Evaluating treatment sequences for 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

This study is testing different treatment plans for people with newly diagnosed multiple myeloma to see which one helps them respond better and live longer without the disease coming back.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Janssen Research & Development, LLC (Industry-sponsored)
• Locations: 15 sites (Duarte, California and 14 other locations)
• Trial ID: NCT06577025 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of different treatment sequences involving Cilta-cel, Talquetamab, and Daratumumab in patients with standard-risk newly diagnosed multiple myeloma. Participants will receive induction therapy with Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone, followed by various combinations of the aforementioned treatments. The primary goal is to evaluate the rate of response and potential cure at five years, focusing on minimal residual disease negativity and overall survival without disease progression.

Who should consider this trial

Good fit: Ideal candidates include individuals with a new diagnosis of standard-risk multiple myeloma who have not received prior myeloma-directed therapy.

Not a fit: Patients with high-risk multiple myeloma or those who have previously undergone myeloma-directed therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols that significantly enhance long-term outcomes for patients with multiple myeloma.

How similar studies have performed: Other studies have shown promising results with similar treatment combinations in multiple myeloma, indicating potential for success in this approach.

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)

Where this trial is running

Duarte, California and 14 other locations

• City of Hope — Duarte, California, United States (Recruiting)
• University of California San Francisco — San Francisco, California, United States (Recruiting)
• University of Iowa Hospital and Clinics — Iowa City, Iowa, United States (Recruiting)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
• Levine Cancer Institute — Charlotte, North Carolina, United States (Recruiting)
• Peter MacCallum Cancer Centre — Melbourne, Australia (Recruiting)
• The Alfred Hospital — Melbourne, Australia (Recruiting)
• Instituto D Or de Pesquisa e Ensino — Salvador, Brazil (Recruiting)
• Fundacao Antonio Prudente A C Camargo Cancer Center — Sao Paulo, Brazil (Recruiting)
• Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein — Sao Paulo, Brazil (Recruiting)
• Universitaetsklinikum Tuebingen — Tuebingen, Germany (Recruiting)
• Universitatsklinikum Wurzburg — Wuerzburg, Germany (Recruiting)
• Hosp. Univ. 12 de Octubre — Madrid, Spain (Recruiting)
• Hosp Clinico Univ de Salamanca — Salamanca, Spain (Recruiting)
• Hosp. Univ. Marques de Valdecilla — Santander, Spain (Recruiting)

Study contacts

• Study coordinator: Study Contact

Conditions Multiple Myeloma