Clinical study comparing Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by Ciltacabtagene autoleucel (Cilta-Cel), a CAR-T cell immunotherapy, with Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by Lenalidomide and Dexamethasone (Rd) in patients with newly diagnosed Multiple Myeloma (MM), for whom no stem cell transplantation is planned as first-line therapy.

Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States (ICTRP)

ID di studio ICTRP
NCT04923893 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants with Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy (BASEC)

Titolo accademico
A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy (ICTRP)

Titolo pubblico
A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy (ICTRP)

Malattie studiate
Multiple Myeloma (ICTRP)

Intervento studiato
Drug: BortezomibDrug: DexamethasoneDrug: LenalidomideDrug: Cilta-celDrug: CyclophosphamideDrug: Fludarabine (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
Inclusion Criteria:

- Documented diagnosis of multiple myeloma (MM) according to International Myeloma
Working Group (IMWG) diagnostic criteria

- Measurable disease at screening as defined by any of the following: Serum monoclonal
paraprotein (M-protein) level greater than or equal to (>=)1.0 gram per deciliter
(g/dL) or urine M-protein level >=200 milligram (mg)/24 hours or Light chain MM in
whom only measurable disease is by serum free light chain (FLC) levels: Serum
immunoglobin (Ig) free light chain >=10 milligrams per deciliter (mg/dL) and
abnormal serum Ig kappa/lambda FLC ratio

- Eastern Cooperative Oncology Group Performance Status grade of 0 or 1

- Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant
(ASCT) due to: Ineligible due to advanced age or Ineligible due to presence of
comorbid condition(s) likely to have a negative impact on tolerability of high-dose
chemotherapy with ASCT or Deferral of high-dose chemotherapy with ASCT as initial
treatment

- A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive
serum or urine pregnancy tests (beta-human chorionic gonadotropin) prior to starting
Bortezomib, Lenalidomide and Dexamethasone (VRd) and must agree to further testing
during the study.

- Clinical laboratory values meeting the following criteria during the screening
phase: hemoglobin greater than or equal to (>=) 8.0 g/dL (>=5 millimoles per liter
[mmol/L]), recombinant human erythropoietin use is permitted platelets >=75
*10^9/L absolute lymphocyte count >=0.3 *10^9/L absolute neutrophil count (ANC)
>=1.0 10^9/L (prior growth factor support is permitted but must be without support
in the 7 days prior to the laboratory test) aspartate aminotransferase (AST) and
alanine aminotransferase (ALT) less than or equal to (<=) 3.0 * upper limit of
normal (ULN) estimated glomerular filtration rate >=40 milliliter per minute/1.73
meter square (mL/min/1.73 m^2) based upon modified diet in renal disease formula
(MDRD-4) calculation or a 24-hour urine collection total bilirubin <=2.0 * ULN
except in participants with congenital hyperbilirubinemia, such as Gilbert syndrome
(in which case direct bilirubin <=2.0 * ULN is required)

Exclusion Criteria:

- Frailty index of >=2 according to Myeloma Geriatric Assessment score

- Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the
National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Version 5

- Known active, or prior history of central nervous system (CNS) involvement or
clinical signs of meningeal involvement of MM

- Stroke or seizure within 6 months of signing Informed Consent Form (ICF)

- Seropositive for human immunodeficiency virus (HIV)

- Vaccinated with live, attenuated vaccine within 4 weeks prior to first dose of VRd

- Participant must not require continuous supplemental oxygen

- Hepatitis B infection

- Hepatitis C infection

- Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any
target

- Any therapy that is targeted to B-cell maturation antigen (BCMA) (ICTRP)

non disponibile

Endpoint primari e secondari
Progression Free Survival (PFS) (ICTRP)

Sustained Minimal Residual Disease (MRD) Negative CR;MRD Negative CR at 9 Months;Overall MRD Negative CR;Overall Survival (OS);Complete Response or Better;Time to Subsequent Anti-myeloma Therapy;Progression Free Survival on Next-line Therapy (PFS2);Number of Participants with Adverse Events (AEs), Abnormalities in Laboratory Parameters, 12-Lead Electrocardiogram (ECG), Physical Examination, and Vital Signs;Arm B: Systemic Cytokine Concentrations;Arm B: Levels of Chimeric Antigen Receptor T cell (CAR-T) Cell Activation Markers;Arm B: Levels of Soluble B-cell Maturation Antigen (BCMA);Arm B: Levels of Cilta-cel Expansion (proliferation), and Persistence;Arm B: Number of Participants with Anti-cilta-cel Antibodies;Arm B: Number of Participants with Presence of Replication Competent Lentivirus;Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score;Change from Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Score;Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score;Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score;Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Items;Time to Worsening of Symptoms, Functioning and Overall Well-being (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC (ICTRP)

ID secondari
68284528MMY3004, 2021-001242-35, 2023-505850-16-00, CR109015 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT04923893 (ICTRP)