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Daratumumab + Radiation/Temozolomide for Glioblastoma (PRIDE Trial)

Phase 1 & 2
Recruiting
Led By Sonikpreet Aulakh, MD
Research Sponsored by West Virginia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG Performance status ≤ 2
Subjects must have normal organ and marrow function as defined below: Leukocytes ≥ 3,000/mcL, Absolute neutrophil count ≥ 1,500/mcL, Platelet count ≥ 100,000/mcL, Total bilirubin within normal institutional limits, AST (SGOT) ≤ 3 X institutional upper limit of normal, ALT (SGPT) ≤ 3 X institutional upper limit of normal, Serum Creatinine within normal institutional limits OR glomerular filtration rate (GFR) 60 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

PRIDE Trial Summary

This trial is testing if adding Daratumumab to the standard therapy for GBM (TMZ) can help kill more cancer cells. 16 people will be enrolled in the trial, with the hope that this treatment combination will be more effective than standard therapy alone.

Who is the study for?
This trial is for adults with glioblastoma (GBM) who haven't had prior treatment for it. They must be in good general health with proper organ and marrow function, not have severe illnesses or psychiatric conditions that could affect participation, and agree to use contraception. People with certain heart diseases, uncontrolled asthma, COPD, or a history of allergic reactions to similar drugs are excluded.Check my eligibility
What is being tested?
The study tests if adding Daratumumab to the standard GBM therapy of Temozolomide (TMZ) and radiation can better kill cancer cells. It's divided into two parts: an initial phase I with up to 6 participants followed by a phase II involving 10-13 more subjects.See study design
What are the potential side effects?
Daratumumab may cause infusion reactions, fatigue, nausea, bone marrow suppression which affects blood cell counts leading to increased risk of infections or bleeding. TMZ can cause headaches, constipation/diarrhea and might harm an unborn baby; hence contraception is required.

PRIDE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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My blood tests show normal organ function and I don't have severe kidney issues.
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I had hepatitis C but am now cured or have no detectable virus while on treatment.
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I am likely to have a brain tumor (GBM) and am scheduled for surgery to confirm.

PRIDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity (DLT) rate of Daratumumab
Phase II - Median overall survival of newly diagnosed GBM patients
Secondary outcome measures
Phase I - Assess the treatment-emergent adverse events
Neoplasms
Phase I - Evaluate the Progression-Free Survival (PFS)
+4 more

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134
60%
Thrombocytopenia
50%
Peripheral sensory neuropathy
47%
Peripheral Sensory Neuropathy
36%
Upper respiratory tract infection
36%
Diarrhoea
29%
Cough
28%
Anaemia
23%
Fatigue
23%
Upper Respiratory Tract Infection
23%
Constipation
21%
Back pain
20%
Arthralgia
20%
Oedema peripheral
19%
Neutropenia
19%
Dyspnoea
18%
Insomnia
17%
Pyrexia
16%
Oedema Peripheral
15%
Nausea
14%
Lymphopenia
14%
Pain in extremity
14%
Nasopharyngitis
14%
Bronchitis
14%
Neuralgia
13%
Back Pain
13%
Dizziness
12%
Decreased appetite
12%
Vomiting
12%
Headache
12%
Hypertension
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Hypokalaemia
10%
Muscle spasms
10%
Musculoskeletal chest pain
9%
Urinary tract infection
9%
Leukopenia
9%
Bone pain
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Weight decreased
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Aspartate aminotransferase increased
6%
Nasal congestion
6%
Abdominal pain
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Throat irritation
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Acute myocardial infarction
1%
Pneumonia cytomegaloviral
1%
Pleural effusion
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Pulmonary sepsis
1%
Febrile neutropenia
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Acute coronary syndrome
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Bronchitis chronic
1%
Squamous cell carcinoma of skin
1%
Humerus fracture
1%
Respiratory failure
1%
Gastroenteritis
1%
Pathological fracture
1%
Femur fracture
1%
Ischaemic Stroke
1%
Respiratory Failure
1%
Pathological Fracture
1%
Febrile Neutropenia
1%
Cardiac Failure Congestive
1%
Bronchopneumonia
1%
Femur Fracture
1%
Humerus Fracture
1%
Acute Kidney Injury
1%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab + Bortezomib and Dexamethasone (DVd)
Bortezomib + Dexamethasone (Vd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

PRIDE Trial Design

1Treatment groups
Experimental Treatment
Group I: DaratumumabExperimental Treatment1 Intervention
Daratumumab, IV, 16 mg/KG - 1 dose prior to surgery or biopsy; Weeks 1 - 8 = 1 dose weekly; Weeks 9 - 24 = 1 dose every other week; Weeks 25 onward (determined by disease progression) = 1 dose every 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
FDA approved

Find a Location

Who is running the clinical trial?

West Virginia UniversityLead Sponsor
176 Previous Clinical Trials
60,212 Total Patients Enrolled
2 Trials studying Glioblastoma
4 Patients Enrolled for Glioblastoma
Sonikpreet Aulakh, MDPrincipal InvestigatorWVU Cancer Institute

Media Library

Daratumumab Clinical Trial Eligibility Overview. Trial Name: NCT04922723 — Phase 1 & 2
Daratumumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04922723 — Phase 1 & 2
Glioblastoma Research Study Groups: Daratumumab
Glioblastoma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT04922723 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently opportunities for patients to enroll in this experiment?

"Confirmed. According to information found on clinicaltrials.gov, this exploration is actively recruiting applicants since its launch date of October 1st 2022 and most recent edit made in October 24th 2022. The study team needs 16 subjects at one site."

Answered by AI

How many participants is the research team recruiting for this experiment?

"Yes, the latest information on clinicaltrials.gov verifies that this medical trial is currently recruiting individuals. Having been posted on October 1st 2022 and last updated on October 24th 2022, it seeks 16 participants from a single site."

Answered by AI

What is the ambition of this trial?

"The principal objective of this 12-month long study is to measure the Dose Limiting Toxicity (DLT) rate of Daratumumab. Secondary goals encompass assessing Progression-Free Survival, as well as evaluating any Treatment-emergent Adverse Events that arise from treatment commencement or worsen in severity and frequency over time."

Answered by AI

Have any other investigations been done which involve Daratumumab?

"Presently, 140 trials are taking place globally to assess Daratumumab's efficacy. Of these studies, 26 are in their terminal phase and based out of Harrison, New york; though the total number of sites conducting research on this medication is 5654."

Answered by AI

What are the primary applications of Daratumumab?

"Daratumumab is a biological response modifier, which can be employed for treating refractory multiple myeloma, relapsed or refractory multiple myeloma and cell transplants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Radiation/Temozolomide and Immunotherapy With Daratumumab to Improve Antitumor Efficacy in Glioblastoma
Sonikpreet Aulakh 2022. "Radiation/Temozolomide and Immunotherapy With Daratumumab to Improve Antitumor Efficacy in Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04922723.
~2 spots leftby Aug 2024
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