin (Ig) free light chain >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa/lambda FLC ratio
  • Eastern Cooperative Oncology Group Performance Status grade of 0 or 1
  • Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) due to: Ineligible due to advanced age; or Ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or Deferral of high-dose chemotherapy with ASCT as initial treatment
  • A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive serum or urine pregnancy tests (beta-human chorionic gonadotropin) prior to starting Bortezomib, Lenalidomide and Dexamethasone (VRd) and must agree to further testing during the study.
  • Clinical laboratory values meeting the following criteria during the screening phase: hemoglobin greater than or equal to (>=) 8.0 g/dL (>=5 millimoles per liter [mmol/L]), recombinant human erythropoietin use is permitted; platelets >=75 *10^9/L; absolute lymphocyte count >=0.3 *10^9/L; absolute neutrophil count (ANC) >=1.0 ×10^9/L (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to (<=) 3.0 * upper limit of normal (ULN); estimated glomerular filtration rate >=40 milliliter per minute/1.73 meter square (mL/min/1.73 m^2) based upon modified diet in renal disease formula (MDRD-4) calculation or a 24-hour urine collection; total bilirubin <=2.0 * ULN; except in participants with congenital hyperbilirubinemia, such as Gilbert syndrome (in which case direct bilirubin <=2.0 * ULN is required)

Who cannot join

  • Frailty index of >=2 according to Myeloma Geriatric Assessment score
  • Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5
  • Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
  • Stroke or seizure within 6 months of signing Informed Consent Form (ICF)
  • Seropositive for human immunodeficiency virus (HIV)
  • Vaccinated with live, attenuated vaccine within 4 weeks prior to first dose of VRd
Show all 11Show fewer
  • Participant must not require continuous supplemental oxygen
  • Hepatitis B infection
  • Hepatitis C infection
  • Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
  • Any therapy that is targeted to B-cell maturation antigen (BCMA)

Trial locations and contacts

136 sites in 26 countries.

136 sites in 26 countries

United States19 sites

  • University Of Maryland Medical Center

    Baltimore, Maryland, 21201-1595

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Cancer Institute

    Detroit, Michigan, 48202-2608

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Kentucky

    Lexington, Kentucky, 40536-0293

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • University of Miami Health System

    Miami, Florida, 33136

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Yale Cancer Center

    New Haven, Connecticut, 06510

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • New York Presbyterian-Weill Cornell Medical College

    New York, New York, 10065

  • AdventHealth Cancer Institute

    Orlando, Florida, 32832

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • UCSF

    San Francisco, California, 94143

Other trials in United States

Germany11 sites

  • Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

    Berlin, 12203

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Universitaetsklinikum Hamburg Eppendorf

    Hamburg, 20246

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

  • Universitatsmedizin der Johannes Gutenberg Universitat Mainz

    Mainz, 55131

  • Klinikum Grosshadern Der Ludwig-Maximilians-Universitat

    München, 81377

  • Universitaetsklinikum Regensburg

    Regensburg, 93053

  • Klinikum der Eberhard Karls Universitaet Abt fur innere Med II Haematologie Onkologie Germany

    Tübingen, 72076

  • Universitatsklinikum Wurzburg

    Würzburg, 97080

Other trials in Germany

Spain11 sites

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08041

  • Hosp Univ Vall D Hebron

    Barcelona, 8035

  • Instituto Catalan Deoncologia Hospital Duran I Reynals

    L'Hospitalet de Llobregat, 08908

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. Virgen de La Arrixaca

    Murcia, 30120

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

Other trials in Spain

Japan10 sites

  • Juntendo University Hospital

    Bunkyō City, 113 8431

  • Kyushu University Hospital

    Fukuoka, 812 8582

  • Hyogo Medical University Hospital

    Hyôgo, 663-8501

  • Kanazawa University Hospital

    Kanazawa, 920 8641

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Nagoya City University Hospital

