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CAR T-cell Therapy
CAR T-Cell Therapy for Multiple Myeloma
Phase 2
Recruiting
Led By Irene Ghobrial, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women of childbearing potential must have a negative pregnancy test at screening and agree to practice a highly effective method of contraception
Age > 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial tests if cilta-cel, with cyclophosphamide and fludarabine, can safely and effectively treat high-risk, smoldering myeloma.
Who is the study for?
This trial is for adults over 18 with high-risk smoldering myeloma, which isn't yet causing symptoms. Participants should have certain blood and bone marrow conditions but no recent other cancers or major illnesses. They must be able to perform daily activities with ease (ECOG PS 0 or 1) and agree to use effective contraception.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of cilta-cel, a CAR T-cell therapy, along with cyclophosphamide and fludarabine phosphate chemotherapies in treating high-risk smoldering myeloma before it becomes symptomatic.See study design
What are the potential side effects?
Possible side effects include immune system reactions due to cilta-cel, as well as typical chemotherapy-related issues like nausea, hair loss, fatigue, increased infection risk from cyclophosphamide and fludarabine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and agree to use effective birth control.
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I am older than 18 years.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events (AEs)
Incidence of Dose Limiting Toxicities (DLT)
Nature of Dose Limiting Toxicities (DLT)
Secondary outcome measures
AUC of BCMA CAR-T cells
Clast of BCMA CAR-T cells
Cmax of BCMA CAR-T Cells
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Safety Run-InExperimental Treatment3 Interventions
Participants will be enrolled into each of the 2 safety run-in phases in a standard 3 + 3 design.
- Participants will undergo study procedures as outlined:
Apheresis for collection of peripheral blood mononuclear cells (PBMC) will occur on-site
Stem cell collection on-site post-apheresis per standard care.
Administration of Cyclophosphamide and fludarabine in pre-determined doses 1 x daily for 3 consecutive days.
Hospitalization to receive Cilta-cel in per-determined dose per protocol 1 x daily for 3 consecutive days and will remain in the hospital for 2 weeks post cilta-cell infusion.
Follow-up for 3 years post-treatment and up to 15 years.
Group II: Cilta-Cel Dose Expansion CohortExperimental Treatment3 Interventions
Expansion cohort of 14 participants will be enrolled after safety run-in phases, and participants will undergo study procedures as outlined:
Apheresis for collection of peripheral blood mononuclear cells (PBMC) will occur on-site
Stem cell collection on-site post-apheresis per standard care.
Administration of Cyclophosphamide and fludarabine in pre-determined doses 1 x daily for 3 consecutive days.
Hospitalization to receive Cilta-cel in per-determined dose per protocol 1 x daily for 3 consecutive days and will remain in the hospital for 2 weeks post cilta-cell infusion.
Follow-up for 3 years post-treatment and up to 15 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,960 Total Patients Enrolled
51 Trials studying Multiple Myeloma
34,302 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLCIndustry Sponsor
975 Previous Clinical Trials
6,384,340 Total Patients Enrolled
70 Trials studying Multiple Myeloma
19,442 Patients Enrolled for Multiple Myeloma
Irene Ghobrial, MDPrincipal InvestigatorDana-Farber Cancer Institute
11 Previous Clinical Trials
32,055 Total Patients Enrolled
7 Trials studying Multiple Myeloma
31,870 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 2 weeks.I am not allergic or intolerant to the study drug or its components.I do not have any unmanaged ongoing illnesses.I haven't had myelodysplastic syndrome or cancer in the last 2 years.I am a man and will use protection if I have sex with a woman who can have children.I have a heart condition.You have a high percentage of certain bone marrow cells and specific changes in their patterns.I have been treated with specific therapies before or am currently receiving them.I am positive for HIV, HBV, HCV, or COVID-19.My condition is high-risk smoldering multiple myeloma with ≤40% plasma cells.I am not pregnant and agree to use effective birth control.Certain test results taken less than 28 days before signing up.My multiple myeloma has spread to my brain or spinal cord.I am older than 18 years.I am not currently receiving any experimental treatments.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had or been treated for another cancer within the last 2 years.I have received treatment specifically for smoldering multiple myeloma.I have symptoms of multiple myeloma or meet the CRAB criteria.I do not have any health or mental conditions that could affect the study.
Research Study Groups:
This trial has the following groups:- Group 1: Safety Run-In
- Group 2: Cilta-Cel Dose Expansion Cohort
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 participants in the Safety Run-In study adequately protected?
"The safety of Safety Run-In is provisionally rated a 2, as there are evidence suggesting its protection but none that confirm its effectiveness."
Answered by AI
Is there still availability for participants in this investigation?
"Clinicaltrials.gov data suggests that this study, which began on the 1st of May 2023 and was last updated on March 2nd 2023, is not actively recruiting for participants. However, 807 other trials are currently searching for patients to join their clinical research."
Answered by AI
What are the core aims of this research endeavor?
"This clinical trial will take approximately 24 months to evaluate Nature of Dose Limiting Toxicities (DLT) and measure a variety of secondary outcomes. These include Overall Response Rate (ORR), defined as the proportion of participants with the best possible response, Complete Response Rate which is determined by local investigators using International Myeloma Working Group Criteria (Kumar et al, 2016), and Duration of Response, measured from when an individual achieves their desired result until relapse or death due to multiple myeloma occurs."
Answered by AI
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