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

NCT04181827 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 4 other identifiers: CR10869568284528MMY30022019-001413-162023-506588-32-00
• Study Type: interventional
• Target: 419
• Locations: 16 countries
• Sites: 88

Brief Summary

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).

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS: defined as time from date of randomization to date of first documented progressed disease (PD) as per International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first. PD: increase of 25% from lowest response value: serum and urine M-component (absolute increase must be \>=0.5 grams per deciliter \[g/dL\] and \>=200 milligrams \[mg\] per 24 hours, respectively); only in participants without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase of \>10 mg/dL); only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell (PC)% (absolute increase of \>=10%), appearance of new lesion; definite development of new bone lesions or definite increase in size of existing bone lesions, \>=50% increase in circulating PCs (minimum of 200 cells per microliter \[uL\]) if this was only measure of disease.

  From randomization (Day 1) to either progressive disease or death, whichever occurred first (up to 3.9 years)

Secondary Outcomes (19)

• Percentage of Participants Who Achieved Complete Response (CR) or Stringent Complete Response (sCR)

  From randomization (Day 1) up to 7 years

• Percentage of Participants Who Achieved Overall Minimal Residual Disease (MRD) Negative Status (at 10^-5)

  From randomization (Day 1) up to 7 years

• Percentage of Participants Who Were in CR or sCR and Achieved MRD-negative Status at 12 Months +/-3 Months

  From randomization (Day 1) up to 12 months +/- 3 months

• Percentage of Participants Who Achieved Sustained MRD-negative Status

  From randomization (Day 1) up to 7 years

• Overall Survival (OS)

  From randomization (Day 1) up to 7 years

Study Arms (2)

Arm A: PVd or DPd (Standard Therapy)

EXPERIMENTAL

Participants will receive either PVd or DPd as a standard therapy. In PVd treatment, participants will receive oral pomalidomide 4 mg on Days 1 to 14 in each cycle; bortezomib 1.3 mg/meter square (m\^2) SC on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each cycle will consist of 21 days. In DPd treatment, participants will receive daratumumab SC 1800 mg weekly on Days 1, 8, 15, and 22 (Cycles 1 and 2), every 2 weeks on Days 1 and 15 (Cycles 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); oral pomalidomide 4 mg on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg oral or IV weekly on Days 1, 8, 15, and 22 (Cycle 1 onwards). Each cycle will consist of 28 days. Participants will continue to receive PVd or DPd until confirmed PD, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs earlier.

Drug: Pomalidomide; Drug: Bortezomib; Drug: Dexamethasone; Drug: Daratumumab

Arm B: (Ciltacabtagene Autoleucel [Cilta-cel])

EXPERIMENTAL

Participants will receive at least one cycle of bridging therapy (PVd or DPd) and additional cycles of bridging therapy may be considered based on participant's clinical status and timing of availability of cilta-cel along with conditioning regimen (cyclophosphamide 300 milligram \[mg\]/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).

Drug: Cilta-cel

Interventions

Cilta-cel DRUG

Cilta-cel infusion will be administered at a target dose of 0.75 \* 10\^6 CAR-positive viable T cells/kilogram (kg).

Arm B: (Ciltacabtagene Autoleucel [Cilta-cel])

Pomalidomide DRUG

Pomalidomide 4 mg will be administered orally.

Arm A: PVd or DPd (Standard Therapy)

Bortezomib DRUG

Bortezomib 1.3 milligram per meter square (mg/m\^2) will be administered subcutaneously (SC).

Arm A: PVd or DPd (Standard Therapy)

Dexamethasone DRUG

Dexamethasone 20 mg/day (10mg/day for participants \>75 years of age) (on bortezomib treatment days and the days following bortezomib treatment) will be administered orally in PVd treatment; and orally or intravenous (IV) at 40 mg weekly (20mg weekly for participants \>75 years of age) in DPd treatment.

Arm A: PVd or DPd (Standard Therapy)

Daratumumab DRUG

Daratumumab 1800 mg will be administered SC.

Arm A: PVd or DPd (Standard Therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (88)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Mayo Clinic Cancer Center-Scottsdale

Phoenix, Arizona, 85054, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5623, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

University Of Miami Leonard M Mille School Of Medicine SCCC

Miami, Florida, 33136, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas

Westwood, Kansas, 66205, United States

Location

University Of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Wisconsin Institutes for Medical Research

Madison, Wisconsin, 53705, United States

Location

Medical College Of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

Royal Prince Alfred Hospital

Camperdown, 2050, Australia

Location

Royal Brisbane and Womens Hospital

Herston, 4029, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, 3000, Australia

