A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy
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1. Progression Free Survival (PFS) (Time Frame - 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 outcome:
1. Sustained Minimal Residual Disease (MRD) Negative CR (Time Frame - 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.
2. MRD Negative CR at 9 Months (Time Frame - 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.
3. Overall MRD Negative CR (Time Frame - 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.
4. Overall Survival (OS) (Time Frame - Up to 12 years and 5 months): Overall survival is measured from the date of randomization to the date of the
participant's death.
5. Complete Response or Better (Time Frame - 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.
6. Time to Subsequent Anti-myeloma Therapy (Time Frame - 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.
7. Progression Free Survival on Next-line Therapy (PFS2) (Time Frame - 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.
8. Number of Participants with Adverse Events (AEs), Abnormalities in Laboratory Parameters, 12-Lead Electrocardiogram (ECG), Physical Examination, and Vital Signs (Time Frame - 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 metabolic panel etc.), 12-lead ECG, physical examination, and vital signs
will be reported.
9. Arm B: Systemic Cytokine Concentrations (Time Frame - Up to Day 112): Serum or plasma proteomic profiling of cytokines (such as interleukin [IL] 6, IL-15, and
IL 10) concentrations will be measured for biomarker assessment.
10. Arm B: Levels of Chimeric Antigen Receptor T cell (CAR-T) Cell Activation Markers (Time Frame - Up to 12 years and 5 months): CAR-T cell activation markers including, but not limited to, CD4+, CD8+, CD25+, central
memory, effector memory cells will be reported. An evaluation of cell populations may be
performed by flow cytometry, cytometry by time of flight (CyTOF), single cell RNA
sequencing (scRNAseq) or similar technologies and be correlated with response.
11. Arm B: Levels of Soluble B-cell Maturation Antigen (BCMA) (Time Frame - Up to 1 year): Levels of soluble BCMA will be reported.
12. Arm B: Levels of Cilta-cel Expansion (proliferation), and Persistence (Time Frame - Up to 12 years and 5 months): Levels of cilta-cel expansion (proliferation), and persistence via monitoring CAR-T
positive cell counts and CAR transgene level will be reported.
13. Arm B: Number of Participants with Anti-cilta-cel Antibodies (Time Frame - Up to 12 years and 5 months): Number of participants with anti-cilta-cel antibodies will be reported.
14. Arm B: Number of Participants with Presence of Replication Competent Lentivirus (Time Frame - Up to 12 years and 5 months): Number of participants with presence of replication competent lentivirus will be
reported.
15. Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score (Time Frame - Baseline up to 12 years and 5 months): The EORTC QLQ-C30 includes 30 items in 5 functional scales (physical, role, emotional,
cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue,
nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss,
constipation, diarrhea, and financial difficulties). The responses are reported using a
verbal rating scale. The item and scale scores are transformed to a 0 to 100 scale. A
higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
16. Change from Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Score (Time Frame - Baseline up to 12 years and 5 months): The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It
includes 17 items with recall period of "7 days" and responses are reported on a 5-point
verbal rating scale. Item responses are scored from 0 to 4. Higher scores indicate
greater severity/impact.
17. Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score (Time Frame - Baseline up to 12 years and 5 months): The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item
questionnaire that assesses 5 domains including mobility, self-care, usual activities,
pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels
of perceived problems, where Level 1: no problem, Level 2: slight problems, Level 3:
moderate problems, Level 4: severe problems and Level 5: extreme problems, plus a visual
analog scale rating "health today" with anchors ranging from 0 (worst imaginable health
state) to 100 (best imaginable health state).
18. Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score (Time Frame - Baseline up to 12 years and 5 months): The PGIS uses 2 items to assess the participant's perception of the severity of their
disease symptoms and impact using a 5-point verbal rating scale. Score ranges from 1
(None) to 5 (Very Severe).
19. Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Items (Time Frame - Up to 161 days): The National Cancer Institute's PRO-CTCAE is an item library of common adverse events
experienced by people with cancer that are appropriate for self-reporting. Each symptom
selected for inclusion can be rated by up to 3 attributes characterizing the
presence/frequency, severity, and/or interference that ranges from 0 to 4 with higher
scores indicating higher frequency or greater severity/impact.
20. Time to Worsening of Symptoms, Functioning and Overall Well-being (Time Frame - Up to 12 year and 5 months): Time to worsening is measured as the interval from the date of randomization to the start
date of worsening in MySIm-Q symptom, impact, or total scores.
Experimental: Arm A: VRd+Rd (Standard Therapy) 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 of VRd. In VRd treatment, participants will receive bortezomib 1.3
milligram per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8 and 11 of each
cycle (Cycles 1 to 8), oral lenalidomide 25 mg on Days 1 to 14 of each cycle (Cycles 1 to
8) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle
(Cycles 1 to 8). Each cycle will consist of 21 days. After 8 cycles of VRd, treatment
will continue with lenalidomide and dexamethasone (Rd) maintenance therapy. In Rd
treatment, participants will receive oral lenalidomide 25 mg on Days 1 to 21 of each
cycle and oral dexamethasone 40 mg on Days 1, 8, 15, and 22 of each cycle. Each cycle
will consist of 28 days. Participants will continue to receive Rd until confirmed
progressive disease or unacceptable toxicity.
Experimental: Arm B: VRd+Ciltacabtagene Autoleucel (Cilta-cel) Participants will receive VRd regimen for 6 cycles before randomization. Following
randomization, participants in Arm B will undergo apheresis and receive two more cycles
of VRd as bridging therapy. In VRd treatment, participants will receive bortezomib 1.3
mg/m^2 SC on Days 1, 4, 8 and 11 of each cycle for Cycles 1 to 8; oral lenalidomide 25 mg
on days 1 to 14 of each cycle for Cycles 1 to 8 and oral dexamethasone 20 mg on days 1,
2, 4, 5, 8, 9, 11 and 12 of each cycle for Cycles 1 to 8. Each cycle will consist of 21
days. After 8 cycles of VRd, participants will receive a conditioning regimen
(cyclophosphamide 300 mg/m^2 intravenous [IV] and fludarabine 30 mg/m^2 IV daily for 3
days) and Cilta-cel infusion 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T
cells/kilogram (kg).
Dexamethasone: Dexamethasone will be administered orally.
Lenalidomide: Lenalidomide will be administered orally.
Cilta-cel (JNJ-68284528): Cilta-cel infusion will be administered.
Cyclophosphamide: Cyclophosphamide will be administered intravenously.
Fludarabine: Fludarabine will be administered intravenously.
Quelle: ClinicalTrials.gov
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"A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy"
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