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Multiple MyelomaPhase 2CARTITUDE-10NCT07149857

A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel

A Phase 2 study testing Cilta-cel, Cyclophosphamide and Induction therapy in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 20 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate how well (efficacy) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Cilta-cel, Cyclophosphamide and Induction therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
20 sitesin 3 countries
Study dates
3 Oct 2025to 6 Apr 2029
Phase
Phase 2
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented diagnosis of newly diagnosed multiple myeloma (NDMM) according to the most recent international myeloma working group (IMWG) diagnostic criteria and measurable disease at diagnosis (prior to start of any anti-myeloma therapy): Serum monoclonal paraprotein (M-protein) level greater than equal to (>=)1.0 grams per deciliter (g/dL) or urine M-protein level >= 200 milligrams (mg)/24 hours; or light chain multiple myeloma in whom the only measurable disease is by serum free light chain (FLC) levels in the serum: involved serum free light chain >= 10 mg/dL and abnormal serum free light chain ratio
  • Not considered a candidate for high-dose chemotherapy with stem cell transplantation due to: (a) Advanced age; or (b) Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with stem cell transplantation; or (c) Participant refusal of high-dose chemotherapy with stem cell transplantation as initial treatment
  • Participant must have received at least 3 cycles and no more than 5 cycles of induction therapy. Initially, only participants receiving triplet induction therapy with DRd or VRd will be enrolled. Only after sponsor notification, participants receiving quadruplet DVRd induction therapy may be enrolled (screening can commence as early as during Cycle 3 of induction). Participants must have achieved >= partial response (PR) on the most recent disease assessment to be enrolled
  • Eastern cooperative oncology group (ECOG) Performance Status score of 0 or 1
  • Must be willing and able to adhere to the lifestyle restrictions specified in the protocol

Who cannot join

  • Frailty index of >= 2 according to Myeloma Geriatric Assessment score
  • Known allergies, hypersensitivity, or intolerance to study intervention or its active agents
  • Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib
  • Participants who require continuous supplemental oxygen

Trial locations and contacts

20 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

20 sites in 3 countries

Spain8 sites, 8 recruiting

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

    Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

    Recruiting

  • Hosp. Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Recruiting

  • Clinica Univ. de Navarra

    Pamplona, 31008

    Recruiting

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

    Recruiting

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

    Recruiting

  • Hosp. Virgen Del Rocio

    Seville, 41013

    Recruiting

Other trials in Spain

United States7 sites, 3 recruiting

  • Atrium Health

    Charlotte, North Carolina, 28204

    Active, not recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Recruiting

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

    Active, not recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Active, not recruiting

  • University of California San Francisco

    San Francisco, California, 94143

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Active, not recruiting

  • Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157

    Recruiting

Other trials in United States

Australia5 sites, 5 recruiting

  • Royal Prince Alfred Hospital

    Camperdown, 2050

    Recruiting

  • Monash Medical Centre

    Clayton, 3168

    Recruiting

  • Austin Hospital

    Heidelberg, 3084

    Recruiting

  • Fiona Stanley Hospital

    Murdoch, 6150

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, 4102

    Recruiting

Other trials in Australia

About this study

Official title: A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel

The purpose of this study is to evaluate how well (efficacy) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion following a cyclophosphamide and fludarabine lymphodepletion regimen.

Being tested
Cilta-cel, Cyclophosphamide, Induction therapy, Fludarabine
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Cilta-celDrug

    Also called JNJ-68284528

    Cilta-cel will be administered as intravenous infusion.

  • CyclophosphamideDrug

    Cyclophosphamide will be administered as intravenous infusion.

  • Induction therapyDrug

    Induction therapy consist of bortezomib, lenalidomide, and dexamethasone (VRd) or daratumumab, lenalidomide, and dexamethasone (DRd) or daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd), will will be administered.

  • FludarabineDrug

    Fludarabine will be administered as intravenous infusion.