Location

Alfred Health

Melbourne, 3004, Australia

Location

Fiona Stanley Hospital

Murdoch, 6150, Australia

Location

Universitair Ziekenhuis - Antwerpen

Antwerp, 2650, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

Liège, B-4000, Belgium

Location

Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

CHRU de Lille Hopital Claude Huriez

Lille, 59037, France

Location

Hospices Civils de Lyon HCL

Lyon, 69002, France

Location

CHU de Montpellier Hopital Saint Eloi

Montpellier, 34295, France

Location

C.H.U. Hotel Dieu - France

Nantes, 44093, France

Location

Hopital Saint Louis

Paris, 75475, France

Location

CHU De Poitiers

Poitiers, 86021, France

Location

Institut Universitaire du cancer de Toulouse-Oncopole

Toulouse, 31059, France

Location

Universitaetsklinikum Koeln

Cologne, 50924, Germany

Location

Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden

Dresden, 01307, Germany

Location

Universitaetsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

Location

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

Tübingen, 72076, Germany

Location

Universitatsklinikum Wurzburg

Würzburg, 97080, Germany

Location

Attikon University General Hospital of Attica

Athens, 12462, Greece

Location

Hadassah University Hospita Ein Kerem

Jerusalem, P.O.B. 12000, Israel

Location

Sheba Medical Center

Ramat Gan, 74047, Israel

Location

Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

Bologna, 40138, Italy

Location

IRCCS Ospedale San Raffaele HSR

Milan, 20132, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

Turin, 10126, Italy

Location

Kyushu University Hospital

Fukuoka, 812 8582, Japan

Location

Kanazawa University Hospital

Kanazawa, 920 8641, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Nagoya City University Hospital

Nagoya, 467 8602, Japan

Location

Okayama University Hospital

Okayama, 700 8558, Japan

Location

Hokkaido University Hospital

Sapporo, 060-8648, Japan

Location

Tohoku University Hospital

Sendai, 980 8574, Japan

Location

Japanese Red Cross Medical Center

Shibuya City, 150-8935, Japan

Location

VU Medisch Centrum

Amsterdam, 1081 HV, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Erasmus MC

Rotterdam, 3015 CN, Netherlands

Location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80 214, Poland

Location

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

Gliwice, 44102, Poland

Location

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, 60-569, Poland

Location

Instytut Hematologii i Transfuzjologii

Warsaw, 02 776, Poland

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591, South Korea

Location

Inst. Cat. D'Oncologia-Badalona

Badalona, 08916, Spain

Location

Hosp Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

Location

Hosp. Virgen Del Rocio

Seville, 41013, Spain

Location

Skane University Hospital

Lund, 221 85, Sweden

Location

Karolinska Universitetssjukhuset Huddinge, Hematologiska Kliniken, Huddinge

Stockholm, 141 86, Sweden

Location

Akademiska Sjukhuset

Uppsala, 751 85, Sweden

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, BS2 8ED, United Kingdom

Location

University Hospital Wales

Cardiff, CF14 4XW, United Kingdom

Location

University College Hospital

London, NW1 2BU, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (8)

• Lopez-Munoz N, Bar N, Diels J, van Sanden S, Mendes J, Lee S, Hernando T, Lendvai N, Patel N, Ishida T, Er J, Harrison SJ. Ciltacabtagene Autoleucel Versus Idecabtagene Vicleucel in Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma with 2-4 Prior Lines of Therapy: Updated Matching-Adjusted Indirect Comparison. Adv Ther. 2026 Mar;43(3):1327-1340. doi: 10.1007/s12325-025-03479-y. Epub 2026 Feb 2.

  PMID: 41627370 DERIVED

• Einsele H, San-Miguel J, Dhakal B, Touzeau C, Leleu X, van de Donk NW, Sidana S, Oriol A, Cohen YC, Harrison SJ, Mateos MV, Martinez-Lopez J, Corradini P, Karlin L, Chen D, Li Q, Yeh TM, Li K, Plaks V, Slaughter A, Lonardi C, Benachour N, Ghosh A, Vogel M, Schecter JM, Lendvai N, Koneru M, Patel N, Florendo E, Ho PJ, Popat R. Cilta-cel in lenalidomide-refractory multiple myeloma (CARTITUDE-4): an updated analysis including overall survival from an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2026 Feb;27(2):254-268. doi: 10.1016/S1470-2045(25)00653-9. Epub 2026 Jan 7.

  PMID: 41519141 DERIVED

• Touzeau C, Lipe B, Khan AM, Dhakal B, Nair S, He J, Mendes J, Lee S, Lonardi C, Slaughter A, Lendvai N, Schecter JM, Chen D, Zhao M, Yeh TM, Leleu X, Puig N, Dytfeld D, Zamagni E, Weisel K, Karlin L, Delforge M, Corradini P, Mina R, Roeloffzen W, Sidana S. Comparative Effectiveness of Ciltacabtagene Autoleucel in CARTITUDE-4 Versus Real-World Physician's Choice of Therapy from the Flatiron Registry in Lenalidomide-Refractory Multiple Myeloma. Adv Ther. 2025 Oct;42(10):5023-5041. doi: 10.1007/s12325-025-03308-2. Epub 2025 Aug 6.

