Multiple Myeloma
Conditions
Interventions
Arm A
Participants will receive bortezomib, lenalidomide, and dexamethasone (VRd) regimen for 6 cycles before randomization.
Following randomization, participants in Arm A will receive 2 more cycles
Sponsors
Nakamura Fumiaki
Eligibility
Sex/Gender
All
Inclusion criteria
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 x10^9/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 (=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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS):Up to 4 years and 5 months:Progression-free survival is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD), as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sustained Minimal Residual Disease (MRD) Negative CR:Up to 12 years and 5 months:Sustained MRD negative complete response (CR) as determined by next generation sequencing (NGS) with sensitivity of 10^-5, and defined by MRD negative CR plus at least 12 months durability of the MRD negative CR status. MRD Negative CR at 9 Months:9 months:MRD negative CR rate at 9 months is defined as the percentage of participants who achieve MRD negative CR status at 9+-3 months after the randomization date. Overall MRD Negative CR:Up to 12 years and 5 months:Overall MRD negative is defined as the percentage of participants who achieve MRD negativity at any time after the date of randomization before initiation of subsequent therapy. Overall Survival (OS):Up to 12 years and 5 months:Overall survival is measured from the date of randomization to the date of the participants death. Complete Response or Better:Up to 12 years and 5 months:CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response according to the IMWG criteria. Time to Subsequent Anti-myeloma Therapy:Up to 12 years and 5 months:Time to subsequent anti-myeloma therapy is defined as the time from randomization to the start of subsequent anti-myeloma therapy. Progression Free Survival on Next-line Therapy (PFS2):Up to 12 years and 5 months:PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as PD as assessed by investigator that starts after the next line of subsequent therapy, or death from any cause, whichever occurs first. Number of Participants with Adverse Events (AEs), Abnormalities in Laboratory Parameters, 12-Lead Electrocardiogram (ECG), Physical Examination, and Vital Signs:Up to 12 years and 5 months:Number of participants with AEs, abnormalities in laboratory parameters (complete blood count [CBC] with differential, coagulation, chimeric antigen receptor T cell [CAR-T] chemistry, full metabol | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Japan, Korea, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom Of Great Britain, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed