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
NCT ID: NCT06577025
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
43 participants
INTERVENTIONAL
2024-08-20
2030-09-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A: DVRd Induction + Tal-D Consolidation + Cilta-cel
Participants 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.
Cilta-cel
Cilta-cel infusion will be administered intravenously.
Talquetamab
Talquetamab will be administered subcutaneously.
Daratumumab
Daratumumab will be administered subcutaneously as a part of DVRd induction and Tal-D or Tec-D consolidation.
Bortezomib
Bortezomib will be administered subcutaneously as a part of induction.
Lenalidomide
Lenalidomide will be administered orally as a part of induction.
Dexamethasone
Dexamethasone will be administered orally as a part of induction.
Cyclophosphamide
Cyclophosphamide will be administered intravenously as a part of conditioning regimen.
Fludarabine
Fludarabine will be administered intravenously as a part of conditioning regimen.
Cohort B: DVRd Induction + Cilta-cel + Tal-D and Tec-D Consolidation
Participants 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.
Cilta-cel
Cilta-cel infusion will be administered intravenously.
Talquetamab
Talquetamab will be administered subcutaneously.
Daratumumab
Daratumumab will be administered subcutaneously as a part of DVRd induction and Tal-D or Tec-D consolidation.
Teclistamab
Teclistamab will be administered subcutaneously.
Bortezomib
Bortezomib will be administered subcutaneously as a part of induction.
Lenalidomide
Lenalidomide will be administered orally as a part of induction.
Dexamethasone
Dexamethasone will be administered orally as a part of induction.
Cyclophosphamide
Cyclophosphamide will be administered intravenously as a part of conditioning regimen.
Fludarabine
Fludarabine will be administered intravenously as a part of conditioning regimen.
Interventions
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Cilta-cel
Cilta-cel infusion will be administered intravenously.
Talquetamab
Talquetamab will be administered subcutaneously.
Daratumumab
Daratumumab will be administered subcutaneously as a part of DVRd induction and Tal-D or Tec-D consolidation.
Teclistamab
Teclistamab will be administered subcutaneously.
Bortezomib
Bortezomib will be administered subcutaneously as a part of induction.
Lenalidomide
Lenalidomide will be administered orally as a part of induction.
Dexamethasone
Dexamethasone will be administered orally as a part of induction.
Cyclophosphamide
Cyclophosphamide will be administered intravenously as a part of conditioning regimen.
Fludarabine
Fludarabine will be administered intravenously as a part of conditioning regimen.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
70 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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City of Hope
Duarte, California, United States
University of California San Francisco
San Francisco, California, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Peter MacCallum Cancer Centre
Melbourne, , Australia
The Alfred Hospital
Melbourne, , Australia
Instituto D Or de Pesquisa e Ensino
Salvador, , Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, , Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, , Brazil
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Universitatsklinikum Wurzburg
Würzburg, , Germany
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp Clinico Univ de Salamanca
Salamanca, , Spain
Hosp. Univ. Marques de Valdecilla
Santander, , Spain
Countries
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Other Identifiers
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54767414MMY2093
Identifier Type: OTHER
Identifier Source: secondary_id
2023-505792-71-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
54767414MMY2093
Identifier Type: -
Identifier Source: org_study_id