    Nagoya, 467 8602

  • Okayama University Hospital

    Okayama, 700 8558

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Tohoku University Hospital

    Sendai, 980 8574

  • Japanese Red Cross Medical Center

    Shibuya City, 150-8935

Other trials in Japan

Australia9 sites

  • Royal Prince Alfred Hospital

    Camperdown, 2050

  • St Vincents Hospital Melbourne

    Fitzroy, 3065

  • Austin Health

    Heidelberg, 3084

  • Royal Brisbane and Womens Hospital

    Herston, 4029

  • Alfred Health

    Melbourne, 3004

  • Peter MacCallum Cancer Centre

    Melbourne, 8006

  • Fiona Stanley Hospital

    Murdoch, 6150

  • Calvary Mater Newcastle Hospital

    Waratah, 2298

  • Western Sydney Local Health District

    Westmead, 2145

Other trials in Australia

United Kingdom7 sites

  • University Hospitals Birmingham NHS Trust,

    Birmingham, B15 2TH

  • Bristol Royal Infirmary

    Bristol, BS2 8BJ

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF

  • University College Hospital

    London, NW1 2BU

  • Kings College Hospital

    London, SE5 9RS

  • Manchester Royal Infirmary

    Manchester, M13 9WL

  • The Royal Marsden NHS Trust Sutton

    Surrey, SM2 5PT

Other trials in United Kingdom

Poland6 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach

    Gliwice, 44102

  • Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

    Lublin, 20 090

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60 569

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02 776

  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50 367

Other trials in Poland

South Korea6 sites

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

Belgium5 sites

  • Universitair Ziekenhuis - Antwerpen

    Antwerp, 2650

  • AZ St.-Jan Brugge-Oostende AV

    Bruges, 8000

  • UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

    Liège, B-4000

Other trials in Belgium

Canada5 sites

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V5C2

  • Hopital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G2M9

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

France5 sites

  • Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

    Lille, 59000

  • C.H.U. Hotel Dieu - France

    Nantes, 44093

  • Hopital Saint Louis

    Paris, 75475

  • CHU Poitiers - Hopital la Miletrie

    Poitiers, 86021

  • Institut Universitaire du cancer de Toulouse-Oncopole

    Toulouse, 31059

Other trials in France

Austria4 sites

  • Medizinische Universitat Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie

    Graz, 8036

  • Krankenhaus der Elisabethinen Linz

    Linz, 4020

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020

  • Medical University of Vienna Universitatsklinik fur Innere Medizin I

    Vienna, 1090

Other trials in Austria

Czechia4 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni Nemocnice Ostrava

    Ostrava - Poruba, 708 52

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Netherlands4 sites

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • University Medical Center Groningen

    Groningen, 9713 GZ

  • UMC Radboud

    Nijmegen, 6500 HB

  • Erasmus MC

    Rotterdam, 3075 EA

Other trials in Netherlands

Argentina3 sites

  • Hospital Aleman

    Buenos Aires, C1118AAT

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABD

  • Hospital Privado Universitario De Cordoba

    Córdoba, 5016

Other trials in Argentina

Brazil3 sites

  • IDOR - Regional Bahia

    Salvador, 41253-190

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05651-901

Other trials in Brazil

Denmark3 sites

  • Aarhus University Hospital

    Aarhus N, 8200

  • Rigshospitalet

    Copenhagen, 2100

  • Odense Universitetshospital

    Odense C, 5000

Other trials in Denmark

Finland3 sites

  • Helsinki University Hospital

    Helsinki, 00290

  • Oulu University Hospital

    Oulu, 90220

  • Turku University Hospital

    Turku, 20520

Other trials in Finland

Greece3 sites

  • Alexandra General Hospital of Athens

    Athens, 11528

  • Attikon University General Hospital of Attica

    Athens, 12462

  • G.Papanikolaou

    Thessaloniki, 57010

Other trials in Greece

Israel3 sites

  • Hadassah University Hospita Ein Kerem

    Jerusalem, P.O.B. 120

  • Sheba Medical Center Tel Hashomer

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Sweden3 sites

  • Sahlgrenska University Hospital

    Gothenburg, 413 45

  • Universitetssjukhuset

    Linköping, 58185

  • Skane University Hospital

    Lund, 221 85

Other trials in Sweden

Switzerland3 sites

  • Universitatsspital Basel

    Basel, 4031

  • Inselspital Universitatsspital Bern

    Bern, 3010

  • Kantonsspital St Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

Hungary2 sites

  • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely

    Budapest, 1097

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

Other trials in Hungary

Portugal2 sites

  • Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. 1

    Lisbon, 1099-023

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.

    Porto, 4200072

Other trials in Portugal

Ireland1 site

  • St James Hospital

    Dublin, D08 NHY1

Other trials in Ireland

Norway1 site

  • Oslo universitetssykehus HF, Rikshospitalet

    Oslo, 0372

Other trials in Norway

About this study

Official title: A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).

