Your session is about to expire
← Back to Search
PD-1 Inhibitor
Pembrolizumab for Multiple Myeloma
Phase 2
Recruiting
Led By Ajay K Nooka, MD,MPH,FACP
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Male patients, even if surgically sterilized, must agree to practice effective barrier contraception or true abstinence
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial will test the effect of pembrolizumab on patients with multiple myeloma who are progressing on CAR-T cell therapy.
Who is the study for?
This trial is for adults with multiple myeloma that's getting worse despite CAR-T cell therapy. They must be in good physical condition, not have severe kidney or liver issues, no recent major surgeries, and can't be pregnant or breastfeeding. Participants need to agree to use effective contraception and should not have had certain other treatments recently.Check my eligibility
What is being tested?
The trial is testing pembrolizumab as a salvage therapy for patients whose multiple myeloma has progressed after CAR-T cell treatment. It's a phase II study focusing on how well this monoclonal antibody helps the immune system fight cancer cells and stop their growth.See study design
What are the potential side effects?
Pembrolizumab may cause side effects like fatigue, skin reactions, inflammation of organs such as lungs (pneumonitis), hormonal gland problems (like thyroid dysfunction), infusion-related reactions, and it could potentially worsen existing infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
I am a male and agree to use effective contraception or practice abstinence.
Select...
I am not pregnant and agree to use birth control.
Select...
I had BCMA CAR-T cell therapy and my cancer has worsened.
Select...
I have been diagnosed with multiple myeloma according to IMWG 2014 criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Immunogenicity of the salvage regimen
Incidence of adverse events (AEs)
Overall survival (OS)
+1 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
FDA approved
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,639 Previous Clinical Trials
2,560,616 Total Patients Enrolled
25 Trials studying Multiple Myeloma
1,949 Patients Enrolled for Multiple Myeloma
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,059,905 Total Patients Enrolled
37 Trials studying Multiple Myeloma
11,390 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,975 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,101 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a strong allergic reaction to pembrolizumab or any of the substances it contains.I am currently pregnant or breastfeeding.I am fully active or can carry out light work.I haven't taken any experimental antibody treatments in the last 4 weeks.I am currently taking bisphosphonates and low dose corticosteroids.I am a woman who is either postmenopausal, cannot have children, or will use birth control.I have had or currently have lung inflammation treated with steroids.I have been diagnosed with multiple myeloma according to IMWG 2014 criteria.You have a specific level of abnormal protein in your blood or urine that can be measured.I am a male and agree to use effective contraception or practice abstinence.I am not pregnant and agree to use birth control.I had BCMA CAR-T cell therapy and my cancer has worsened.Your platelet count is less than or equal to 75,000 cells per cubic millimeter at the time of screening.I have not been diagnosed or treated for another cancer within the last 2 years.My cancer has spread to my brain or spinal cord.You are allergic to acyclovir or similar antiviral medications.Your body has too few infection-fighting white blood cells at the time of screening.I am 18 years old or older, or at the legal age of consent in my area.I do not have any serious illnesses like uncontrolled diabetes or active infections.I have known heart problems.I have liver problems.I don't have any serious health or mental conditions that could stop me from completing the treatment.I completed chemotherapy more than 12 weeks ago.My kidney function is low, with a creatinine clearance of 30 mL/min or less.I had major surgery less than 4 weeks ago or am still dealing with its side effects.I have had a stem cell transplant from a donor.Your hemoglobin level is lower than 7.5 grams per deciliter when checked before the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 openings in this medical experiment for participants?
"According to the information found on clinicaltrials.gov, this medical trial is currently looking for enrollees. It was initially listed on April 11th 2022 and has had its details most recently updated on April 12th of the same year."
Answered by AI
What is the current enrollment size for this clinical trial?
"Affirmative. Clinicaltrials.gov displays data indicating that this medical test is currently recruiting patients, with the first posting occurring on April 11th 2022 and the last update being made on April 12th 2022. 30 people are needed from one research centre for this trial to be completed successfully."
Answered by AI
Has Pembrolizumab been sanctioned by the FDA?
"The safety of pembrolizumab has been assessed to be a 2 due to the lack of efficacy data available from Phase 2 trials. However, there is some information indicating its safety."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger