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Proteasome Inhibitor
Pevonedistat for Multiple Myeloma
Phase 1
Waitlist Available
Led By Sagar Lonial
Research Sponsored by National Cancer Institute (NCI)
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 up to 2 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of two drugs when given together to patients with multiple myeloma that has come back or does not respond to treatment. The drugs may stop the growth of tumor cells.
Eligible Conditions
- Multiple Myeloma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Experiencing a Dose Limiting Toxicity (Dose Escalation)
Number of Participants Experiencing a Grade 3-5 Adverse Event (Dose Expansion)
Overall Response Rate (Dose Expansion)
Secondary outcome measures
Characterize the Pharmacokinetics (PK) of Pevonedistat and Ixazomib (Dose Escalation)
Other outcome measures
Biomarker analysis of NQO1 and SLC7A11
Side effects data
From 2021 Phase 2 trial • 120 Patients • NCT0261077747%
Constipation
45%
Nausea
44%
Anaemia
40%
Fatigue
35%
Pyrexia
34%
Cough
34%
Neutropenia
27%
Diarrhoea
26%
Dyspnoea
24%
Febrile neutropenia
24%
Thrombocytopenia
21%
Decreased appetite
21%
Asthenia
21%
Vomiting
19%
Arthralgia
18%
Hypokalaemia
16%
Abdominal pain
15%
Oedema peripheral
15%
Dizziness
13%
Pneumonia
13%
Back pain
13%
Headache
13%
Pruritus
11%
Platelet count decreased
11%
Bronchitis
11%
Injection site pain
11%
Insomnia
11%
Chills
10%
Epistaxis
10%
Fall
10%
Neutrophil count decreased
10%
Oral herpes
10%
Oropharyngeal pain
10%
White blood cell count decreased
8%
Erythema
8%
Aspartate aminotransferase increased
8%
Hypomagnesaemia
8%
Muscular weakness
8%
Stomatitis
8%
Urinary tract infection
8%
Weight decreased
8%
Pleural effusion
6%
Dehydration
6%
Musculoskeletal pain
6%
Hypophosphataemia
6%
Contusion
6%
Pain in extremity
6%
Productive cough
6%
Non-cardiac chest pain Pain
6%
Sepsis
6%
Alanine aminotransferase increased
6%
Hypoalbuminaemia
6%
Hypocalcaemia
6%
Hyponatraemia
6%
Malaise
6%
Nasal congestion
6%
Non-cardiac chest pain
6%
Oral candidiasis
6%
Petechiae
6%
Nasopharyngitis
3%
Cellulitis
3%
Cerebrovascular accident
3%
Gastric haemorrhage
2%
Atrial fibrillation
2%
Congestive cardiomyopathy
2%
Acute febrile neutrophilic dermatosis
2%
Embolic stroke
2%
Endocarditis
2%
Failure to thrive
2%
Gastrointestinal necrosis
2%
Hepatic lesion
2%
Lower respiratory tract infection
2%
Lung infiltration
2%
Multiple organ dysfunction syndrome
2%
Myocardial infarction
2%
Wound infection
2%
Postoperative hypotension
2%
Acute myeloid leukaemia
2%
Ankle fracture
2%
Arthritis
2%
Arthritis reactive
2%
Autoimmune haemolytic anaemia
2%
Bacteraemia
2%
Bacterial sepsis
2%
Bronchopulmonary aspergillosis
2%
Cauda equina syndrome
2%
Cholecystitis
2%
Drug hypersensitivity
2%
Gastrointestinal ulcer perforation
2%
Haematuria
2%
Haemorrhage intracranial
2%
Hypoxia
2%
Influenza
2%
Inguinal hernia
2%
Ischaemic gastritis
2%
Leukopenia
2%
Myelodysplastic syndrome
2%
Myelodysplastic syndrome transformation
2%
Post procedural hypotension
2%
Rectal haemorrhage
2%
Renal colic
2%
Respiratory tract infection
2%
Soft tissue infection
2%
Spinal compression fracture
2%
Urinary tract infection enterococcal
2%
Urinary tract obstruction
2%
Lung infection
2%
Chronic kidney disease
2%
Death
2%
Gastritis erosive
2%
Supraventricular tachycardia
2%
Thrombophlebitis superficial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azacitidine 75 mg/m^2
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ixazomib citrate, pevonedistat)Experimental Treatment2 Interventions
Patients receive ixazomib citrate PO QD on days 1, 8, and 15 of each cycle and pevonedistat IV over 60 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib Citrate
2012
Completed Phase 2
~200
Pevonedistat
2021
Completed Phase 2
~290
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,145 Total Patients Enrolled
578 Trials studying Multiple Myeloma
