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Checkpoint Inhibitor
Immunotherapy for Smoldering Multiple Myeloma
Phase < 1
Waitlist Available
Led By Elisabet E Manasanch
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patients with intermediate or high-risk smoldering multiple myeloma (SMM) with specific diagnostic criteria
Histologically confirmed SMM based on Mayo clinic criteria, Programa para el Tratamiento de Hemopatias Malignas (PETHEMA) criteria, or Southwestern Oncology Group (SWOG) criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 months from study entry
Awards & highlights
Study Summary
This trial is testing pembrolizumab to treat slow growing multiple myeloma. Immunotherapy with monoclonal antibodies may help the body's immune system attack the cancer.
Who is the study for?
Adults with intermediate or high-risk smoldering multiple myeloma who meet specific diagnostic criteria, have good kidney function and general health, and can give informed consent. They must not have active autoimmune diseases, other cancers, severe lung conditions, infections needing systemic therapy, or a history of certain immune disorders.Check my eligibility
What is being tested?
The trial is testing pembrolizumab's effectiveness for patients with slow-growing multiple myeloma at risk of spreading. It's an early phase study to see how well the body's immune system can fight cancer when helped by this monoclonal antibody drug.See study design
What are the potential side effects?
Pembrolizumab may cause side effects like fatigue, skin reactions, inflammation in organs such as lungs (pneumonitis), liver problems (hepatitis), hormonal gland issues (endocrinopathies), and it could potentially worsen autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Adults with a certain type of smoldering multiple myeloma that is at intermediate or high risk.
Select...
Your SMM diagnosis is confirmed by specific medical criteria from the Mayo clinic, PETHEMA, or SWOG.
Select...
You are able to perform daily activities without any problems or with only slight limitations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 30 months from study entry
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 months from study entry
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
Clinical Benefit Rate
Number of Participants That Had Progression to Multiple Myeloma
Overall Survival
Side 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 Treatment2 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 courses 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?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,761 Total Patients Enrolled
36 Trials studying Plasma Cell Myeloma
1,867 Patients Enrolled for Plasma Cell Myeloma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,133 Total Patients Enrolled
65 Trials studying Plasma Cell Myeloma
8,047 Patients Enrolled for Plasma Cell Myeloma
Elisabet E ManasanchPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
691 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a serious autoimmune disease that needed strong medication in the last 2 years.You have another cancer that is currently getting worse or is still active.You have a history of needing steroids for lung inflammation or currently have lung inflammation.You have signs of lung disease.You have an ongoing infection that needs treatment with medication throughout your body.Adults with a certain type of smoldering multiple myeloma that is at intermediate or high risk.Your SMM diagnosis is confirmed by specific medical criteria from the Mayo clinic, PETHEMA, or SWOG.You have a history of HIV or active hepatitis B or C.Your kidneys work well enough to filter out waste from your blood.You are able to perform daily activities without any problems or with only slight limitations.Your body has enough infection-fighting white blood cells.Your hemoglobin level is at least 10 grams per deciliter.You have mental health or drug problems that could affect your ability to participate in the trial.Your platelet count is at least 50 billion per liter.Your bilirubin levels are within a certain range considered normal.Your AST and ALT levels should be less than 3 times the upper limit of normal.You have a type of cancer called plasma cell leukemia.You have tuberculosis that is currently active.You have health conditions, ongoing treatments, or abnormal test results that could affect the trial outcomes.You have received treatment with a specific type of medication that targets the PD-1, PD-L1, or PD-L2 proteins before.You are allergic to pembrolizumab or any of its ingredients.There are signs that you have a specific disease called myeloma or other markers showing a possible cancer.You have received or are currently receiving systemic treatment for smoldering multiple myeloma.You have a weakened immune system or have been taking steroids for a week before the trial.
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.
What types of illnesses has Pembrolizumab been employed to address?
"Pembrolizumab is commonly used to treat a variety of malignant tumors, including those which are unresectable and exhibit microsatellite instability high. It can also be used as an adjuvant therapy following chemotherapy."
Answered by AI
Has Pembrolizumab been tested in any other clinical investigations?
"Currently, there are 962 active studies involving Pembrolizumab and 122 of them are in the advanced Phase 3 stage. Most trials for this medication occur in Houston, Texas; however, it can be accessed at 35765 different medical centres globally."
Answered by AI
Are patients currently able to enroll in this research endeavor?
"This research project is not presently recruiting patients. It was first posted on 7/20/2016 and last revised on 3/23/2022. If you are looking for other trials, 808 studies related to multiple myeloma and 962 involving Pembrolizumab have open enrolment slots currently available."
Answered by AI
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