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NCT06577025Active, not recruitingPhase 2

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, 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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
43 (actual)
First submitted
27 Aug 2024
Start date
20 Aug 2024
Primary completion date
2 Sept 2030
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT06577025
EU CT number
2023-505792-71-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 43
  • From 20 Aug 2024 to the primary completion date, 2 Sept 2030
  • 16 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Known active or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM

Other illness

  • 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
  • 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)

Who the study is looking for

  • 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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Alfred Hospital
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Peter MacCallum Cancer Centre
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
IDOR - Regional Bahia
Coordinator of this site? Confirm its status
SalvadorBrazilUnknown status
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Fundacao Antonio Prudente A C Camargo Cancer Center
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Universitaetsklinikum Heidelberg AöR
Coordinator of this site? Confirm its status
HeidelbergGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
Coordinator of this site? Confirm its status
TuebingenGermanyActive, not recruiting
Universitaetsklinikum Wuerzburg AöR
Coordinator of this site? Confirm its status
WuerzburgGermanyActive, not recruiting
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainActive, not recruiting
Hospital Universitario De Salamanca
Coordinator of this site? Confirm its status
SalamancaSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
Coordinator of this site? Confirm its status
SantanderSpainActive, not recruiting
Levine Cancer Institute
Coordinator of this site? Confirm its status
CharlotteUnited StatesUnknown status
City of Hope
Coordinator of this site? Confirm its status
DuarteUnited StatesUnknown status
University of Iowa Hospital and Clinics
Coordinator of this site? Confirm its status
Iowa CityUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
University of California San Francisco
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.

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 (NCT06577025) – Frontlight Research