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Single Arm 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
1. Written informed consent and HIPAA authorization for release of personal health information signed by the participant or his/her legally authorized representative
2. Age ≥ 18 years at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment until 100 days after last dose of study treatment
Awards & highlights

Summary

This study is designed to evaluate if treatment with adjuvant nivolumab improves depth of response in patients with relapsed refractory multiple myeloma (RRMM) who achieve a less-than-ideal response to idecaptagene vicleucel.

Eligible Conditions
  • Multiple Myeloma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Chest pain
10%
Muscular weakness
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Abdominal pain upper
9%
Peripheral sensory neuropathy
8%
Nasopharyngitis
8%
Lacrimation increased
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Hyperkalaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Pain
5%
Malaise
5%
Dry mouth
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Adrenal insufficiency
2%
Embolism
2%
Atrial fibrillation
2%
Cardiac failure
2%
General physical health deterioration
2%
Sepsis
1%
Pericardial effusion
1%
Small intestinal obstruction
1%
Cancer pain
1%
Confusional state
1%
Gastrointestinal haemorrhage
1%
Bronchial obstruction
1%
Ileus
1%
Small intestinal haemorrhage
1%
Performance status decreased
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Lung cancer metastatic
1%
Syncope
1%
Circulatory collapse
1%
Superior vena cava syndrome
1%
Pancytopenia
1%
Atrial flutter
1%
Colitis
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Pneumothorax
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

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
~4740

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,258 Previous Clinical Trials
1,011,898 Total Patients Enrolled
18 Trials studying Multiple Myeloma
3,251 Patients Enrolled for Multiple Myeloma
Atrium Health Levine Cancer InstituteOTHER
21 Previous Clinical Trials
1,624 Total Patients Enrolled
2 Trials studying Multiple Myeloma
27 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbIndustry Sponsor
2,666 Previous Clinical Trials
4,133,077 Total Patients Enrolled
89 Trials studying Multiple Myeloma
30,533 Patients Enrolled for Multiple Myeloma
~33 spots leftby Nov 2027
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