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Multiple MyelomaPhase 3CARTITUDE-6NCT05257083

A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma

A Phase 3 study testing Daratumumab, Bortezomib and Lenalidomide in people with Multiple Myeloma, run by Stichting European Myeloma Network at 106 sites in 16 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 Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) 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?
Daratumumab, Bortezomib and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
759 participants
Where
106 sitesin 16 countries
Study dates
10 Oct 2023to Aug 2040
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

  • Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan.
  • Measurable disease, as assessed by central laboratory, at screening as defined by any of the following:
  • Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
  • Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
  • ECOG performance status of grade 0 or 1
  • Clinical laboratory values within prespecified range.

Who cannot join

  • Prior treatment with CAR-T therapy directed at any target.
  • Any prior BCMA target therapy.
  • Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids
  • Received a strong cytochrome P450 (CYP)3A4 inducer within 5 half-lives prior to randomization
  • Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization.
  • 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)

Trial locations and contacts

106 sites in 16 countries.

106 sites in 16 countries

United States27 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • University Of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Virginia

    Charlottesville, Virginia, 22903

  • University of Chicago

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Karmanos Cancer Center

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of Arkansas

    Little Rock, Arkansas, 72205

  • Medical College Wisconsin

    Milwaukee, Wisconsin, 53226

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • University of Rochester

    Rochester, New York, 14642

  • UC San Diego Health Moores Cancer Center

    San Diego, California, 92093

  • University of California San Francisco (UCSF)

    San Francisco, California, 94117

  • University of Washington Medical

    Seattle, Washington, 98195

  • Stanford University

    Stanford, California, 94305

  • Moffit Cancer Center

    Tampa, Florida, 33612

  • Montefiore M-E Center

    The Bronx, New York, 10467

Other trials in United States

Japan11 sites

  • Juntendo University Hospital

    Bunkyō City

  • Kyushu University Hospital - Hematology/Oncology

    Fukuoka

  • Hokkaido University Hospital-Department of Hematology

    Hokkaido

  • Hyogo College of Medicine

    Hyōgo

  • Kanazawa University Hospital

    Kanazawa

  • Nagoya City University Hospital - Department of Hematology & Oncology

    Nagoya

  • Okayama University Hospital - Hematology/Oncology

    Okayama

  • Osaka metropolitan university hospital

    Osaka

  • Japanese Red Cross Medical Center - Hematology

    Shibuya City

  • Keio University Hospital - Hematology

    Shinjuku-Ku

  • Tohoku University Hospital - Hematology

    Tōhoku

Other trials in Japan

Spain11 sites

  • Hospital Universitario Germans Trias i Pujol

    Badalona

  • Hospital Clinic de Barcelona

    Barcelona

  • Instituto Catalán de Oncología

    Barcelona

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital General Universitario Gregorio Marañón

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • CLINICA UNIV. DE NAVARRA, Pamplona

    Pamplona

  • Hospital Universitario de Salamanca

    Salamanca

  • Hospital de Santiago de Compostela

    Santiago de Compostela

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Universitario la Fe, Valencia

