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Checkpoint Inhibitor
Immunotherapy for Smoldering Multiple Myeloma
Phase < 1
Waitlist Available
Led By Elisabet E Manasanch, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 months from study entry
Awards & highlights
No Placebo-Only Group
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.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate (ORR)
Secondary study objectives
Clinical Benefit Rate
Number of Participants That Had Progression to Multiple Myeloma
Overall Survival
Side effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 3
~3150
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,225 Total Patients Enrolled
85 Trials studying Multiple Myeloma
6,543 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,981 Total Patients Enrolled
594 Trials studying Multiple Myeloma
191,426 Patients Enrolled for Multiple Myeloma
Elisabet E Manasanch, MDPrincipal InvestigatorM.D. Anderson Cancer Center
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.
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