Newly Diagnosed Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, CAR-T, ddBCMA, BCMA
Brief summary
The goal of this clinical study iMMagine-6 is to compare and assess the safety and effectiveness of anitocabtagene autoleucel versus autologous stem cell transplant in participants with newly diagnosed multiple myeloma (NDMM). The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel administered after quadruplet-based induction versus standard of care therapy (SOCT; quadruplet-based induction followed by autologous stem cell transplant (auto-SCT) in participants with NDMM who are eligible for auto-SCT.
Detailed description
After completing quadruplet-based induction therapy followed by anitocabtagene autoleucel or autologous stem cell transplant, participants in both treatment arms will receive maintenance therapy for up to 36 cycles. After completing the maintenance treatment period, participants will continue in a follow-up period for disease assessment and outcomes.
Interventions
A single infusion of CAR+ transduced autologous T cells
DRUGIsatuximab
Administered subcutaneously (SC)
DRUGBortezomib
Administered SC
DRUGLenalidomide
Administered orally (PO)
DRUGDexamethasone
Administered orally (PO)
DRUGFludarabine
Administered IV
DRUGCyclophosphamide
Administered IV
DRUGMelphalan
Administered intravenously (IV)
Sponsors
Kite, A Gilead Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Documented NDMM according to IMWG diagnostic criteria * Considered to be transplant-eligible by the investigator * Measurable disease at screening per IMWG, defined as any of the following: 1. Serum M-protein level ≥ 1.0 g/dL; or 2. Urine M-protein level ≥ 200 mg/24 hours; or 3. Serum free light chain (FLC) ≥ 10 mg/dL (100 mg/L) and abnormal serum FLC ratio * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ function including hematological, renal, hepatic and cardiac with further details in protocol defined inclusion/
Exclusion criteria
Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimal Residual Disease (MRD)-Negative Complete Response (CR) or Stringent CR (sCR) Rate at 12 Months | Up to 12 months | Minimal residual disease (MRD)-negative CR/sCR is defined as the proportion of participants achieving CR/sCR and MRD-negative status (10\^5 cutoff) at 12 months. CR/sCR per International Myeloma Working Group (IMWG) criteria is determined by the Independent Review Committee (IRC). |
| Progression-Free Survival (PFS) | Up to 15 years | PFS is defined as the time from randomization to the first documented disease progression per International Myeloma Working Group (IMWG) criteria as determined by the Independent Review Committee (IRC), or death due to any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to 15 years | OS is defined as the time from randomization to death due to any cause. |
| Overall Response Rate (ORR) | Up to 15 years | ORR is defined as the proportion of participants who achieve a best overall response of at least PR or better (sCR, CR, very good partial response (VGPR), or PR) per the 2016 IMWG criteria as determined by the IRC. |
| Rate of Very Good Partial Response or Better | Up to 15 years | Rate of VGPR or better is defined as the proportion of participants who achieve a best overall response of sCR, CR, or VGPR per the 2016 IMWG criteria as determined by the IRC. |
| Rate of CR or Better | Up to 15 years | Rate of CR or better is defined as the proportion of participants who achieve a best overall response of CR or sCR per the 2016 IMWG criteria as determined by the IRC. |
| Time to Response (TTR) | Up to 15 years | TTR is defined as the time from date of randomization to the earliest date when a participant achieves a best overall response of sCR, CR, VGPR, or PR per 2016 IMWG criteria as determined by the IRC. |
| Duration of response (DOR) | Up to 15 years | DOR is derived only among participants who experience an overall response (sCR, CR, VGPR, or PR) per the 2016 IMWG criteria and is defined as the time from first overall response to disease progression per the 2016 IMWG criteria as determined by the IRC, or death from any cause, whichever occurs first. |
| Time to Progression (TTP) | Up to 15 years | TTP is defined as the time from randomization to the first documented disease progression per the 2016 IMWG criteria as determined by the IRC, or death due to disease progression, whichever occurs first. |
| Percentage of Participants Experiencing Serious Adverse Events (SAEs) | Enrollment up to 15 years | — |
| Percentage of Participants Experiencing Adverse Events (AEs) | Enrollment up to 15 years | — |
| Percentage of Participants With Anti-Anitocabtagene Autoleucel Chimeric Antigen Receptor (CAR) Antibodies (Anitocabtagene Autoleucel Arm B) | Up to 15 years | — |
| Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score | Baseline, up to 15 years | The EORTC-QLQ-C30 is a multi-item questionnaire measuring the following content: five (5) multi-item functional scales, three (3) multi-item symptom scales, six (6) single item symptoms scales, and one combined global health status/global quality of life (QoL) scale. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status /Global QoL scale indicate a higher level of functioning and a better QoL (ie, a better state of the participant), respectively, whereas higher scores in symptom scales represent a higher level of symptoms (ie, a worse state of the participant). |
| Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) - Multiple Myeloma Module (EORTC QLQ-MY20) Scores | Baseline, up to 15 years | The EORTC QLQ-MY20 has 20 items across 4 independent subscales; 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment) with a recall period of one week. Scores from each subscale are transformed from 0 to 100. For the functional scales, high scores represent improvement. For the symptom scales, higher scores represent worsening. |
| Change From Baseline in the European Quality of Life (EuroQoL) 5-Dimension 5-Level (EQ-5D-5L) Scale Index Score | Baseline, up to 15 years | The EQ-5D-5L includes a descriptive system that assesses health status across five dimensions that can be used to derive a single index score by applying a tariff based on health-state valuations. The index score typically ranges from 0 to 1, with higher values indicating better health status. |
| Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score | Baseline, up to 15 years | The EQ-5D-5L includes a VAS that assesses self-rated current health status on a scale from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"), with higher scores indicating better self-rated health. |
| Percentages of Participants Responses for Patient Global Impression Scale - Severity (PGI-S) | Up to 15 years | The PGI-S is a single-item measure that assesses a patient's perception of disease symptom severity at a point in time using a 5-point response scale ranging from "none" to "very severe." |
| Percentages of Participants Responses for Patient Global Impression Scale Change (PGI-C) | Up to 15 years | The PGI-C is a single-item measure that evaluates patients' perceptions of change in their symptoms over time using a 7-point response scale ranging from "very much worse" to "very much improved." |
| Percentages of Participants Responses for Functional Assessment of Cancer Therapy Item GP5 (FACT-GP5) | Up to 15 years | The FACT-GP5 is a single-item question for assessing global treatment side effect bother from a patient's perspective ranging from "not at all" to "very much." |
| Percentage of Participants With Hospitalizations | Up to 15 years | — |
| Mean Number of Inpatient Days per Hospitalizations | Up to 15 years | — |
| Mean Number of Intensive Care Unit Days per Hospitalizations | Up to 15 years | — |
| Percentage of Participants by Reason for Hospitalization | Up to 15 years | — |
Contacts
CONTACTMedical Information
STUDY_DIRECTORKite Study Director
Kite, A Gilead Company
Outcome results
None listed