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PD-1 Inhibitor
Pembrolizumab for Multiple Myeloma
Phase 2
Waitlist Available
Research Sponsored by Alfred Chung, MD
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 2 years
Awards & highlights
Study Summary
This trial is testing whether pembrolizumab can shrink tumors in patients with multiple myeloma who have relapsed or who did not respond to previous treatment with anti-BCMA CAR-T therapies.
Who is the study for?
This trial is for adults with multiple myeloma that has returned or didn't respond to anti-BCMA CAR-T therapy. Participants must be in relatively good health (ECOG < 2), not pregnant, and agree to use contraception. They should have tried other treatments like proteasome inhibitors without success and can't have used certain immune therapies before.Check my eligibility
What is being tested?
The trial is testing Pembrolizumab, an immunotherapy drug, on patients whose multiple myeloma has relapsed or is refractory after anti-BCMA CAR-T treatment. It's a phase II study aiming to see if this drug can shrink tumors by boosting the immune system.See study design
What are the potential side effects?
Pembrolizumab may cause side effects such as fatigue, skin reactions, inflammation of organs like lungs (pneumonitis), hormonal gland problems (like thyroid issues), infusion-related reactions, and it could potentially worsen autoimmune diseases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate(ORR)
Secondary outcome measures
Cumulative incidence function for Time to next treatment (TNT)
Median Duration of Response (DOR)
Median Overall Survival (OS) at 12 months
+7 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab)Experimental Treatment1 Intervention
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 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
Find a Location
Who is running the clinical trial?
Alfred Chung, MDLead Sponsor
1 Previous Clinical Trials
46 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,971 Total Patients Enrolled
37 Trials studying Multiple Myeloma
11,417 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant, as confirmed by a recent urine test.You have previously been treated with a specific type of medication that affects the immune system.You have received a certain type of cell therapy less than 90 days before starting this study.You have received other cancer treatments after getting anti-BCMA CAR-T therapy.You are able to perform everyday activities without help.You have a condition that weakens your immune system or you have been taking strong medications that lower your immune system within the past week.You had another type of cancer within the past 2 years, unless you finished treatment that could cure it.You have cancer that has spread to your brain or spinal cord.You have a severe allergic reaction (grade 3 or higher) to pembrolizumab or any of its ingredients.You have a condition where your immune system attacks your own body and needed strong medication for it in the past 2 years.You have had lung inflammation in the past that needed steroids, or you currently have lung inflammation.You have an infection that needs treatment throughout your body.You have a history of HIV, Hepatitis B or C virus infection, or active tuberculosis.You have a history of mental health issues or substance abuse.You have received a transplant from another person.Your multiple myeloma cannot be measured through blood or urine tests.You have been diagnosed with Waldenstrom's disease, light chain amyloidosis, or POEMS disease.You have a physical performance level of 2 or higher.You are a man or woman who is at least 18 years old and has been diagnosed with multiple myeloma through tissue sample testing.Your disease got worse after having a certain type of CAR-T therapy for BCMA.You are not eligible for treatments that are known to help with multiple myeloma.You have received and couldn't tolerate certain types of medications for your condition in the past.You have symptoms of multiple myeloma and specific medical events related to the disease.Your organs must be working properly according to specific blood test results.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (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.
Are there any vacancies in this trial for potential participants?
"This clinical trial, which was first posted on 5/3/2022 and most recently edited on 8/9/2022, is actively looking for patients."
Answered by AI
Do you have any insight into Pembrolizumab's clinical trial history?
"There are currently 1000 ongoing clinical trials researching Pembrolizumab. 122 of those are in Phase 3 and 36030 locations are running studies for this treatment."
Answered by AI
How many individuals are presently being helped by this clinical trial?
"That is correct. The clinical trial mentioned is still recruiting patients, as indicated by the information found on clinicaltrials.gov. This specific study was first posted on May 3rd, 2022 and was most recently edited on August 9th, 2022. So far, 25 patients have been recruited from 1 location."
Answered by AI
What are the most common reasons that Pembrolizumab is given to patients?
"Pembrolizumab is the standard of care for malignant neoplasms. In addition, this immunotherapy medication can also improve quality of life for patients with unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."
Answered by AI
Has Pembrolizumab received clearance from the FDA?
"Pembrolizumab is still being tested for efficacy in Phase 2 trials, but there is some data supporting its safety which gives it a score of 2."
Answered by AI
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