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CAR-T Therapy for Multiple Myeloma (CARTITUDE-4 Trial)
Phase 3
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
Be refractory to lenalidomide per IMWG consensus guidelines
Measurable disease at screening as defined by specific criteria related to serum monoclonal paraprotein (M-protein) level or urine M-protein level, or light chain multiple myeloma without measurable M-protein
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until end of the study (up to 6 years)
Awards & highlights
CARTITUDE-4 Trial Summary
This trial will compare the effectiveness of an experimental drug with a standard drug regimen for myeloma.
Who is the study for?
This trial is for people with multiple myeloma who've had 1-3 prior treatments including specific drugs, are lenalidomide-refractory, and meet certain lab value criteria. Not eligible if they've had CAR-T or BCMA-targeted therapies, recent high-dose steroids, antibody treatment within 21 days, chemotherapy within 14 days, or have unresolved severe side effects from past cancer therapy.Check my eligibility
What is being tested?
The study compares JNJ-68284528 (a CAR-T cell therapy targeting BCMA) against standard therapies: PVd (Pomalidomide with Bortezomib and Dexamethasone) or DPd (Daratumumab with Pomalidomide and Dexamethasone), to see which is more effective for relapsed multiple myeloma patients.See study design
What are the potential side effects?
CAR-T therapy can cause immune system reactions like fever and low blood pressure. Standard treatments may lead to nerve damage, fatigue, infection risk increase due to lowered white blood cell counts, bleeding issues from low platelets count, and possible heart complications.
CARTITUDE-4 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition did not improve after taking lenalidomide.
Select...
My cancer can be measured by specific protein levels in my blood or urine.
Select...
I've had 1-3 treatments before that included a PI and an IMiD.
CARTITUDE-4 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until end of the study (up to 6 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until end of the study (up to 6 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score
Change from Baseline in Health-Related Quality of Life as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score
Change from Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Sore
+15 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%
Hypertension
22%
Alanine Aminotransferase Increased
21%
Oedema Peripheral
21%
Dizziness
21%
Headache
21%
Constipation
21%
Vomiting
18%
Hypomagnesaemia
18%
Sinus Tachycardia
18%
Blood Lactate Dehydrogenase Increased
18%
Hypotension
16%
Arthralgia
16%
Immune Effector Cell-Associated Neurotoxicity Syndrome
16%
Nasal Congestion
16%
Gamma-Glutamyltransferase Increased
16%
Hypogammaglobulinaemia
16%
Hypofibrinogenaemia
16%
Insomnia
15%
Blood Alkaline Phosphatase Increased
15%
Pain in Extremity
13%
Back Pain
12%
Rhinorrhoea
12%
Dyspnoea
12%
International Normalised Ratio Increased
12%
Hyperglycaemia
10%
Flushing
10%
Muscular Weakness
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%
Pneumonia
6%
Influenza
6%
Confusional State
6%
Wheezing
6%
Dysgeusia
6%
Sepsis
6%
Sinus Bradycardia
6%
Activated Partial Thromboplastin Time Prolonged
6%
Musculoskeletal Chest Pain
6%
Hypoglycaemia
6%
Tremor
6%
Productive Cough
6%
Musculoskeletal Pain
6%
Micrographia
6%
Deep Vein Thrombosis
4%
Oropharyngeal Pain
4%
Mental Status Changes
4%
Parkinsonism
4%
Peripheral Sensory Neuropathy
3%
Rhinovirus Infection
3%
Pain
3%
Muscle Spasms
3%
Hypoxia
3%
Memory Impairment
3%
Acute Kidney Injury
3%
Neurotoxicity
3%
Asthenia
3%
Sinusitis
3%
Weight Decreased
3%
Dyspnoea Exertional
1%
Haematochezia
1%
Bacteraemia
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%
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%
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-4 Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])Experimental Treatment1 Intervention
Participants will receive at least one cycle of bridging therapy (PVd or DPd) and additional cycles of bridging therapy may be considered based on participant's clinical status and timing of availability of JNJ-68284528 (cilta-cel) along with conditioning regimen (cyclophosphamide 300 milligram [mg]/m^2 intravenous [IV] and fludarabine 30 mg/m^2 IV daily, for 3 days), and JNJ-68284528 (cilta-cel) infusion 0.75 * 10^6 chimeric antigen receptor (CAR)-positive viable T cells/ kilogram (kg).
