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NCT04181827Active, not recruitingPhase 3

A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma

A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA, Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects With Relapsed and Lenalidomide-Refractory Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to compare the efficacy of ciltacabtagene autoleucel (cilta-cel) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
419 (actual)
First submitted
27 Nov 2019
Start date
12 Jun 2020
Primary completion date
1 May 2024
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT04181827
EU CT number
2023-506588-32-00
EudraCT number
2019-001413-16

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 419
  • From 12 Jun 2020 to the primary completion date, 1 May 2024
  • 85 sites in 16 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy directed at any target
  • Any previous therapy that is targeted to B-cell maturation antigen (BCMA)
  • Ongoing toxicity from previous anticancer therapy that has not resolved to baseline levels or to Grade 1 or less; except for alopecia
  • Participants with Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral neuropathy will not be permitted to receive pomalidomide, bortezomib, and dexamethasone (PVd) as standard therapy or bridging therapy; however, participants may receive daratumumab, pomalidomide, and dexamethasone (DPd) as standard therapy or bridging therapy
  • Received a cumulative dose of corticosteroids equivalent to \>=70 mg of prednisone within the 7 days prior to randomization
  • Monoclonal antibody treatment within 21 days
  • Cytotoxic therapy within 14 days
  • Proteasome inhibitor therapy within 14 days
  • Immunomodulatory drug (IMiD) therapy within 7 days

Who the study is looking for

  • Measurable disease at screening as defined by any of the following: (a) Serum monoclonal paraprotein (M-protein) level greater than or equal to (\>=) 0.5 gram per deciliter (g/dL) or urine M-protein level \>=200 milligram (mg)/24 hours; or (b) Light chain multiple myeloma without measurable M-protein in the serum or the urine: Serum free light chain \>=10 mg/dL and abnormal serum free light chain ratio
  • Have received 1 to 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD)
  • Have documented evidence of PD by International Myeloma Working Group (IMWG) criteria based on investigator's determination on or within 6 months of their last regimen
  • Be refractory to lenalidomide per IMWG consensus guidelines (failure to achieve minimal response or progression on or within 60 days of completing lenalidomide therapy). Progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion. For participants with more than 1 prior line of therapy, there is no requirement to be lenalidomide refractory to the most recent line of prior therapy. However, participants must be refractory to lenalidomide in at least one prior line
  • Have clinical laboratory values meeting the following criteria during the Screening Phase (re testing is allowed but the below criteria must be met in the latest test prior to randomization):
    • Hemoglobin \>=8 gram per deciliter (g/dL) (without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted);
    • Absolute neutrophil count (ANC) \>=1 \* 10\^9 per liter (L) (without recombinant human granulocyte colony-stimulating factor \[G-CSF\] within 7 days and without pegylated G-CSF within 14 days of the laboratory test);
    • Platelet count \>=75 \* 10\^9/L (without prior platelet transfusion within 7 days before the laboratory test) in participants in whom less than (\<) 50 percent (%) of bone marrow nucleated cells are plasma cells; platelet count \>=50 \* 10\^9/L (without prior platelet transfusion within 7 days before the laboratory test) in participants in whom \>=50% of bone marrow nucleated cells are plasma cells;
    • Lymphocyte count \>=0.3 \* 10\^9/L;
    • Aspartate aminotransferase (AST) less than or equal to (\<=)3 \* upper limit of normal (ULN);
    • Alanine aminotransferase (ALT) \<=3 \* ULN;
    • Total bilirubin \<=2.0 \* ULN; except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin \<=1.5 \* ULN is required);
    • Estimated glomerular filtration rate \>=40 milliliter per minute (mL/min) per 1.73 meter square (m\^2) (to be calculated using the Modification of Diet in Renal Disease \[MDRD\] formula)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (85)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Adelaide Hospital
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AdelaideAustraliaUnknown status
Royal Prince Alfred Hospital
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CamperdownAustraliaUnknown status
Royal Brisbane and Womens Hospital
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HerstonAustraliaUnknown status
Peter MacCallum Cancer Centre
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MelbourneAustraliaUnknown status
Alfred Health
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MelbourneAustraliaUnknown status
Fiona Stanley Hospital
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MurdochAustraliaUnknown status
Antwerp University Hospital
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EdegemBelgiumActive, not recruiting
Universiteit Gent
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GentBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
CHU de Liège
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LiègeBelgiumActive, not recruiting
University Hospital Cologne AöR
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CologneGermanyActive, not recruiting
Technische Universität Dresden
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DresdenGermanyActive, not recruiting
Universitaet Leipzig
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LeipzigGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyActive, not recruiting
Rigshospitalet
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Copenhagen OeDenmarkActive, not recruiting
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceActive, not recruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceActive, not recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceActive, not recruiting
Queen Elizabeth Hospital
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BirminghamUnited KingdomUnknown status
Bristol Haematology and Oncology Centre
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BristolUnited KingdomUnknown status
University Hospital Wales
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CardiffUnited KingdomUnknown status
University College Hospital
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LondonUnited KingdomUnknown status
Kings College Hospital
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LondonUnited KingdomUnknown status
Christie Hospital
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ManchesterUnited KingdomUnknown status
Freeman Hospital
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Newcastle upon TyneUnited KingdomUnknown status
University General Hospital Attikon
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AthensGreeceCompleted
Hadassah University Hospita Ein Kerem
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JerusalemIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Sourasky Medical Center
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Tel AvivIsraelUnknown status
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyActive, not recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyActive, not recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyActive, not recruiting
Kyushu University Hospital
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FukuokaJapanUnknown status
Kanazawa University Hospital
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KanazawaJapanUnknown status
University Hospital Kyoto Prefectural University of Medicine
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KyotoJapanUnknown status
Nagoya City University Hospital
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NagoyaJapanUnknown status
Okayama University Hospital
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OkayamaJapanUnknown status
Hokkaido University Hospital
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SapporoJapanUnknown status
Tohoku University Hospital
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SendaiJapanUnknown status
Japanese Red Cross Medical Center
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Shibuya CityJapanUnknown status
The Catholic University of Korea Seoul St Marys Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Amsterdam UMC
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AmsterdamNetherlandsActive, not recruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsActive, not recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsActive, not recruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsActive, not recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
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GliwicePolandActive, not recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandActive, not recruiting
Instytut Hematologii I Transfuzjologii
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WarsawPolandActive, not recruiting
Region Skane Skanes Universitetssjukhus
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LundSwedenActive, not recruiting
Uppsala University Hospital
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UppsalaSwedenActive, not recruiting
University of Maryland Medical Center
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BaltimoreUnited StatesUnknown status
University of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
The Ohio State University
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ColumbusUnited StatesUnknown status
Colorado Blood Cancer Institute
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DenverUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Hackensack University Medical Center
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HackensackUnited StatesUnknown status
University of Iowa Hospitals and Clinics
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Iowa CityUnited StatesUnknown status
Wisconsin Institutes for Medical Research
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MadisonUnited StatesUnknown status
University Of Miami Leonard M Mille School Of Medicine SCCC
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MiamiUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
Yale New Haven Hospital
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New HavenUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Mayo Clinic Cancer Center-Scottsdale
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PhoenixUnited StatesUnknown status
University of Rochester Medical Center
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RochesterUnited StatesUnknown status
Mayo Clinic - Rochester
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RochesterUnited StatesUnknown status
Huntsman Cancer Institute
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Salt Lake CityUnited StatesUnknown status
Stanford University Medical Center
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StanfordUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
University of Kansas
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WestwoodUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.