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Multiple MyelomaPhase 2MonumenTAL-8NCT06550895

A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

A Phase 2 study testing Cilta-cel and Talquetamab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 9 sites in 2 countries.

Active, not recruiting

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

Official record
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Trial summary

The purpose of this study is to define the safety of Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab in participants with high-risk multiple myeloma (MM). 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?
Cilta-cel and Talquetamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
9 sitesin 2 countries
Study dates
16 Sep 2024to 26 Aug 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented diagnosis of MM according to the IMWG diagnostic criteria and is defined as a measurable disease at screening
  • Cohort 1: Received at least 3 prior lines of antimyeloma therapy and have undergone greater than or equal to (>=) 1 complete cycle of the therapy
  • Cohort 1: Documented evidence of progression of disease (PD) or failure to achieve a response to the last line of therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Participant of childbearing potential (POCBP) must have a negative pregnancy test using a highly sensitive β-human chorionic gonadotropin (hCG) serum pregnancy test at screening

Who cannot join

  • Cohort 1: Prior treatment with chimeric antigen receptor T cell (CAR-T) therapy directed at any target or any prior B cell maturation antigen (BCMA)-directed therapy/prior G protein-coupled receptor family C Group 5 member D (GPRC5D)-directed therapy
  • Cohort 1: Received either of the following: An allogenic stem cell transplant within 6 months before apheresis/first dose of study drug and no immunosuppressive medications administered before the start of study treatment. And secondly, received an autologous stem cell transplant less than (<)12 weeks before apheresis/first dose of study treatment
  • Receive live, attenuated vaccine within 4 weeks of enrollment
  • Toxicity from previous anticancer therapy not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
  • Stroke, transient ischemic attack, or seizure within 6 months of signing informed consent form

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

United States5 sites

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

Australia4 sites

  • Royal Prince Alfred Hospital

    Camperdown, 2050

  • Austin Hospital

    Heidelberg, 3084

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

  • The Alfred Hospital

    Melbourne, 3004

Other trials in Australia

About this study

Official title: A Phase 2, Open-Label, Multicenter Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma

The purpose of this study is to define the safety of Ciltacabtagene Autoleucel (Cilta-cel) and Talquetamab in participants with high-risk multiple myeloma (MM).

Being tested
Cilta-cel, Talquetamab
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 Ciltacabtagene autoleucel, JNJ-68284528

    Cilta-cel infusion will be administered intravenously.

  • TalquetamabDrug

    Also called JNJ-64407564

    Talquetamab will be administered subcutaneously.

Study groups in NCT06550895
Study groupRoleWhat they receive
Cohort 1:Cilta-cel + Talquetamab Consolidation Post Chimeric Antigen Receptor T cell (CAR-T) TherapyExperimentalParticipants with relapsed and/or refractory multiple myeloma (RRMM) will be administered Cilta-cel followed by multiple cycles of talquetamab consolidation treatment and will be followed up until death, lost to follow-up, consent withdrawal, or study end, whichever occurs first.
Receives: Drug: Cilta-cel; Drug: Talquetamab

What is being measured

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

  1. Number of Participants With Adverse Events (AE) by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product. The severity of AEs has 5 grades based on NCI-CTCAE version 5.0 criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death.

    Measured: Up to 3 years and 5 months

Secondary outcomes (7)

  1. Percentage of Participants With Overall Response (OR)

    The percentage of participants who have a partial response (PR) or better response according to the International Myeloma Working Group (IMWG) response criteria will be reported.

    Measured: Up to 3 years and 5 months

  2. Percentage of Participants with Very Good Partial Response (VGPR) or Better

    The percentage of participants who achieve a VGPR or better response according to the IMWG response criteria will be reported.

    Measured: Up to 3 years and 5 months

  3. Percentage of Participants with Complete Response (CR) or Stringent Complete Response (sCR)

    The percentage of participants with best overall response of CR or sCR will be reported according to IMWG criteria.

    Measured: Up to 3 years and 5 months

  4. Duration of Response (DOR)

    DOR is defined as the time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease (PD) (defined in the IMWG response criteria) or death due to any cause, whichever occur first.

    Measured: Up to 3 years and 5 months

  5. Time to Response (TTR)

    TTR is defined as the time between date of the first study treatment and the first efficacy evaluation that the participant met all criteria for PR or better.

    Measured: Upto 3 years and 5 months

  6. Progression Free Survival (PFS)

    PFS is defined as the time from the date of the first study treatment to the date of first documented disease progression (defined in the IMWG response criteria), or death due to any cause, whichever occurs first.

    Measured: Up to 3 years and 5 months

  7. Overall Survival

    Overall Survival is measured from the date of the first study treatment to the date of the participant's death.

    Measured: Up to 3 years 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 posted13 Aug 2024
  2. Study start16 Sep 2024
  3. Primary completion26 Aug 2027 (estimated)
  4. Study completion26 Aug 2027 (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
Sequential
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06550895
Sponsor's protocol ID
64407564MMY2008
Other IDs
2023-507989-76-00, 2023
Acronym
MonumenTAL-8
Status last verified
Nov 2026
First submitted
9 Aug 2024
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 www.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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cilta-cel and Talquetamab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 9 sites in 2 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 5 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 9 sites in 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?

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?

Number of Participants With Adverse Events (AE) by Severity According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 (time frame: Up to 3 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 NCT06550895.

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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