    Valencia

Other trials in Spain

Australia9 sites

  • Princess Alexandra Hospital

    Brisbane

  • Royal Prince Alfred Hospital

    Camperdown

  • Royal Brisbane and Womens Hospital

    Herston

  • Alfred Health

    Melbourne

  • Austin Hospital

    Melbourne

  • Peter MacCallum Cancer Centre

    Melbourne

  • Fiona Stanley Hospital

    Murdoch

  • Calvary Mater Newcastle Hospital

    Waratah

  • Westmead Hospital

    Westmead

Other trials in Australia

Canada8 sites

  • Cross Cancer Institute

    Edmonton

  • McMaster University

    Hamilton

  • Hopital Maisonneuve-Rosemont

    Montreal

  • Mcgill University Health Centre

    Montreal

  • Ottawa Hospital Research Institute

    Ottawa

  • (CHU) Centre Hospitalier Universitaire de Quebec Laval

    Québec

  • Princess Margaret Cancer Centre

    Toronto

  • Vancouver General Hospital

    Vancouver

Other trials in Canada

France6 sites

  • CHRU de Lille - Hopital Claude Huriez

    Lille

  • Hospices Civils De Lyon

    Lyon

  • CHU De Nantes - Hématologie Clinique

    Nantes

  • CHU Poitiers - Pôle régional de Cancérologie

    Poitiers

  • Hopital Saint Louis - Aphp Hôpitaux Universitaires Saint-Louis

    Saint-Louis

  • CHU de Toulouse

    Toulouse

Other trials in France

Germany5 sites

  • University Hospital of Cologne

    Cologne

  • Universitätsklinikum Hamburg - Eppendorf

    Hamburg

  • University Hospital of Leipzig

    Leipzig

  • Tübingen

    Tübingen

  • University Hospital of Würzburg

    Würzburg

Other trials in Germany

Netherlands5 sites

  • VU Medisch Centrum

    Amsterdam

  • University Medical Center Groningen

    Groningen

  • Radboud UMC

    Nijmegen

  • Erasmus MC

    Rotterdam

  • UMC Utrecht

    Utrecht

Other trials in Netherlands

Belgium4 sites

  • Jules Bordet Instituut

    Anderlecht

  • UZA

    Antwerp

  • UZ Gent

    Ghent

  • UZ Leuven

    Leuven

Other trials in Belgium

Czechia4 sites

  • Fakultni nemocnice Brno

    Brno

  • Fakultni nemocnice Hradec Kralove

    Králová

  • Fakutni nemocnice Ostrava

    Ostrava

  • Fakultni nemocnice Plzen

    Pilsen

Other trials in Czechia

Sweden4 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg

  • Landstinget i Ostergotland-Universitetssjukhuset i Linkoping

    Linköping

  • Skånes University Hospital Lund

    Lund

  • Akademiska Sjukhuset

    Uppsala

Other trials in Sweden

Switzerland4 sites

  • Universitaetsspital Basel - Zentrum fur Hamato-Onkologie

    Basel

  • Universitaetsspital Bern, Inselspital

    Bern

  • Centre Hospitalier Universitaire Vaudois (CHUV)Département d'oncologie

    Lausanne

  • Universitaetsspital Zuerich -Universitaeren Herzzentrum Zuerich

    Zurich

Other trials in Switzerland

Israel3 sites

  • Hadassah Medical Center

    Jerusalem

  • Sheba medical center

    Ramat Gan

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Greece2 sites

  • Attikon University General Hospital of Attica

    Athens

  • 'G. Papanikolaou' Hospital of Thessaloniki

    Thessaloniki

Other trials in Greece

United Kingdom2 sites

  • Queen Elizabeth Medical Centre

    Birmingham

  • University Hospital of Wales

    Cardiff

Other trials in United Kingdom

Norway1 site

  • Oslo University Hospital Ullevål - Oncology

    Oslo

Other trials in Norway

About this study

Official title: A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible

The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.

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) that is being evaluated to treat participants with multiple myeloma. The primary hypothesis is that in transplant-eligible participants with newly diagnosed multiple myeloma (NDMM), cilta-cel will significantly improve progression-free survival (PFS) and Sustained MRD-negative CR rate compared with Autologous Stem Cell Transplant (ASCT).

Approximately 750 participants (375 per arm) will be randomly assigned in a 1:1 ratio into 2 arms.

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

What participants receive

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

  • DaratumumabDrug

    Daratumumab will be administered SC.

  • BortezomibDrug

    Bortezomib will be administered SC.

  • LenalidomideDrug

    Lenalidomide will be administered orally.

  • DexamethasoneDrug

    Dexamethasone will be administered orally.

  • Cilta-celDrug

    Also called JNJ-68284528

    Cilta-cel will be administered intravenously

  • CyclophosphamideDrug

    Cyclophosphamide will be administered intravenously.

  • FludarabineDrug

    Fludarabine will be administered intravenously.

