Phase 3, Randomized Study comparing Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by an investigational CAR-T versus VRd followed by Lenalidomide and Dexamethasone (RD)Therapy in subjects with newly diagnosed Multiple Myeloma for whom Stem Cell Transplant is not planned as initial therapy

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Overview

This trial is comparing the safety and efficacy of VRd followed by an investigational CAR-T cell therapy versus VRd and Rd in participants with newly diagnosed multiple myeloma.

SparkCures ID 1182
Trial Phase Phase 3
Enrollment 743 Patients
Treatments
Tags
Trial Sponsors
  • Janssen Research & Development LLC
NCT Identifier

NCT04923893

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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 (beta-human chorionic gonadotropin) tests prior to starting Bortezomib, Lenalidomide and Dexamethasone (VRd). The first test must be within 10 to 14 days prior to the start of VRd
  • 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)

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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