Group II: Arm A: PVd or DPd (Standard Therapy)Experimental Treatment4 Interventions
Participants will receive either PVd or DPd as a standard therapy. In PVd treatment, participants will receive oral pomalidomide 4 mg on Days 1 to 14 in each cycle; bortezomib 1.3 mg/meter square (m^2) SC on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each cycle will consist of 21 days. In DPd treatment, participants will receive daratumumab SC 1800 mg weekly on Days 1, 8, 15, and 22 (Cycles 1 and 2), every 2 weeks on Days 1 and 15 (Cycles 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); oral pomalidomide 4 mg on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg oral or IV weekly on Days 1, 8, 15, and 22 (Cycle 1 onwards). Each cycle will consist of 28 days. Participants will continue to receive PVd or DPd until confirmed PD, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs earlier.
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
Dexamethasone
2007
Completed Phase 4
~2590
Daratumumab
2014
Completed Phase 3
~1860
Pomalidomide
2011
Completed Phase 2
~1020
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,889 Total Patients Enrolled
70 Trials studying Multiple Myeloma
18,998 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,486 Total Patients Enrolled
49 Trials studying Multiple Myeloma
13,965 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken a lot of steroids, like prednisone, recently.I do not have severe nerve pain or damage.I have not received monoclonal antibody treatment in the last 21 days.I haven't had chemotherapy in the last 14 days.My side effects from past cancer treatments are mild or gone, except for hair loss.I haven't taken proteasome inhibitor drugs in the last 14 days.My myeloma has worsened within 6 months after my last treatment.I have not taken immunomodulatory drugs in the last 7 days.My condition did not improve after taking lenalidomide.Your recent medical tests must show specific results.My cancer can be measured by specific protein levels in my blood or urine.I've had 1-3 treatments before that included a PI and an IMiD.I have received treatments targeting BCMA.I have previously undergone CAR-T cell therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: PVd or DPd (Standard Therapy)
- Group 2: Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])
Awards:
This trial has 2 awards, including:- 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.
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.
Does JNJ-68284528 have a history of being tested in other medical studies?
"JNJ-68284528 was first researched in 2002 by the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. As of now, there have been a total of 1433 completed clinical trials worldwide. Out of these, 691 are presently active, many within Phoenix, Arizona."
Answered by AI
Is this trial being run in a significant number of clinics across Canada?
"There are 19 clinical trial sites currently operational. These locations include Phoenix, Durham and Miami. To reduce the amount of travel required, patients are encouraged to choose a site that is nearest to them."
Answered by AI
How many patients are eligible to participate in this clinical trial?
"Presently, this study is not looking for any new participants. The trial was first posted on June 12th 2020 and updated November 3rd 2022. If you are interested in other studies, 826 clinical trials involving multiple myeloma and 691 trials testing JNJ-68284528 are actively recruiting patients."
Answered by AI
What is the status of JNJ-68284528 in terms of federal approval?
"JNJ-68284528 is a Phase 3 drug, meaning that while there is some efficacy data, there are multiple rounds of safety data. Therefore, it receives a score of 3 from our team at Power."
Answered by AI
What are the primary medical conditions that JNJ-68284528 has been shown to be effective for?
"JNJ-68284528 can be used to mediate ophthalmia, sympathetic, branch retinal vein occlusion, and macular edema."
Answered by AI
Are there still openings available for people who want to participate in this research project?
"This study has completed recruitment for participants. The clinical trial was first posted on 6/12/2020 and most recently updated on 11/3/2022. If you are searching for other studies, 826 trials are actively enrolling patients with multiple myeloma and 691 studies are admitting JNJ-68284528 patients."
Answered by AI
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