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Monoclonal Antibodies
Pembrolizumab + Radiation Therapy for Multiple Myeloma
Phase 1
Waitlist Available
Led By Mohammad K. Khan, MD, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Relapsed and/or refractory myeloma with no minimum or maximum number of previous therapies
Candidate for radiotherapy as determined by treatment physician with symptomatic and/or asymptomatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months after study start
Awards & highlights
Study Summary
This trial studies the side effects of pembrolizumab and radiation therapy in treating patients with stage I-III multiple myeloma.
Who is the study for?
This trial is for adults with stage I-III multiple myeloma that has returned or isn't responding to treatment. They should be able to consent, have an ECOG score of 0-1, and be eligible for radiation therapy. Women must use birth control or abstain from sex, and men must also agree to contraception during the study.Check my eligibility
What is being tested?
The trial tests pembrolizumab (a monoclonal antibody) combined with radiation therapy on patients with relapsed or refractory multiple myeloma. The goal is to see if this combination is more effective in controlling cancer growth than previous treatments.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), fatigue, skin reactions from radiation, potential impact on fertility, and typical risks associated with monoclonal antibodies like infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have myeloma that has come back or hasn't responded to previous treatments, and there's no limit on the number of treatments you've had.
Select...
You are being considered for radiation therapy by your doctor for your disease, whether or not you have symptoms.
Select...
You have stage I-III multiple myeloma that is getting worse, has come back, or is not responding to treatment.
Select...
You have at least one bone or tissue growth that can be treated with radiation.
Select...
Your doctor has determined that you are a suitable candidate for pembrolizumab and your organs are working well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months after study start
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months after study start
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
Secondary outcome measures
Number of patients achieving any response
Overall response based on baseline changes on positron emission to positron emission tomography/computed tomography
Overall survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Radiation therapy, pembrolizumabExperimental Treatment2 Interventions
Patients undergo radiation therapy on day 1. Patients also receive pembrolizumab IV over 30 minutes on day 2 or 3. Courses with pembrolizumab repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,638 Previous Clinical Trials
40,929,785 Total Patients Enrolled
575 Trials studying Multiple Myeloma
189,093 Patients Enrolled for Multiple Myeloma
National Institutes of Health (NIH)NIH
2,688 Previous Clinical Trials
6,930,911 Total Patients Enrolled
16 Trials studying Multiple Myeloma
910 Patients Enrolled for Multiple Myeloma
Emory UniversityLead Sponsor
1,635 Previous Clinical Trials
2,560,105 Total Patients Enrolled
25 Trials studying Multiple Myeloma
1,952 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to carry out light physical activities like walking and taking care of yourself without help.You have myeloma that has come back or hasn't responded to previous treatments, and there's no limit on the number of treatments you've had.You are being considered for radiation therapy by your doctor for your disease, whether or not you have symptoms.You have a single tumor made of plasma cells.You have an ongoing autoimmune disease that needed strong medication in the last 2 years.You have another type of cancer that is getting worse or needs treatment, except for certain types of skin cancer.You have a history of lung inflammation that is not caused by an infection.You have an ongoing infection that needs medicine to treat.You have received treatment with certain drugs that target the PD-1 or PD-L1 proteins in the past.You have asymptomatic multiple myeloma.You have been diagnosed with HIV.You have active hepatitis B or hepatitis C.You have a condition that weakens your immune system.You have a current or past infection with tuberculosis.You are allergic to pembrolizumab or any of the ingredients in it.You have stage I-III multiple myeloma that is getting worse, has come back, or is not responding to treatment.You have at least one bone or tissue growth that can be treated with radiation.Your doctor has determined that you are a suitable candidate for pembrolizumab and your organs are working well.You have received a stem cell transplant from another person.You have a certain level of protein in your urine or blood, or abnormal results from certain tests that show the presence of myeloma.
Research Study Groups:
This trial has the following groups:- Group 1: Radiation therapy, pembrolizumab
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.
What further research has been conducted surrounding Radiation Therapy?
"Currently, there are 961 ongoing medical studies revolving around Radiation Therapy with 122 of them in their final testing phase (phase 3). While many trials take place in Houston, Texas, the total number of clinical trial sites spread across 35731 locations."
Answered by AI
To what maladies is Radiation Therapy customarily employed?
"Radiotherapy is generally used to treat malignant tumours, though it can also be helpful for those with unresectable melanoma, high microsatellite instability and disease progression after chemotherapy."
Answered by AI
How many individuals have been enrolled in the research project thus far?
"Unfortunately, this research project has concluded its recruitment process. It was originally posted on May 29th 2018 and last updated March 2nd 2022. Nevertheless, there are still 807 trials with multiple myeloma currently recruiting as well as 961 studies concerning Radiation Therapy that you can look into."
Answered by AI
Are new participants being accepted for this study?
"At this moment, no further recruitment is underway for the trial that first opened its doors on May 29th 2018. The most recent update was posted on March 2nd 2022. Alternatively, 807 trials are presently searching for patients with multiple myeloma and 961 studies utilizing radiation therapy have open enrolment periods."
Answered by AI
Has the FDA authorized Radiation Therapy for use?
"Due to the limited amount of evidence available, radiation therapy is estimated to have a safety score of 1 on our scale. This assessment was made as this experiment is currently in its first phase, with minimal data surrounding both efficacy and security."
Answered by AI
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