Brief Summary
The purpose of this study is to evaluate how well (efficacy) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white bloodthe red bodily fluid that transports oxygen and other nutrients around the body cell in the body, typically through chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells), or an alternative administration of cilta-cel infusionto slowly introduce/give fluid into a vein following a cyclophosphamide and fludarabine lymphodepletion regimen.
Intervention / Treatment
- Drug: Cilta-cel
- Drug: Cyclophosphamide
- Drug: Induction therapy
- Drug: Fludarabine
Inclusion Criteria
- Documented diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of newly diagnosed multiple myeloma (NDMM) according to the most recent international myeloma working group (IMWG) diagnostic criteria and measurable disease at diagnosis (prior to start of any anti-myeloma therapy): Serum monoclonal paraprotein (M-protein) level greater than equal to (>=)1.0 grams per deciliter (g/dL) or urine M-protein level >= 200 milligrams (mg)/24 hours; or light chain multiple myeloma in whom the only measurable disease is by serum free light chain (FLC) levels in the serum: involved serum free light chain >= 10 mg/dL and abnormal serum free light chain ratio
- Not considered a candidate for high-dose chemotherapy with stem cell transplantation due to: (a) Advancedat a late stage, far along age; or (b) Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with stem cell transplantation; or (c) Participant refusal of high-dose chemotherapy with stem cell transplantation as initial treatment
- Participant must have received at least 3 cycles and no more than 5 cycles of induction therapy. Initially, only participants receiving triplet induction therapy with DRd or VRd will be enrolled. Only after sponsor notification, participants receiving quadruplet DVRd induction therapy may be enrolled (screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening can commence as early as during Cycle 3 of induction). Participants must have achieved >= partial response (PR) on the most recent disease assessment to be enrolled
- Eastern cooperative oncologythe study, diagnosis and treatment of cancer group (ECOG) Performance Status score of 0 or 1
- Must be willing and able to adhere to the lifestyle restrictions specified in the protocol