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Multiple MyelomaPhase 2aMMbitionNCT06577025

A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma

A Phase 2 study testing Cilta-cel, Talquetamab and Daratumumab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 16 sites in 5 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 evaluate the rate of response (how effectively treatment is working) with signs of potential cure at 5 years after the start of induction treatment. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Cilta-cel, Talquetamab and Daratumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
16 sitesin 5 countries
Study dates
20 Aug 2024to 30 Sep 2030
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with documented new diagnosis of multiple myeloma (MM) according to international myeloma working group (IMWG) diagnostic criteria and with no prior myeloma-directed therapy
  • Participants must have standard-risk MM (stage I and II) based on revised International Staging System (R-ISS)
  • Participants must be considered fit (score equals to [=] 0) or intermediate-fit (score=1) according to IMWG Frailty Index assessment (based on the Charlson Comorbidity Index, the Katz Activity of Daily Living and the Lawson Instrumental Activities of Daily Living)
  • Measurable disease defined as: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) (>=10 gram per liter [g/L] for institutions using alternative units) or urine M-protein level >= 200 milligrams per 24 hours (mg/24 hours); Light chain MM without measurable disease in the serum or the urine: Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) (>=100 mg/L for institutions using alternative units) and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

Who cannot join

  • Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM). Any history of malignancy, other than MM, which is considered at high risk of recurrence requiring systemic therapy
  • Peripheral neuropathy or neuropathic pain of Grade >= 2, as defined by National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
  • Known active or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM
  • Stroke or seizure within 6 months of signing the informed consent form (ICF)
  • Plasma cell leukemia at the time of diagnosis or any time thereafter through apheresis (>= 5 percent [%] circulating plasma cells in peripheral blood smears), Waldenstrom macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes(POEMS) syndrome, or primary amyloid light chain amyloidosis with associated organ dysfunction
  • Presence of high-risk disease features: (a) Cytogenetic high risk lesions by MM fluorescence in situ hybridization (FISH) including deletion 17p (del[17p])/, t(4;14), t(14;16), amplification 1q (amp[1q21]) (>= 4 copies); (b) Presence of 1 or more extramedullary plasmacytomas
  • Seropositive for human immunodeficiency virus (HIV)

Trial locations and contacts

16 sites in 5 countries.

16 sites in 5 countries

United States5 sites

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • City of Hope

    Duarte, California, 91010

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of California San Francisco

    San Francisco, California, 94143

Other trials in United States

Brazil3 sites

  • IDOR - Regional Bahia

    Salvador, 41253-190

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652 900

Other trials in Brazil

Germany3 sites

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

  • Universitatsklinikum Wurzburg

    Würzburg, 97080

Other trials in Germany

Spain3 sites

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

Other trials in Spain

Australia2 sites

  • 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 Study to Evaluate the Efficacy and Safety of Different Sequences of Ciltacabtagene Autoleucel (Cilta-cel), Talquetamab SC in Combination With Daratumumab SC (Tal-D) and Teclistamab SC in Combination With Daratumumab SC (Tec-D) Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Participants With Standard-risk Newly Diagnosed Multiple Myeloma

The purpose of this study is to evaluate the rate of response (how effectively treatment is working) with signs of potential cure at 5 years after the start of induction treatment. This is defined as a composite of sustained (at least 2 years) minimal residual disease (MRD) negativity with complete response/stringent complete response (CR/sCR) and a positron emission tomography/computed tomography (PET/CT) scan that does not show any signs of cancer at 5 years. MRD negativity and CR/sCR is defined as no detectable signs of remaining cancer cells after the treatment. This study will also characterize how well the treatments administered work in the study through progression-free survival (PFS). PFS is defined as the length of time during and after the treatment of a disease, that a participant lives with the disease, but it does not get worse.

Being tested
Cilta-cel, Talquetamab, Daratumumab, Teclistamab, Bortezomib
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, Ciltacabtagene autoleucel

    Cilta-cel infusion will be administered intravenously.

  • TalquetamabDrug

    Also called JNJ-64407564

    Talquetamab will be administered subcutaneously.

  • DaratumumabDrug

    Also called JNJ-54767414

    Daratumumab will be administered subcutaneously as a part of DVRd induction and Tal-D or Tec-D consolidation.

  • TeclistamabDrug

    Also called JNJ-64007957

    Teclistamab will be administered subcutaneously.

  • BortezomibDrug

    Bortezomib will be administered subcutaneously as a part of induction.

  • LenalidomideDrug

    Lenalidomide will be administered orally as a part of induction.

  • DexamethasoneDrug

    Dexamethasone will be administered orally as a part of induction.

  • CyclophosphamideDrug

    Cyclophosphamide will be administered intravenously as a part of conditioning regimen.

  • FludarabineDrug

    Fludarabine will be administered intravenously as a part of conditioning regimen.

Study groups in NCT06577025
Study groupRoleWhat they receive
Cohort A: DVRd Induction + Tal-D Consolidation + Cilta-celExperimentalParticipants will undergo apheresis followed by 4 cycles of DVRd induction (each cycle is of 28 days) and cilta-cel will be generated from the participants' T-cells selected from the apheresis product. Upon completion of cilta-cel production, product release, and completion of induction, participants will begin consolidation with 4 cycles of Tal-D (each cycle is of 28 days), followed by a conditioning regimen (cyclophosphamide and fludarabine daily for 3 days); cilta-cel will be administered 5 to 7 days after the start of the conditioning regimen.
Receives: Drug: Cilta-cel; Drug: Talquetamab; Drug: Daratumumab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Cyclophosphamide; Drug: Fludarabine
Cohort B: DVRd Induction + Cilta-cel + Tal-D and Tec-D ConsolidationExperimentalParticipants will undergo apheresis followed by 4 cycles of DVRd induction and Cilta-cel will be generated from the participants' T-cells selected from the apheresis product. Upon completion of cilta-cel production, product release and completion of induction, participants will begin consolidation with a conditioning regimen (cyclophosphamide and fludarabine daily for 3 days) with infusion of cilta-cel 5 to 7 days after the start of the conditioning regimen. Following cilta-cel infusion, alternating cycles of Tal-D (Cycle 1, 3, 5, and 7) and Tec-D (Cycle 2, 4, 6, and 8) will be started, no earlier than Day 84 and no later than Day 168 post cilta-cel infusion. Each cycle of Tal-D or Tec-D is 84 days which includes an extended treatment-free interval.
Receives: Drug: Cilta-cel; Drug: Talquetamab; Drug: Daratumumab; Drug: Teclistamab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

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

  1. Rate of Response with Curative Potential

    Rate of Response with curative potential is defined as the percentage of participants with a composite of durable (at least 2 years) minimal residual disease (MRD) (10^-5) negativity with complete response/stringent complete response (CR/sCR) by serology and negative positron emission tomography/computed tomography (PET/CT) imaging at 5-years after start of induction therapy. This includes: negative imaging at 5-year landmark time; MRD-negative status (at 10^-5) in 2 bone marrow examinations that are a minimum of 2 years apart; response of CR or better per the International Myeloma Working Group (IMWG) criteria; no examination showing MRD-positive status or relapse from CR in between assessments.

    Measured: Up to 5 years

  2. Progression Free Survival (PFS) Rate at 3-Year

    PFS is defined as the time from the date of randomization to either progressive disease (PD), according to the IMWG response criteria, or death, whichever occurs first.

    Measured: At 3-year

  3. PFS Rate at 5-Year

    PFS is defined as the time from the date of randomization to either PD, according to the IMWG response criteria, or death, whichever occurs first.

    Measured: At 5-year

Secondary outcomes (12)

  1. Overall response rate (ORR; Partial response [PR] or better)

    ORR (PR or better) is defined as the percentage of participants with best overall response of PR or better according to IMWG response criteria.

    Measured: Up to 5 years

  2. CR or Better Rate

    Rate of CR or better is defined as the percentage of participants with best overall response of CR or better according to IMWG response criteria.

    Measured: Up to 5 years

  3. Very Good Partial Response (VGPR) or Better Rate

    Rate of VGPR or better is defined as the percentage of participants with best overall response of VGPR or better rate according to IMWG response criteria.

    Measured: Up to 5 years

  4. Duration of Response (DOR)

    DOR is calculated among responders (with a PR or better response) from the date of initial documented response (PR or better) to the date of first documented evidence of PD as defined according to IMWG criteria or death due to any cause, whichever occurs first.

    Measured: Up to 5 years

  5. Time to First Response (TTR)

    Time to response (that is, time to first response) is defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for PR or better based on the computerized algorithm per IMWG criteria for those who had PR or better as their best response.

    Measured: Up to 5 years

  6. Duration of CR or Better Response

    Duration of CR or better response is calculated among responders (with a CR or better response) from the date of initial documented response CR or better to the date of first documented evidence of PD as defined according to IMWG criteria or death due to any cause, whichever occurs first.

    Measured: Up to 5 years

  7. Time to First CR or Better Response

    Time to first CR or better response is defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for CR or better based on the computerized algorithm per IMWG criteria.

    Measured: Up to 5 years

  8. PFS on next line therapy (PFS2)

    PFS2 is defined as time from randomization to progression on the next line of therapy or death, whichever comes first.

    Measured: Up to 5 years

  9. Overall Survival (OS)

    OS is measured from the date of randomization to the date of death due to any cause.

    Measured: Up to 5 years

  10. MRD-negative CR Rate

    MRD-negative CR is defined as the percentage of participants who achieved both CR or better and MRD negativity at a threshold of 10^-5 and 10^-6. MRD-negative CR rate will be evaluated at the first occurrence from induction treatment initiation for participants per IMWG criteria.

    Measured: Up to 5 years

  11. Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity

    An Adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. Severity of TEAEs 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) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse events.

    Measured: Up to 5 years

  12. Change from baseline in Health-related quality of life (HRQoL) (symptoms and functioning) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 item instrument (EORTC-QLQ-C30)

    Change from baseline in participants' HRQoL (symptoms and functioning) as assessed by EORTC-QLQ-C30 will be reported. The EORTC-QLQ-C30 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, social), 1 global health status scale, 3 symptom scales (pain, fatigue, nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). The recall period is 1 week ("past week") and 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 5 years

Timeline

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

  1. First posted29 Aug 2024
  2. Study start20 Aug 2024
  3. Primary completion2 Sep 2030 (estimated)
  4. Study completion30 Sep 2030 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06577025
Sponsor's protocol ID
54767414MMY2093
Other IDs
54767414MMY2093, 2023-505792-71-00, 2023
Acronym
aMMbition
Status last verified
Nov 2026
First submitted
27 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 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, Talquetamab and Daratumumab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 16 sites in 5 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 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 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 16 sites in United States, Brazil, Germany, Spain, 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?

Rate of Response with Curative Potential (time frame: Up to 5 years). The study lists 3 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 NCT06577025.

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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