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Monoclonal Antibodies
PD-1 Blockade + Dendritic Cell Fusion Vaccine + CT-011 for Multiple Myeloma
Phase 2
Waitlist Available
Led By David Avigan, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is testing the safety of CT-011 and the combination of the Dendritic cell fusion vaccine and CT-011 after ASCT in patients with multiple myeloma. They are also testing to see if the combination is more successful in preventing or delaying the disease from coming back, compared to treatment with ASCT alone.
Who is the study for?
This trial is for adults over 18 with multiple myeloma who are candidates for high-dose chemotherapy and stem cell rescue. They must have a certain level of heart function, specific lab results, measurable disease, and no serious illnesses like significant heart disease or active infections. Pregnant women or those with autoimmune diseases (except stable hypothyroidism) can't join.
What is being tested?
The study is testing the safety and effect of CT-011 alone and combined with a dendritic cell fusion vaccine after autologous stem cell transplantation in multiple myeloma patients. It aims to see if this combination helps prevent or delay cancer recurrence better than standard therapy.
What are the potential side effects?
Possible side effects include reactions related to the immune system since CT-011 targets immune cells, which could lead to inflammation in various organs. As an investigational drug, there may be unknown risks as well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Active Control
Group I: Group 1Active Control1 Intervention
Monoclonal antibody CT-011 will be given 1-3 months following autologous transplant. 3 doses will be given at 6 week intervals.
Group II: Group 2Active Control2 Interventions
Vaccination with DC/myeloma fusion cells will be given 1-3 months following autologous transplant. Vaccination will be given at 6 weeks intervals. The monoclonal antibody CT-011 will be given 1 week following each vaccination. 3 doses of CT-011 will be given at 6 week intervals.
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Who is running the clinical trial?
United States Department of DefenseFED
891 Previous Clinical Trials
332,443 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,653 Previous Clinical Trials
11,491,000 Total Patients Enrolled
13 Trials studying Multiple Myeloma
945 Patients Enrolled for Multiple Myeloma
Beth Israel Deaconess Medical CenterLead Sponsor
848 Previous Clinical Trials
12,930,069 Total Patients Enrolled
13 Trials studying Multiple Myeloma
1,095 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's pumping ability is greater than 45%.Your test results need to match the study's requirements.You have had a serious blood clot in a vein in the past.You have a serious autoimmune disease.You have HIV.You have a serious illness like a severe infection needing IV antibiotics, or a major heart condition with significant heart rhythm problems, heart artery blockages, or heart failure.You have had a bone marrow or stem cell transplant from someone else.Patients with multiple myeloma who may be considered for intensive chemotherapy followed by stem cell transplant.You are in good enough health to carry out daily activities and have a life expectancy of more than nine weeks.You have more than 20% of your bone marrow affected by plasmacytoma that can be removed with local anesthesia.You cannot have any active or past autoimmune diseases like Type I diabetes, Type II diabetes, vitiligo, or stable hypothyroidism.You have a history of an elevated M component in your blood or urine.Your lung function is good, with a DLCO (adjusted) of more than 50%.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
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.
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