Read the detailed description

Multiple myeloma (MM) is a malignant plasma cell disorder characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function. JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. The primary hypothesis of this study is that in participants with newly diagnosed MM, treatment with VRd induction followed by a single administration of cilta-cel will significantly improve progression free survival compared to Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by Rd maintenance. The study will screen participants with newly diagnosed MM who are not planned to receive autologous stem cell transplant (ASCT) as initial therapy. This study will be conducted in 4 phases: Screening (up to 28 days), Pre-randomization Treatment, Treatment, and Follow-up. Assessments like patient-reported outcome(s) (PROs), electrocardiogram (ECG), vital signs and pharmacokinetics will be performed during the study. Safety evaluations will include review of adverse events, laboratory test results, vital sign measurements, physical examination findings, assessment of cardiac function, Immune-Effector Cell-Associated Encephalopathy (ICE) and handwriting assessments (only for Arm B) and Eastern Cooperative Oncology Group (ECOG) performance status. Safety data will be periodically reviewed by an Independent Data Monitoring Committee (IDMC). The duration of the study is approximately 12 years 5 months.

Keywords
Newly Diagnosed Multiple Myeloma, Cellular Therapy, CAR-T Therapy, BCMA CAR-T
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BortezomibDrug

    Bortezomib will be administered SC.

  • DexamethasoneDrug

    Dexamethasone will be administered orally.

  • LenalidomideDrug

    Lenalidomide will be administered orally.

  • Cilta-celDrug

    Also called JNJ-68284528

    Cilta-cel infusion will be administered.

  • CyclophosphamideDrug

    Cyclophosphamide will be administered intravenously.

  • FludarabineDrug

    Fludarabine will be administered intravenously.

Study groups in NCT04923893
Study groupRoleWhat they receive
Arm A: VRd+Rd (Standard Therapy)ExperimentalParticipants will receive bortezomib, lenalidomide, and dexamethasone (VRd) regimen for 6 cycles before randomization. Following randomization, participants in Arm A will receive 2 more cycles of VRd. In VRd treatment, participants will receive bortezomib 1.3 milligram per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8 and 11 of each cycle (Cycles 1 to 8), oral lenalidomide 25 mg on Days 1 to 14 of each cycle (Cycles 1 to 8) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle (Cycles 1 to 8). Each cycle will consist of 21 days. After 8 cycles of VRd, treatment will continue with lenalidomide and dexamethasone (Rd) maintenance therapy. In Rd treatment, participants will receive oral lenalidomide 25 mg on Days 1 to 21 of each cycle and oral dexamethasone 40 mg on Days 1, 8, 15, and 22 of each cycle. Each cycle will consist of 28 days. Participants will continue to receive Rd until confirmed progressive disease or unacceptable toxicity.
Receives: Drug: Bortezomib; Drug: Dexamethasone; Drug: Lenalidomide
Arm B: VRd+Ciltacabtagene Autoleucel (Cilta-cel)ExperimentalParticipants will receive VRd regimen for 6 cycles before randomization. Following randomization, participants in Arm B will undergo apheresis and receive two more cycles of VRd as bridging therapy. In VRd treatment, participants will receive bortezomib 1.3 mg/m^2 SC on Days 1, 4, 8 and 11 of each cycle for Cycles 1 to 8; oral lenalidomide 25 mg on days 1 to 14 of each cycle for Cycles 1 to 8 and oral dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle for Cycles 1 to 8. Each cycle will consist of 21 days. After 8 cycles of VRd, participants will receive a conditioning regimen (cyclophosphamide 300 mg/m^2 intravenous [IV] and fludarabine 30 mg/m^2 IV daily for 3 days) and Cilta-cel infusion 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells/kilogram (kg).
Receives: Drug: Bortezomib; Drug: Dexamethasone; Drug: Lenalidomide; Drug: Cilta-cel; Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    Progression-free survival is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD), as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first.

    Measured: Up to 4 years and 5 months

Secondary outcomes (20)

  1. Sustained Minimal Residual Disease (MRD) Negative CR

    Sustained MRD negative complete response (CR) as determined by next generation sequencing (NGS) with sensitivity of 10^-5, and defined by MRD negative CR plus at least 12 months durability of the MRD negative CR status.

    Measured: Up to 12 years and 5 months

  2. MRD Negative CR at 9 Months

    MRD negative CR rate at 9 months is defined as the percentage of participants who achieve MRD negative CR status at 9±3 months after the randomization date.

    Measured: 9 months

  3. Overall MRD Negative CR

    Overall MRD negative is defined as the percentage of participants who achieve MRD negativity at any time after the date of randomization before initiation of subsequent therapy.