Study groups in NCT07149857
Study groupRoleWhat they receive
Cohort AExperimentalParticipants will undergo apheresis and continue to receive 1-2 more cycles of the induction regimen (DRd, VRd or DVRd regimen, in accordance with institution standard of care, and is not considered study treatment) that they were receiving prior to screening. After completion of induction therapy, participants will receive a conditioning regimen of cyclophosphamide daily for 3 days, followed by cilta-cel IV infusion on Day 1. Participants will later enter the post-treatment phase, which will start on Day 113 and last until end of study or cohort completion.
Receives: Drug: Cilta-cel; Drug: Cyclophosphamide; Drug: Induction therapy
Cohort BExperimentalParticipants will undergo apheresis and continue to receive 1-2 more cycles of the induction regimen (DRd, VRd or DVRd regimen, in accordance with institution standard of care, and is not considered study treatment) that they were receiving prior to screening. After completion of induction therapy, participants will receive a conditioning regimen of cyclophosphamide and fludarabine daily for 3 days, followed by Ciltacel IV infusion on Day 1. Participants will later enter the post-treatment phase, which will start on Day 113 and last until end of study or cohort completion.
Receives: Drug: Cilta-cel; Drug: Cyclophosphamide; Drug: Induction therapy; Drug: Fludarabine

What is being measured

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

  1. Minimal Residual Disease (MRD)-negative Complete Response (CR) After Cilta-cel Infusion

    Participants in CR or better who achieve MRD-negative status at 12 months after cilta-cel infusion with a sensitivity of 10^-5, prior to progressive disease (PD) or subsequent anti-myeloma therapy will be reported.

    Measured: At least 12 months after Cilta-cel infusion on Day 1

Secondary outcomes (9)

  1. Overall MRD-negative CR Rate

    Overall MRD-negative CR is defined as the percentage of participants who achieve MRD-negative CR with a sensitivity of 10^-5 at any time after enrollment but prior to PD or subsequent anti-myeloma therapy.

    Measured: From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months)

  2. CR or better status

    CR or better is defined as the percentage of participants who achieve a CR or stringent complete response (sCR) according to the most recent international myeloma working group (IMWG) criteria.

    Measured: From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months)

  3. Progression Free Survival (PFS)

    PFS is defined as the time from the date of enrollment to the date of first documented PD, as defined in the most recent IMWG criteria, or death due to any cause, whichever occurs first.

    Measured: From study start until progressive disease, subsequent therapy or end of study, whichever is earlier (Up to 3 years and 4 months)

  4. Overall Survival (OS)

    OS is measured from the date of enrollment to the date of the participant's death.

    Measured: Up to 3 years and 4 months

  5. Number of Participants with Adverse Event (AE) by Severity

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event.

    Measured: Up to 3 years and 4 months

  6. Number of Participants with Abnormalities in Laboratory Parameters

    Participants with abnormalities in laboratory parameters (hematology, chemistry) will be reported.

    Measured: Up to 3 years and 4 months

  7. Levels of Cilta-cel T-Cell Expansion, and Persistence

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

    Measured: Up to 3 years and 4 months

  8. Number of Participants with Anti-Cilta-Cel Antibodies

    The presence of anti-cilta-cel antibodies will be determined from anti-drug antibody samples collected from each participant.

    Measured: Up to 3 years and 4 months

  9. Percentage of Participants with Presence of Replication-competent Lentivirus (RCL)

    Percentage of participants with presence of RCL will be reported.

    Measured: Up to 3 years and 4 months

Timeline

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

  1. First posted2 Sep 2025
  2. Study start3 Oct 2025
  3. Primary completion12 Apr 2028 (estimated)
  4. Study completion6 Apr 2029 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07149857
Sponsor's protocol ID
68284528MMY2012
Other IDs
68284528MMY2012, 2025-521975-30-00, 2025
Acronym
CARTITUDE-10
Status last verified
Nov 2026
First submitted
25 Aug 2025
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 Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/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 2 study testing Cilta-cel, Cyclophosphamide and Induction therapy in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 20 sites in 3 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 5 inclusion and 4 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: looking for participants now, 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 20 sites in Spain, United States, Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minimal Residual Disease (MRD)-negative Complete Response (CR) After Cilta-cel Infusion (time frame: At least 12 months after Cilta-cel infusion on Day 1). 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 NCT07149857.

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.

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