  PMID: 40768190 DERIVED

• Fonseca R, Diels J, Ghilotti F, Mendes J, Van Hoorenbeeck S, Lee S, Schecter JM, Lendvai N, Patel N, Triguero A, Alsdorf W, van de Donk NWCJ, Ursi M. Survival Outcomes with Cilta-cel Versus Conventional Treatment Regimens for Patients with Lenalidomide-Refractory Multiple Myeloma Using Inverse Probability of Treatment Weighting. Adv Ther. 2025 Sep;42(9):4418-4431. doi: 10.1007/s12325-025-03278-5. Epub 2025 Jul 4.

  PMID: 40613875 DERIVED

• Harrison SJ, Touzeau C, Kint N, Li K, Nguyen T, Mayeur-Rousse C, Rahman M, Le Bris Y, Er J, Eugene-Lamer J, Haynes NM, Li J, Abbott RC, Bodet-Milin C, Moreau A, Letouze E, Lendvai N, Schecter JM, Deraedt W, Banerjee A, Lengil T, Vogel M, Foulk B, Zhao H, Smirnov D, Slaughter A, Lonardi C, Lee E, Marquez L, Sankari A, Plaks V, Filho JOC, Patel N, Geng D, Gastinne T, Kelly H, Tiong IS, Eveillard M, Chevallier P, Lade S, Moreau P, Grimmond S, Oliaro J, Tessoulin B, Blombery P. CAR+ T-Cell Lymphoma after Cilta-cel Therapy for Relapsed or Refractory Myeloma. N Engl J Med. 2025 Feb 13;392(7):677-685. doi: 10.1056/NEJMoa2309728.

  PMID: 39938094 DERIVED

• Mina R, Mylin AK, Yokoyama H, Magen H, Alsdorf W, Minnema MC, Shune L, Isufi I, Harrison SJ, Shah UA, Schecter JM, Vogel M, Lendvai N, Gries KS, Katz EG, Slaughter A, Lonardi C, Gilbert J, Li Q, Deraedt W, Filho OC, Patel N, Florendo E, Karlin L, Weisel K. Patient-reported outcomes following ciltacabtagene autoleucel or standard of care in patients with lenalidomide-refractory multiple myeloma (CARTITUDE-4): results from a randomised, open-label, phase 3 trial. Lancet Haematol. 2025 Jan;12(1):e45-e56. doi: 10.1016/S2352-3026(24)00320-X.

  PMID: 39756844 DERIVED

• San-Miguel J, Dhakal B, Patel N, Schecter JM, Lendvai N, Einsele H. Plain language summary of the CARTITUDE-4 study of ciltacabtagene autoleucel for the treatment of people with relapsed or refractory multiple myeloma. Future Oncol. 2024;20(33):2509-2520. doi: 10.1080/14796694.2024.2376973. Epub 2024 Aug 7.

  PMID: 39110421 DERIVED

• San-Miguel J, Dhakal B, Yong K, Spencer A, Anguille S, Mateos MV, Fernandez de Larrea C, Martinez-Lopez J, Moreau P, Touzeau C, Leleu X, Avivi I, Cavo M, Ishida T, Kim SJ, Roeloffzen W, van de Donk NWCJ, Dytfeld D, Sidana S, Costa LJ, Oriol A, Popat R, Khan AM, Cohen YC, Ho PJ, Griffin J, Lendvai N, Lonardi C, Slaughter A, Schecter JM, Jackson CC, Connors K, Li K, Zudaire E, Chen D, Gilbert J, Yeh TM, Nagle S, Florendo E, Pacaud L, Patel N, Harrison SJ, Einsele H. Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. N Engl J Med. 2023 Jul 27;389(4):335-347. doi: 10.1056/NEJMoa2303379. Epub 2023 Jun 5.

  PMID: 37272512 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

pomalidomide; Bortezomib; Dexamethasone; daratumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Executive Medical Director Oncology
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 2, 2019
• Study Start: June 12, 2020
• Primary Completion: May 1, 2024
• Study Completion (Estimated): April 9, 2029
• Last Updated: May 11, 2026
• Results First Posted: May 20, 2025

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

IL (3); DK (1); FR (7); DE (6); AU (6); GB (7); SE (3); IT (5); ES (7); KR (3); US (19); NL (4); PL (4); GR (1); JP (8); BE (4)