Study groups in NCT05257083
Study groupRoleWhat they receive
Arm A: DVRd + ASCT+DVRd (Standard Therapy)Active comparatorParticipants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) for 4 induction cycles. Followed by ASCT and 2 cycles of DVRd consolidation, and lenalidomide maintenance therapy for 2 years Daratumumab subcutaneously (SC), 1800 mg on days 1, 8, 15 and 22 of cycle 1 and 2, on days 1 and 15 of cycle 3-6. Bortezomib SC 1.3 mg/m^2 on days 1, 4, 8, and 11 of each cycle 1-6. Lenalidomide orally, 25 mg on days 1 to 21 of each cycle 1-6. Dexamethasone orally, 40 mg once a week on days 1, 8, 15 and 22 of each cycle 1-6. Each cycle will consist 28 days. Lenalidomide maintenance orally 10 to 15 mg on days 1 to 28 (continuously) until confirmed progressive disease or unacceptable toxicity or for a maximum of 2 years
Receives: Drug: Daratumumab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone
Arm B: DVRd followed by Ciltacabtagene AutoleucelExperimentalParticipants will receive daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) for 6 induction cycles. 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), followed by lenalidomide post CAR-T cell therapy for 2 years Daratumumab subcutaneously (SC), 1800 mg on days 1, 8, 15 and 22 of cycle 1 and 2, on days 1 and 15 of cycle 3-6. Bortezomib SC 1.3 mg/m^2 on days 1, 4, 8, and 11 of each cycle 1-6. Lenalidomide orally, 25 mg on days 1 to 21 of each cycle 1-6. Dexamethasone orally, 40 mg once a week on days 1, 8, 15 and 22 of each cycle 1-6. Each cycle will consist of 28 days. Lenalidomide maintenance orally 10 to 15 mg on days 1 to 28 (continuously) until confirmed progressive disease or unacceptable toxicity or for a maximum of 2 years
Receives: Drug: Daratumumab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone; 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 PD, as defined in the IMWG criteria, or death due to any cause, whichever occurs first

    Measured: up to 10 years ( or 300 PFS events)

  2. Sustained MRD-negative CR

    Sustained MRD-negative CR is defined as being MRD negative by bone marrow aspirate, as determined by NGS with a sensitivity of at least 10-5, and meeting the IMWG criteria for CR, and with MRD-negativity status confirmed at a minimum 12 months apart and without any examination showing MRD-positive status or PD in between.

    Measured: up to 24 months

Secondary outcomes (11)

  1. Overall Response (OR)

    OR is defined as participants who achieve a partial response (PR) or better according to the IMWG criteria.

    Measured: up to 17 years

  2. Complete Response (CR) or better status

    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 17 years

  3. Overall Minimal Residual Disease (MRD) -negative CR

    achieving MRD-negative CR, as determined by NGS at any time after the date of randomization before initiation of subsequent antimyeloma therapy.

    Measured: up to 17 years

  4. Time to subsequent antimyeloma 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 17 years

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

    the time from the date of randomization to the date of event, defined as PD as assessed by investigator that starts after the next line of subsequent therapy, or death due to any cause, whichever occurs first.

    Measured: up to 17 years

  6. Overall Survival (OS)

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

    Measured: up to 17 years

  7. 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: up to 17 years

  8. 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: up to 17 years

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

    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: up to 17 years

  10. 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: up to 17 years

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

    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 280 days

Timeline

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

  1. First posted25 Feb 2022
  2. Study start10 Oct 2023
  3. Primary completionJun 2033 (estimated)
  4. Study completionAug 2040 (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
759 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05257083
Sponsor's protocol ID
EMN28/68284528MMY3005
Other IDs
2021-003284-10
Acronym
CARTITUDE-6
Status last verified
Dec 2025
First submitted
16 Feb 2022
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daratumumab, Bortezomib and Lenalidomide in people with Multiple Myeloma, run by Stichting European Myeloma Network at 106 sites in 16 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 7 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 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Japan, Spain, Australia, Canada and 11 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 10 years ( or 300 PFS events)). The study lists 2 primary outcomes in all. 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 NCT05257083.

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 17 Mar 2026.

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CARTITUDE-6 Clinical Trial NCT05257083 | AzTrials