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
Running, not enrolling · Phase 2
Conditions studied: Multiple Myeloma
In brief
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.
Key facts
- Study ID
- NCT06577025
- Run by
- Janssen Research & Development, LLC
- People needed
- 43
- Starts
- 2024-08-20
- Expected to finish
- 2030-09-30
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- 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
Full record on ClinicalTrials.gov
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