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 · tracked via the Priya Life Science Spain tracker

Sponsor

Janssen Research & Development, LLC

Phase

Phase 2

Started

2024-08-20

Last updated

2026-09-25

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Cilta-cel →Talquetamab →Daratumumab →Teclistamab →Bortezomib →Lenalidomide →Dexamethasone →Cyclophosphamide →Fludarabine →

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.

Study 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. 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Primary outcome measure(s)

Rate of Response with Curative Potential — Up to 5 years
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.
Progression Free Survival (PFS) Rate at 3-Year — 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.
PFS Rate at 5-Year — 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.

Trial sites (16)

Facility	City	Region
City of Hope	Duarte	California
University of California San Francisco	San Francisco	California
University of Iowa Hospital and Clinics	Iowa City	Iowa
Memorial Sloan Kettering Cancer Center	New York	New York
Levine Cancer Institute	Charlotte	North Carolina
Peter MacCallum Cancer Centre	Melbourne	Australia
The Alfred Hospital	Melbourne	Australia
IDOR - Regional Bahia	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

On this site

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Other trials for the same condition

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06577025 on ClinicalTrials.gov ↗ ← All trials in Spain