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CAR T-cell Therapy

Anitocabtagene Autoleucel for Multiple Myeloma (iMMagine-3 Trial)

Phase 3

Recruiting

Research Sponsored by Kite, A Gilead Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented historical diagnosis of multiple myeloma (MM)

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

"This trial aims to compare a new drug, anitocabtagene autoleucel, with standard treatment for patients with relapsed/refractory multiple myeloma. The main goal is to

Who is the study for?

This trial is for people with relapsed/refractory multiple myeloma who've had 1-3 prior treatments including an anti-CD38 antibody and an immunomodulatory drug. They should have measurable disease indicators, be able to receive one of the standard therapies, and have good physical function (ECOG status 0 or 1). Women must not be pregnant and if of childbearing potential, need a negative pregnancy test.

What is being tested?

The study compares anitocabtagene autoleucel (a new therapy) against standard of care options like Bortezomib or Carfilzomib combinations in participants with multiple myeloma. It measures how long patients live without their disease getting worse by using independent reviews.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fever, fatigue, infusion-related reactions; blood cell count changes; increased risk of infections; and organ-specific inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with multiple myeloma.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am not pregnant and cannot become pregnant, either through surgery or because I have been postmenopausal for 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-Free Survival (PFS)

Secondary study objectives

Change From Baseline in the EORTC - Multiple Myeloma Module (EORTC QLQ-MY20) Score

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

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

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Anitocabtagene AutoleucelExperimental Treatment3 Interventions

Participants with RRMM will receive lymphodepletion chemotherapy with cyclophosphamide and fludarabine for 3 days followed by single dose of anitocabtagene autoleucel chimeric antigen receptor positive (CAR+) on Day 1.

Group II: Standard of Care Therapy (SOCT)Active Control5 Interventions

Participants will receive the investigator's choice of one of the following therapies: * pomalidomide, bortezomib, and dexamethasone (PVd) (21-day cycles) * daratumumab, pomalidomide, and dexamethasone (DPd) (28-day cycles) * carfilzomib, daratumumab, and dexamethasone (KDd) (28-day cycles) * carfilzomib and dexamethasone (Kd) (28-day cycles)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1860