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CAR T-cell Therapy
CAR-T Therapy for Multiple Myeloma (CARTITUDE-2 Trial)
Phase 2
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
CARTITUDE-2 Trial Summary
This trial is testing a new drug to see if it can help people with blood cancer by reducing the amount of cancer cells in their body.
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).Check my eligibility
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.See study design
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.
CARTITUDE-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition worsened within 12 months after my first treatment for myeloma, which included a PI and an IMiD.
Select...
My multiple myeloma is measured by serum free light chain levels.
Select...
My cancer has significantly improved without getting worse, as per the latest criteria.
Select...
I have been treated with specific drugs for my blood cancer before.
Select...
I have high-risk newly diagnosed multiple myeloma with specific genetic features or blood test results.
Select...
I am fully active or can carry out light work.
CARTITUDE-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreSide effects data
From 2022 Phase 1 & 2 trial • 126 Patients • NCT0354820794%
Neutropenia
87%
Cytokine Release Syndrome
84%
Anaemia
75%
Thrombocytopenia
59%
Leukopenia
51%
Lymphopenia
44%
Fatigue
43%
Hypocalcaemia
38%
Cough
37%
Decreased Appetite
35%
Hypophosphataemia
31%
Nausea
31%
Hypoalbuminaemia
29%
Hyponatraemia
28%
Diarrhoea
26%
Aspartate Aminotransferase Increased
25%
Pyrexia
25%
Chills
25%
Hypokalaemia
22%
Alanine Aminotransferase Increased
22%
Hypertension
21%
Dizziness
21%
Oedema Peripheral
21%
Headache
21%
Constipation
21%
Vomiting
18%
Hypomagnesaemia
18%
Sinus Tachycardia
18%
Blood Lactate Dehydrogenase Increased
18%
Hypotension
16%
Immune Effector Cell-Associated Neurotoxicity Syndrome
16%
Gamma-Glutamyltransferase Increased
16%
Hypogammaglobulinaemia
16%
Hypofibrinogenaemia
16%
Arthralgia
16%
Insomnia
16%
Nasal Congestion
15%
Blood Alkaline Phosphatase Increased
15%
Pain in Extremity
13%
Back Pain
12%
Rhinorrhoea
12%
Dyspnoea
12%
International Normalised Ratio Increased
12%
Hyperglycaemia
10%
Muscular Weakness
10%
Flushing
9%
Febrile Neutropenia
9%
Abdominal Pain
9%
Upper Respiratory Tract Infection
7%
Serum Ferritin Increased
7%
Dehydration
7%
Pleural Effusion
7%
Epistaxis
7%
Anosmia
7%
Myalgia
6%
Wheezing
6%
Dysgeusia
6%
Pneumonia
6%
Sepsis
6%
Sinus Bradycardia
6%
Influenza
6%
Activated Partial Thromboplastin Time Prolonged
6%
Musculoskeletal Chest Pain
6%
Hypoglycaemia
6%
Tremor
6%
Productive Cough
6%
Musculoskeletal Pain
6%
Confusional State
6%
Micrographia
6%
Deep Vein Thrombosis
4%
Mental Status Changes
4%
Parkinsonism
4%
Peripheral Sensory Neuropathy
4%
Oropharyngeal Pain
3%
Rhinovirus Infection
3%
Hypoxia
3%
Memory Impairment
3%
Acute Kidney Injury
3%
Neurotoxicity
3%
Asthenia
3%
Pain
3%
Sinusitis
3%
Weight Decreased
3%
Muscle Spasms
3%
Dyspnoea Exertional
1%
Herpes Zoster
1%
Herpes Zoster Disseminated
1%
Lung Abscess
1%
Perirectal Abscess
1%
Neuralgia
1%
Staphylococcal Infection
1%
Atrial Fibrillation
1%
Cholecystitis Acute
1%
Supraventricular Tachycardia
1%
Diplopia
1%
Haematochezia
1%
Respiratory Failure
1%
Tumour Lysis Syndrome
1%
Pericardial Effusion
1%
Skin Infection
1%
Peripheral Motor Neuropathy
1%
Bacterial Sepsis
1%
Acute Respiratory Failure
1%
Septic Shock
1%
Cranial Nerve Paralysis
1%
Somnolence
1%
Blood Creatinine Increased
1%
Syncope
1%
Bacteraemia
1%
Lymphocytosis
1%
Malaise
1%
Hyperbilirubinaemia
1%
Anxiety
1%
Pollakiuria
1%
Pruritus
1%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 (US Population)
Phase 2 (Japan Population)
Phase 1b (US Population)
CARTITUDE-2 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
JNJ-68284528
2018
Completed Phase 2
~130
Bortezomib
2005
Completed Phase 2
~1140
Lenalidomide
2005
Completed Phase 3
~1480
Daratumumab
2014
Completed Phase 3
~1860
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,139 Total Patients Enrolled
70 Trials studying Multiple Myeloma
19,248 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,736 Total Patients Enrolled
49 Trials studying Multiple Myeloma
14,215 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had 1-3 treatments for my condition, including specific therapies, and one didn't work as expected.I have newly diagnosed multiple myeloma and have undergone 4 to 8 cycles of initial treatment.My multiple myeloma has affected or previously affected my brain or spinal cord.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.I am not a candidate for high-dose chemotherapy with stem cell transplant due to age, health issues, or personal choice.My condition worsened within 12 months after my first treatment for myeloma, which included a PI and an IMiD.I have no active cancers except for certain treated or low-risk cases.If you have a score of 2 or higher on the Myeloma Geriatric Assessment, you cannot participate in Cohorts E, G, or H.I am eligible for high-dose chemotherapy with stem cell transplant as my first treatment.Your blood or urine shows high levels of a specific protein called M-protein.I am receiving or have received BCMA-targeted therapy.I have taken a high dose of steroids recently.My multiple myeloma is measured by serum free light chain levels.My cancer's presence is confirmed by PET/CT or MRI scans.I have a detectable tumor at least 1cm*1cm in size, confirmed by PET/CT or MRI.My cancer has significantly improved without getting worse, as per the latest criteria.My side effects from past cancer treatments have mostly gone away.I have previously received CAR-T cell therapy.I have been treated with specific drugs for my blood cancer before.I have high-risk newly diagnosed multiple myeloma with specific genetic features or blood test results.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: JNJ-68284528
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any extant reports concerning the use of JNJ-68284528?
"At present, there are 780 trials underway evaluating JNJ-68284528. Out of those studies, 170 are in the third phase. Although Joliet, Illinois is home to most of them, they span across 26738 different sites worldwide."
Answered by AI
What is the uppermost limit of participants in this clinical trial?
"Affirmative. Records on clinicaltrials.gov indicate that this experiment, which was first made available November 7th 2019, is still recruiting individuals for participation. A total of 157 participants will be accepted from a network of 19 different sites."
Answered by AI
In what scenarios is JNJ-68284528 most frequently prescribed?
"JNJ-68284528 has been identified as an effective treatment for ophthalmia, sympathetic, and other medical issues such as branch retinal vein occlusion, macular edema and a minimum of two prior systemic chemotherapy regimens."
Answered by AI
What is the current geographic spread of this clinical research?
"University of Pittsburgh in Pittsburgh, Pennsylvania, Mayo Clinic Rochester in Rochester, Minnesota and Levine Cancer Institute, Carolinas HealthCare Systemin Charlotte North carolina are three sites that are accepting patients for this clinical trial. Additionally there are 19 other locations participating as well."
Answered by AI
Has the FDA authorized JNJ-68284528 for use in consumers?
"Our judgement of the safety profile of JNJ-68284528 is a 2, as this Phase 2 clinical trial has only provided limited evidence regarding its safety and none to support efficacy."
Answered by AI
Are there any opportunities for individuals to still participate in this research?
"Affirmative, the information located on clinicaltrials.gov implies that this investigation is presently recruiting test subjects. This medical experiment was first uploaded to the website on November 7th 2019 and last edited on November 3rd 2022. 157 patients need to be enrolled from 19 different research facilities."
Answered by AI
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