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

Phase 3

Conditions: Multiple Myeloma / symptomatic plasma cell disorder
10018865

Registration Number: NL-OMON56056

Lead Sponsor: Janssen-Cilag

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 18

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. For
participants that have received 1 cycle of VRd therapy prior to enrollment (as
allowed by Exclusion Criterion 17) measurable disease must be assessed by local
laboratory on the most recent evaluation prior to the start of the VRd therapy.
- Eastern Cooperative Oncology Group (ECOG) 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 (beta-human chorionic gonadotropin) tests
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 (>)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 defined as (anti-hepatitis C virus [HCV] antibody
positive or detectable HCV- ribonucleic acid [RNA]) or known to have a history
of hepatitis C
- 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)