A Trial to Evaluate Safety and Efficacy of Anitocabtagene Autoleucel Versus Standard of Care in Newly Diagnosed Multiple Myeloma

Browse trials for

• Multiple Myeloma 3,712

Keywords

• Multiple Myeloma
• CAR-T
• ddBCMA
• BCMA

Multiple Myeloma

3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.

This study's planned enrollment of 600 is above the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.

Lead sponsor

Kite, A Gilead Company is the lead sponsor of 39 studies on the registry; 9 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 eight induction therapy cycles, 21-days for each cycle, with daratumumab, bortezomib, lenalidomide and dexamethasone. Following induction, participants will receive maintenance therapy during 28-day cycles of daratumumab, lenalidomide and dexamethasone, until unacceptable toxicity, progression as per IMWG criteria, death, or participant withdrawal of consent (whichever occurs first).

  Drug: Daratumumab · Drug: Bortezomib · Drug: Lenalidomide · Drug: Dexamethasone

• Experimental
  Arm B: Anitocabtagene Autoleucel

  Participants will receive a total of eight induction therapy cycles, 21-days for each cycle, with daratumumab, bortezomib, lenalidomide and dexamethasone. Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine for 3 days, followed by a single infusion of anitocabtagene autoleucel. If specific criteria are met, some participants may receive maintenance therapy (at or after Month 6 post-anitocabtagene autoleucel infusion) during 28-day cycles of daratumumab, lenalidomide and dexamethasone, until unacceptable toxicity, progression as per IMWG criteria, death, or participant withdrawal of consent (whichever occurs first).

  Drug: Anitocabtagene autoleucel · Drug: Daratumumab · Drug: Bortezomib · Drug: Lenalidomide · Drug: Dexamethasone · Drug: Fludarabine · Drug: Cyclophosphamide

Interventions

• DrugAnitocabtagene autoleucel

  A single infusion of CAR+ transduced autologous T cells

  Also known as: CART-ddBCMA

• DrugDaratumumab

  Administered subcutaneously (SC)

• DrugBortezomib

  Administered SC

• DrugLenalidomide

  Administered orally (PO)

• DrugDexamethasone

  Administered PO or intravenously (IV)

• DrugFludarabine

  Administered IV

• DrugCyclophosphamide

  Administered 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: 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)

   Time to response 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 (Kumar 2016) 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

   Time to progression (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. Duration of Treatment-Free Interval

   Duration of treatment-free interval is defined as time from date of anitocabtagene autoleucel infusion to date of initiation of maintenance therapy.

   Time frame: Up to 15 years

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

   Time frame: Enrollment up to 15 years

10. Percentage of Participants Experiencing Adverse Events (AEs)

    Time frame: Enrollment up to 15 years

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

    Time frame: Up to 15 years

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

    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 5 years

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

    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 5 years

14. Change From Baseline in the European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ-5D-5L) Scale index Score and VAS Scale Score

    The EuroQol EQ-5D-5L questionnaire is a generic measure of health status with two components: the EQ-5D descriptive system and the EQ visual analog scale (VAS). The descriptive system can be used to estimate a single index value through application of a tariff of values based on direct valuations of health. The index typically ranges from 0 to 1 where a higher score indicates a better outcome. The VAS is a 20-cm VAS for recording self-rated current HRQoL state where a score of 0 represents ("the worst health you can imagine") and a score of 100 represents ("the best health you can imagine").

    Time frame: Baseline, up to 5 years

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

    The PGI-S is a 5-point, single-item measure that assesses a patient's perception of disease symptom severity at a point in time.

    Time frame: Screening, up to 1 year

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

    The PGI-C is a 7-point, single-item measure that evaluates patients' perceptions of change in their symptoms over time.

    Time frame: Screening, up to 1 year

17. Percentages of Participants With 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.

    Time frame: Screening, up to 2 years

18. Percentage of Participants Hospitalizations, Inpatient Days, Intensive Care Unit Days, and Reasons for Hospitalization

    Time frame: Up to 15 years

Individual participant data

Plan to share: No