← Back to Search

Nivolumab for Multiple Myeloma

Phase 2
Waitlist Available
Led By Barry A Paul, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years at the time of consent
Be older than 18 years old
Must not have
Diagnosis of Waldenstrom macroglobulinemia, POEMS syndrome, or amyloidosis
History of/or active infection listed below: Active infection requiring systemic therapy, Uncontrolled Human Immunodeficiency Virus (HIV) or hepatitis B infection, Active hepatitis C infection, Known history of active TB (Bacillus Tuberculosis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment until 100 days after last dose of study treatment
Awards & highlights

Summary

"This trial aims to see if adding nivolumab to the treatment plan can help patients with relapsed refractory multiple myeloma who didn't respond well to previous treatment."

Who is the study for?
Adults with relapsed refractory multiple myeloma who've had a suboptimal response to idecabtagene vicleucel. They should be able to follow the study plan, have good performance status, and recovered from previous therapy effects. Exclusions include certain infections, other cancers within 2 years (with exceptions), recent transplants, known allergies to study drugs, active autoimmune diseases or lung issues.
What is being tested?
The trial is testing if nivolumab can improve treatment outcomes in patients with multiple myeloma after receiving idecabtagene vicleucel but not achieving an ideal response. It's about whether adding nivolumab makes the initial treatment more effective.
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation of organs like the lungs or intestines, skin reactions, hormone gland problems (like thyroiditis), liver inflammation, and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with Waldenstrom macroglobulinemia, POEMS syndrome, or amyloidosis.
Select...
I do not have an active infection needing treatment, uncontrolled HIV, hepatitis B or C, or active TB.
Select...
I have had a stem cell or organ transplant.
Select...
I am currently experiencing symptoms related to immune system overactivity or nerve damage.
Select...
I have an active autoimmune disease.
Select...
I have a history of lung scarring or inflammation not caused by infection.
Select...
I cannot take medication to prevent a specific type of pneumonia.
Select...
I have a history of myocarditis.
Select...
I have not taken steroids or immunosuppressants in the last 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to 100 days after the last dose of nivolumab
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to 100 days after the last dose of nivolumab for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Depth of Response
Secondary study objectives
Best Overall Response
Duration of Response (DoR)
Minimal Residual Disease (MRD) Negativity Rate
+2 more
Other study objectives
Number of participants who discontinued study treatment due to adverse events
Number of participants with a grade 3 or higher cytokine release syndrome event
Number of participants with a grade 3 or higher immune-related adverse event
+7 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Cushingoid
10%
Tinnitus
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Nivolumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5220

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,013,657 Total Patients Enrolled
18 Trials studying Multiple Myeloma
3,251 Patients Enrolled for Multiple Myeloma
Atrium Health Levine Cancer InstituteOTHER
24 Previous Clinical Trials
1,789 Total Patients Enrolled
2 Trials studying Multiple Myeloma
27 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbIndustry Sponsor
2,678 Previous Clinical Trials
4,125,595 Total Patients Enrolled
90 Trials studying Multiple Myeloma
22,378 Patients Enrolled for Multiple Myeloma
~33 spots leftby Nov 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top