To Evaluate Safety and Efficacy of Anitocabtagene Autoleucel Versus Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma

Browse trials for

• Multiple Myeloma 3,717

Keywords

• Multiple Myeloma
• CAR-T
• ddBCMA
• BCMA

Multiple Myeloma

3,717 studies on the registry are indexed under Multiple Myeloma; 754 are open to participants now.

This study's planned enrollment of 750 is above the median of 41 across 2,967 interventional studies indexed under Multiple Myeloma.

Lead sponsor

Kite, A Gilead Company is the lead sponsor of 40 studies on the registry; 8 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.

First submitted after Kite became part of Gilead Sciences.

Eligibility criteria

Study arms

• Active comparator
  Arm A: Standard of Care Therapy (SOCT)

  Participants will receive a total of three induction therapy cycles, 42 days for each cycle, with isatuximab, bortezomib, lenalidomide and dexamethasone. Following induction, participants will receive high dose conditioning therapy with melphalan and autologous stem cell transplantation (auto-SCT). Following auto-SCT, participants will receive maintenance therapy with isatuximab and lenalidomide during 28-day cycles for up to 36 cycles or until unacceptable toxicity, disease progression per IMWG criteria, or withdrawal of consent, whichever occurs first.

  Drug: Isatuximab · Drug: Bortezomib · Drug: Lenalidomide · Drug: Dexamethasone · Drug: Melphalan

• Experimental
  Arm B: Anitocabtagene Autoleucel

  Participants will receive a total of three induction therapy cycles, 42 days for each cycle, with isatuximab, bortezomib, lenalidomide and dexamethasone. Following induction, participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine for 3 days, followed by a single infusion of anitocabtagene autoleucel. Following anitocabtagene autoleucel, participants will receive maintenance therapy with isatuximab and lenalidomide during 28-day cycles for up to 36 cycles or until unacceptable toxicity, disease progression per IMWG criteria, or withdrawal of consent, whichever occurs first.

  Drug: Anitocabtagene Autoleucel · Drug: Isatuximab · Drug: Bortezomib · Drug: Lenalidomide · Drug: Dexamethasone · Drug: Fludarabine · Drug: Cyclophosphamide

Interventions

• DrugAnitocabtagene Autoleucel

  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)

Primary outcomes

1. Minimal Residual Disease (MRD)-Negative Complete Response (CR) or Stringent CR (sCR) Rate at 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).

   Time frame: Up to 12 months

2. Progression-Free Survival (PFS)

   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.

   Time frame: Up to 15 years

Secondary outcomes

1. Overall survival (OS)

   OS is defined as the time from randomization to death due to any cause.

   Time frame: Up to 15 years

2. Overall Response Rate (ORR)

   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.

   Time frame: Up to 15 years

3. Rate of Very Good Partial Response or Better

   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.

   Time frame: Up to 15 years

4. Rate of CR or Better

   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 frame: Up to 15 years

5. Time to Response (TTR)

   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.

   Time frame: Up to 15 years

6. Duration of response (DOR)

   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 frame: Up to 15 years

7. Time to Progression (TTP)

   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.

   Time frame: Up to 15 years

8. Percentage of Participants Experiencing Serious Adverse Events (SAEs)

   Time frame: Enrollment up to 15 years

9. Percentage of Participants Experiencing Adverse Events (AEs)

   Time frame: Enrollment up to 15 years

10. Percentage of Participants With Anti-Anitocabtagene Autoleucel Chimeric Antigen Receptor (CAR) Antibodies (Anitocabtagene Autoleucel Arm B)

    Time frame: Up to 15 years

11. Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score

    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).

    Time frame: Baseline, up to 15 years

12. Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) - Multiple Myeloma Module (EORTC QLQ-MY20) Scores

    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.

    Time frame: Baseline, up to 15 years

13. Change From Baseline in the European Quality of Life (EuroQoL) 5-Dimension 5-Level (EQ-5D-5L) Scale Index Score

    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.

    Time frame: Baseline, up to 15 years

14. Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score

    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.

    Time frame: Baseline, up to 15 years

15. Percentages of Participants Responses for Patient Global Impression Scale - Severity (PGI-S)

    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."

    Time frame: Up to 15 years

16. Percentages of Participants Responses for Patient Global Impression Scale Change (PGI-C)

    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."

    Time frame: Up to 15 years

17. Percentages of Participants Responses for Functional Assessment of Cancer Therapy Item GP5 (FACT-GP5)

    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."

    Time frame: Up to 15 years

18. Percentage of Participants With Hospitalizations

    Time frame: Up to 15 years

19. Mean Number of Inpatient Days per Hospitalizations

    Time frame: Up to 15 years

20. Mean Number of Intensive Care Unit Days per Hospitalizations

    Time frame: Up to 15 years

21. Percentage of Participants by Reason for Hospitalization

    Time frame: Up to 15 years

Individual participant data

Plan to share: No