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

Cancer Categories

Hematologic (Blood Cancers)

Karmanos Trial ID

2022-012

NCT ID

NCT04923893

Age Group

Adult

Scope

National

Phase

Phase III

Principal Investigator

Abhinav
Deol, M.D.
Oncology - Hematology, Oncology - Medical View Profile

Objective:

Primary Objectives:

To compare the efficacy of VRd induction followed by a single administration of cilta-cel versus VRd induction followed by Rd maintenance in terms of PFS

Secondary Objectives:

To characterize MRD negativity
To further compare the efficacy of VRd induction followed by a single administration of cilta-cel versus VRd induction followed by Rd maintenance
To characterize the safety of cilta-cel VRd induction followed by a single administration of cilta-cel versus VRd induction followed by Rd maintenance
To characterize the pharmacokineticsand pharmacodynamics of cilta-cel
To assess the immunogenicity of cilta-cel
To determine whether replication competent lentivirus is present in participants that receive cilta-cel
To evaluate the patient-reported outcomes (PRO) associated with VRd induction followed by single administration of cilta-cel versus VRd induction followed by Rd maintenance

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Eligibility

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)

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices