What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma include bortezomib, lenalidomide, carfilzomib, and dexamethasone. Known side effects of these treatments can include infections, fatigue, neuropathy, gastrointestinal issues (such as diarrhea and constipation), hypertension, and cardiac events. CAR-T therapies, like JNJ-68284528, which target B-cell maturation antigen (BCMA), may also cause cytokine release syndrome (CRS), neurotoxicity, and prolonged cytopenias. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Myeloma, including CAR-T therapies targeting cancer cells. Notably, idecabtagene vicleucel and ciltacabtagene autoleucel are CAR-T therapies directed against B-cell maturation antigen (BCMA), similar to JNJ-68284528. These therapies have shown promise in treating relapsed or refractory Multiple Myeloma by targeting and eliminating malignant cells.

What other types of research exist?

Promising novel alternatives to JNJ-68284528 for Multiple Myeloma patients in 2024 include: 1) Pomalidomide, bortezomib, and dexamethasone (as studied in the OPTIMISMM trial), 2) Carfilzomib, dexamethasone, and daratumumab (as studied in the CANDOR trial), and 3) Selinexor, bortezomib, and dexamethasone (as studied in a phase 3 trial). These combinations have shown efficacy in relapsed or refractory multiple myeloma and offer different mechanisms of action compared to CAR-T therapy.

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CAR T-cell Therapy

CAR-T Therapy for Multiple Myeloma (CARTITUDE-2 Trial)

Phase 2

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

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

Must have

Cohort B: Received one line of prior therapy including a PI and an IMiD, and disease progression per IMWG criteria less than or equal to (<=) 12 months after treatment with autologous stem cell transplantation (ASCT) or <=12 months from the start of anti-myeloma therapy for participants who have not had an ASCT

Light chain multiple myeloma in whom only measurable disease is by serum free light chain (FLC) levels in the serum: Serum immunoglobulin FLC >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio

Must not have

Cohorts A, B, C, D, E, F: Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma

Serious underlying medical condition, such as (a) evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection; (b) active autoimmune disease or a history of autoimmune disease within 3 years; (c) overt clinical evidence of dementia or altered mental status; (d) any history of Parkinson's disease or other neurodegenerative disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment called JNJ-68284528. It aims to help patients who still have small amounts of cancer cells after their initial treatment. The treatment works by finding and killing these leftover cancer cells to prevent the disease from coming back.

Who is the study for?

This trial is for multiple myeloma patients with varying treatment histories. Some must have tried specific therapies and be refractory to lenalidomide, while others may be newly diagnosed or ineligible for certain treatments due to age or comorbidities. Participants need a measurable level of disease and should be in good physical condition (ECOG grade 0-1).

What is being tested?

The study tests JNJ-68284528, a CAR-T therapy targeting BCMA, alongside other drugs like dexamethasone, lenalidomide, daratumumab, and bortezomib. It aims to assess the rate at which participants achieve minimal residual disease negativity.

What are the potential side effects?

Potential side effects include immune system reactions that can affect various organs, infusion-related responses similar to allergic reactions, fatigue from treatment exhaustion, digestive disturbances such as nausea or diarrhea, blood cell count changes leading to anemia or infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My condition worsened within 12 months after my first treatment for myeloma, which included a PI and an IMiD.

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My multiple myeloma is measured by serum free light chain levels.

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My cancer has significantly improved without getting worse, as per the latest criteria.

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I have been treated with specific drugs for my blood cancer before.

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I have high-risk newly diagnosed multiple myeloma with specific genetic features or blood test results.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My multiple myeloma has affected or previously affected my brain or spinal cord.

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You have a serious medical condition such as active infection needing strong antibiotics, uncontrolled fungal infection, active autoimmune disease, recent history of autoimmune disease, dementia, Parkinson's disease, or other brain disorders.

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I have previously received CAR-T cell therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cohorts A, B, C, D, E, and F: Percentage of Participants with Negative Minimal Residual Disease (MRD)

Cohorts G and H: Percentage of Participants with Sustained MRD Negative Complete Response (CR)

Secondary study objectives

Cohorts A, B, C, D, E, and F: Clinical Benefit Rate (CBR)

Cohorts A, B, C, D, E, and F: Levels of B-Cell Maturation Antigen (BCMA) Expressing Cells and Soluble BCMA

Cohorts A, B, C, D, E, and F: Levels of JNJ-68284528 T Cell Expansion (proliferation), and Persistence

+20 more

Side effects data

From 2022 Phase 1 & 2 trial • 126 Patients • NCT03548207

100%

Neutropenia

90%

Cytokine Release Syndrome

86%

Thrombocytopenia

76%

Anaemia

69%

Leukopenia

55%

Lymphopenia

34%

Diarrhoea

34%

Aspartate Aminotransferase Increased

31%

Upper Respiratory Tract Infection

31%

Alanine Aminotransferase Increased

28%

Cough

24%

Constipation

21%

Nausea

21%

Fatigue

21%

Hypoalbuminaemia

21%

Hypophosphataemia

17%

Vomiting

17%

Headache

14%

Arthralgia

14%

Pain in Extremity

14%

Dizziness

14%

Dyspnoea Exertional

14%

Nasal Congestion

10%

Decreased Appetite

10%

Asthenia

10%

Chills

10%

Oedema Peripheral

10%

Weight Decreased

10%

Hypokalaemia

10%

Dyspnoea

10%

Erythema

10%

Hypertension

Pneumonia

Anxiety

Peripheral Sensory Neuropathy

Abdominal Pain

Malaise

Pain

Pyrexia

Hyperbilirubinaemia

Rhinovirus Infection

Sinusitis

Blood Alkaline Phosphatase Increased

Gamma-Glutamyltransferase Increased

Serum Ferritin Increased

Weight Increased

Hypercalcaemia

Hypocalcaemia

Hyponatraemia

Muscle Spasms

Muscular Weakness

Musculoskeletal Pain

Immune Effector Cell-Associated Neurotoxicity Syndrome

Memory Impairment

Parosmia

Insomnia

Pollakiuria

Oropharyngeal Pain

Pruritus

Rash

Rash Maculo-Papular

Hypotension

Neuropathy Peripheral

Rhinorrhoea

Tremor

Productive Cough

Hypoxia

Febrile Neutropenia

Gait Disturbance

Atypical Pneumonia

Cytomegalovirus Viraemia

Gastroenteritis Cryptosporidial

Gastroenteritis Salmonella

Influenza

Sepsis

Cognitive Disorder

Facial Paralysis

Noninfective Encephalitis

Confusional State

Acute Kidney Injury

Pulmonary Haemorrhage

Sinus Tachycardia

Hypogammaglobulinaemia

International Normalised Ratio Increased

Hyperglycaemia

Hypomagnesaemia

Back Pain

Musculoskeletal Chest Pain

Myalgia

Dysgeusia

Pleural Effusion

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1b (US Population)

Phase 2 (US Population)

Phase 2 (Japan Population)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: JNJ-68284528Experimental Treatment5 Interventions

Single group assignment-Post lymphodepletion, JNJ-68284528 single infusion given to Part A participants: Cohort A(Progressive disease post 1-3 prior lines of therapy), Cohort B(Early relapse post front-line), Cohort C(Relapsed/refractory multiple myeloma post PI, IMiD,anti-CD38,anti-BCMA therapy), Cohort D(Less than CR post ASCT front-line therapy, some participants will receive JNJ-68284528 then lenalidomide), Cohort F(Newly diagnosed multiple myeloma \[NDMM\], standard risk \[International Staging System Stage I/II\] and post initial therapy); Cohort E(NDMM,transplant not planned,high risk disease) will first receive quadruplet induction regimen of daratumumab,bortezomib,lenalidomide and dexamethasone(D-VRd) then lymphodepletion and JNJ-68284528 then consolidation regimen of lenalidomide. Part B:Cohort G(NDMM,transplant not planned) will receive daratumumab, lenalidomide and dexamethasone followed by cilta-cel; Cohort H(NDMM,transplant-eligible) will receive D-VRd followed by cilta-cel.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

JNJ-68284528

2018

Completed Phase 2

~130

Lenalidomide

2005

Completed Phase 3

~2240

Bortezomib

2005

Completed Phase 3

~1410

Daratumumab

2014

Completed Phase 3

~2380

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Myeloma treatments include CAR-T cell therapy, proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies. CAR-T cell therapy, such as JNJ-68284528, involves modifying a patient's T cells to target and destroy cancer cells expressing specific antigens like BCMA. Proteasome inhibitors (e.g., bortezomib) disrupt protein degradation in cancer cells, leading to cell death. Immunomodulatory drugs (e.g., lenalidomide) enhance the immune response against myeloma cells and inhibit their growth. Monoclonal antibodies (e.g., daratumumab) target specific proteins on myeloma cells, marking them for destruction by the immune system. These treatments are crucial as they offer targeted approaches to eliminate cancer cells, improve patient outcomes, and manage the disease more effectively.