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

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying new treatment combinations for patients with a type of cancer called multiple myeloma, specifically those who have just been diagnosed and are considered standard-risk. The trial aims to see how effective these treatments are over a five-year period, focusing on whether patients can remain free of detectable cancer after treatment. Participants will receive a series of treatments and will be monitored to see how long they can live with the disease without it getting worse.

To be eligible for this trial, participants must have a confirmed diagnosis of multiple myeloma and meet certain health criteria, including having some measurable signs of the disease. They should also be in relatively good health, meaning they can perform daily activities without significant limitations. Throughout the trial, participants can expect regular check-ups and tests to monitor their response to the treatment and overall health. It’s important to note that some patients may not qualify if they have certain other health issues or specific high-risk features related to their cancer.

Gender

ALL

Eligibility criteria

• 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)