    Measured: Up to 12 years and 5 months

  4. Overall Survival (OS)

    Overall survival is measured from the date of randomization to the date of the participant's death.

    Measured: Up to 12 years and 5 months

  5. Complete Response or Better

    CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response according to the IMWG criteria.

    Measured: Up to 12 years and 5 months

  6. Time to Subsequent Anti-myeloma Therapy

    Time to subsequent anti-myeloma therapy is defined as the time from randomization to the start of subsequent anti-myeloma therapy.

    Measured: Up to 12 years and 5 months

  7. Progression Free Survival on Next-line Therapy (PFS2)

    PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as PD as assessed by investigator that starts after the next line of subsequent therapy, or death from any cause, whichever occurs first.

    Measured: Up to 12 years and 5 months

  8. Number of Participants with Adverse Events (AEs), Abnormalities in Laboratory Parameters, 12-Lead Electrocardiogram (ECG), Physical Examination, and Vital Signs

    Number of participants with AEs, abnormalities in laboratory parameters (complete blood count [CBC] with differential, coagulation, chimeric antigen receptor T cell [CAR-T] chemistry, full metabolic panel etc.), 12-lead ECG, physical examination, and vital signs will be reported.

    Measured: Up to 12 years and 5 months

  9. Arm B: Systemic Cytokine Concentrations

    Serum or plasma proteomic profiling of cytokines (such as interleukin [IL] 6, IL-15, and IL 10) concentrations will be measured for biomarker assessment.

    Measured: Up to Day 112

  10. Arm B: Levels of Chimeric Antigen Receptor T cell (CAR-T) Cell Activation Markers

    CAR-T cell activation markers including, but not limited to, CD4+, CD8+, CD25+, central memory, effector memory cells will be reported. An evaluation of cell populations may be performed by flow cytometry, cytometry by time of flight (CyTOF), single cell RNA sequencing (scRNAseq) or similar technologies and be correlated with response.

    Measured: Up to 12 years and 5 months

  11. Arm B: Levels of Soluble B-cell Maturation Antigen (BCMA)

    Levels of soluble BCMA will be reported.

    Measured: Up to 1 year

  12. Arm B: Levels of Cilta-cel Expansion (proliferation), and Persistence

    Levels of cilta-cel expansion (proliferation), and persistence via monitoring CAR-T positive cell counts and CAR transgene level will be reported.

    Measured: Up to 12 years and 5 months

  13. Arm B: Number of Participants with Anti-cilta-cel Antibodies

    Number of participants with anti-cilta-cel antibodies will be reported.

    Measured: Up to 12 years and 5 months

  14. Arm B: Number of Participants with Presence of Replication Competent Lentivirus

    Number of participants with presence of replication competent lentivirus will be reported.

    Measured: Up to 12 years and 5 months

  15. Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score

    The EORTC QLQ-C30 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.

    Measured: Baseline up to 12 years and 5 months

  16. Change from Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Score

    The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items with recall period of "7 days" and responses are reported on a 5-point verbal rating scale. Item responses are scored from 0 to 4. Higher scores indicate greater severity/impact.

    Measured: Baseline up to 12 years and 5 months

  17. Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score

    The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems, where Level 1: no problem, Level 2: slight problems, Level 3: moderate problems, Level 4: severe problems and Level 5: extreme problems, plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

    Measured: Baseline up to 12 years and 5 months

  18. Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score

    The PGIS uses 2 items to assess the participant's perception of the severity of their disease symptoms and impact using a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).

    Measured: Baseline up to 12 years and 5 months

  19. Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Items

    The National Cancer Institute's PRO-CTCAE is an item library of common adverse events experienced by people with cancer that are appropriate for self-reporting. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference that ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact.

    Measured: Up to 161 days

  20. Time to Worsening of Symptoms, Functioning and Overall Well-being

    Time to worsening is measured as the interval from the date of randomization to the start date of worsening in MySIm-Q symptom, impact, or total scores.

    Measured: Up to 12 year and 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2021
  2. Study start19 Aug 2021
  3. Primary completion14 Feb 2029 (estimated)
  4. Study completion22 Sep 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
743 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04923893
Sponsor's protocol ID
CR109015
Other IDs
68284528MMY3004, 2021-001242-35, 2023-505850-16-00, 2023
Acronym
CARTITUDE-5
Status last verified
Nov 2026
First submitted
10 Jun 2021
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bortezomib, Dexamethasone and Lenalidomide in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 136 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 136 sites in United States, Germany, Spain, Japan, Australia and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Up to 4 years and 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04923893.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in