188,722 Patients Enrolled for Multiple Myeloma
Sagar LonialPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO
1 Previous Clinical Trials
226 Total Patients Enrolled
1 Trials studying Multiple Myeloma
226 Patients Enrolled for Multiple Myeloma
Nisha JosephPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot participate in the study if you are currently taking any experimental medications.You have severe lung artery disease that needs medication to treat.You have already tried and failed at least two different treatments.You have a serious heart rhythm problem.You have already been treated with MLN9708 (ixazomib).You had radiation therapy in the 2 weeks before the study.You must be 18 years of age or older.You have high levels of kappa or lambda light chains in your blood, and abnormal free light chain ratio.You have received treatment with at least two different types of medications, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.You are able to perform daily activities without difficulty and your overall health is good (ECOG score of 0-2).You have enough white blood cells (at least 3,000/mcL).Your body has enough white blood cells called neutrophils, with a count of at least 1,000/mcL.You have multiple myeloma and have not responded to previous treatments that included a proteasome inhibitor.You have a heart or lung condition that meets certain criteria.You had an allergic reaction to drugs similar to MLN4924 (pevonedistat) or MLN9708 (ixazomib).You were diagnosed or treated for another type of cancer within 2 years before the start of the study, or you have evidence of remaining cancer from a prior diagnosis.You are pregnant or breastfeeding.You have an abnormal amount of a specific protein in your blood that measures at least 0.5 grams per deciliter.You have a high level of a certain type of protein in your urine.This study is only for adults because the treatment has not been tested in children and the disease is rare in children.You have multiple myeloma and have either not received a type of medication called a proteasome inhibitor before, or have relapsed after taking a proteasome inhibitor in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ixazomib citrate, pevonedistat)
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.
Has the FDA sanctioned Pevonedistat for use?
"The safety of Pevonedistat has been tentatively estimated to be a 1 on the scale of 1 to 3, as this is an early-stage trial with sparse data regarding both efficacy and security."
Answered by AI
Are there any other investigations that have been conducted in relation to Pevonedistat?
"As of now, Pevonedistat is being researched in 84 active trials, 9 of which are Phase 3. Most clinical sites for this drug are located in Cleveland, Ohio; yet there exists a total of 2537 locations running Pevonedistat related studies."
Answered by AI
Are there any vacancies left in this medical experiment?
"According to the data published on clinicaltrials.gov, this experiment is not presently recruiting participants. The trial was initially launched on April 23rd 2019 and last edited July 22nd 2022; however, 891 other trials are currently seeking test subjects."
Answered by AI
How many participants are being enrolled in this experiment?
"Unfortunately, this trial is no longer recruiting participants. The study was first posted on April 23rd 2019 and the most recent edit occured on July 22nd 2022. However, there are still 807 trials related to multiple myeloma and 84 studies focused on Pevonedistat that are actively enrolling patients."
Answered by AI
How many healthcare centers are actively participating in this research trial?
"This research is recruiting at 8 distinct sites, located in Lexington, Atlanta and New Haven amongst other cities. To reduce burden on participants travelling to the trial site, we recommend selecting a location that's closest to you."
Answered by AI
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