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Immunomodulatory Agent

Pomalidomide for Medulloblastoma

Phase 2
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first dose of pomalidomide to the data cut-off date of 15 march 2019; median overall time on follow-up was 4.86 months (3.78, 5.65, 4.04, and 8.38 months in each group respectively).
Awards & highlights

Study Summary

This trial will study whether the drug pomalidomide is effective, safe, and tolerated in children and young adults with certain types of brain tumors that have come back or are progressing.

Eligible Conditions
  • Medulloblastoma
  • Brain Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first dose of pomalidomide to the data cut-off date of 15 march 2019; median overall time on follow-up was 4.86 months (3.78, 5.65, 4.04, and 8.38 months in each group respectively).
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose of pomalidomide to the data cut-off date of 15 march 2019; median overall time on follow-up was 4.86 months (3.78, 5.65, 4.04, and 8.38 months in each group respectively). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With an Objective Response or Long-term Stable Disease
Secondary outcome measures
Kalan-Meier Estimate of Overall Survival
Kaplan-Meier Estimate of Duration of Response
Kaplan-Meier Estimate of Progression-Free Survival (PFS)
+3 more

Side effects data

From 2015 Phase 2 trial • 36 Patients • NCT02011113
72%
NEUTROPENIA
47%
ANAEMIA
44%
THROMBOCYTOPENIA
25%
NASOPHARYNGITIS
25%
PYREXIA
25%
CONSTIPATION
22%
LYMPHOPENIA
19%
DIARRHOEA
19%
OEDEMA PERIPHERAL
19%
NAUSEA
19%
RASH
17%
LEUKOPENIA
17%
INSOMNIA
17%
MALAISE
14%
PNEUMONIA
14%
DYSGEUSIA
11%
EPISTAXIS
11%
FATIGUE
11%
DECREASED APPETITE
11%
HYPERURICAEMIA
11%
HYPOALBUMINAEMIA
11%
UPPER RESPIRATORY TRACT INFECTION
11%
HYPOKALAEMIA
8%
RASH MACULO-PAPULAR
8%
Pharyngitis
8%
HYPERGLYCAEMIA
8%
HYPOPHOSPHATAEMIA
8%
HYPOXIA
8%
ANXIETY
8%
MYALGIA
8%
HEPATIC FUNCTION ABNORMAL
8%
HERPES ZOSTER
6%
HEADACHE
6%
CANCER PAIN
6%
CYSTITIS
6%
WEIGHT INCREASED
6%
DECUBITUS ULCER
6%
GASTROENTERITIS
6%
NEUROPATHY PERIPHERAL
6%
DIABETES MELLITUS
6%
PERIPHERAL SENSORY NEUROPATHY
6%
INCREASED APPETITE
6%
RESTLESSNESS
6%
HYPOTENSION
6%
HYPOGAMMAGLOBULINAEMIA
6%
ABDOMINAL PAIN UPPER
6%
HAEMORRHOIDS
6%
ASTHMA
6%
VOMITING
6%
BRONCHITIS
6%
HYPERCALCAEMIA
6%
HYPOCALCAEMIA
6%
HYPONATRAEMIA
6%
HYPERSOMNIA
6%
DYSPHONIA
6%
PLEURAL EFFUSION
6%
HICCUPS
6%
ALANINE AMINOTRANSFERASE INCREASED
6%
ASPARTATE AMINOTRANSFERASE INCREASED
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
MUSCLE SPASMS
6%
WEIGHT DECREASED
6%
TREMOR
6%
HYPOTHYROIDISM
6%
SOMNOLENCE
6%
PROCTALGIA
6%
DYSPNOEA
3%
SEPSIS
3%
PNEUMOCYSTIS JIROVECII PNEUMONIA
3%
PNEUMONIA PNEUMOCOCCAL
3%
MULTI-ORGAN FAILURE
3%
INTERSTITIAL LUNG DISEASE
3%
C-REACTIVE PROTEIN INCREASED
3%
CARDIAC FAILURE
3%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
3%
URINARY RETENTION
3%
MENINGITIS
3%
SPINAL COMPRESSION FRACTURE
3%
BLOOD FIBRINOGEN DECREASED
3%
BACK PAIN
3%
SHOCK HAEMORRHAGIC
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pomalidomide Plus Dexamethasone

Trial Design

1Treatment groups
Experimental Treatment
Group I: PomalidomideExperimental Treatment1 Intervention
Pomalidomide will administered at a starting dose of 2.6 m2/day. Pomalidomide will be provided as either a capsule (0.5 mg, 1 mg, 2 mg, 3 mg or 4 mg) or as an oral suspension (2 mg/mL).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
2011
Completed Phase 2
~1020

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,918 Total Patients Enrolled
Bouchra Benettaib, MDStudy DirectorCelgene Corporation
3 Previous Clinical Trials
52 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,506 Previous Clinical Trials
3,369,477 Total Patients Enrolled
1 Trials studying Medulloblastoma
15 Patients Enrolled for Medulloblastoma

Media Library

Pomalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03257631 — Phase 2
Medulloblastoma Research Study Groups: Pomalidomide
Medulloblastoma Clinical Trial 2023: Pomalidomide Highlights & Side Effects. Trial Name: NCT03257631 — Phase 2
Pomalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03257631 — Phase 2

Frequently Asked Questions

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

In how many different medical clinics is this medical study being run today?

"Yes, there are 7 enrolling patients for this study. Some of the locations where you can take part in this trial include Stanford University Cancer Center in Stanford, University of Florida in Gainesville, and National Cancer Institute in Chicago."

Answered by AI

Are there any positions left in this clinical trial for new participants?

"This particular trial is not accepting patients at this time, however there are 556 other trials for medulloblastoma and 88 studies involving Pomalidomide that are."

Answered by AI

Would I be able to join this clinical study?

"This study is looking for 53 participants aged 1-21 who currently have medulloblastoma. In addition to meeting the age requirements, patients must also meet the following criteria: -Subject (when applicable, parental/legal representative) must understand and voluntarily sign an ICF/IAF prior to any study-related assessments/procedures being conducted.-Subject has received at least one prior standard therapy (or generally accepted upfront therapy if no standard exists) and have no known curative therapy.-Subject has Karnofsky (age ≥ 16 years) or Lansky (age < 16 years)"

Answered by AI

How many people are enrolled in this trial?

"Right now, this particular clinical trial is not looking for new patients to enroll. The first posting was on August 22nd, 2017 and the most recent update occurred on September 28th, 2022. There are 556 other trials related to medulloblastoma that are actively recruiting and 88 for Pomalidomide if you're interested in alternative studies."

Answered by AI

Is this research only seeking out people who are 45 and older?

"The age bracket for this study is 1-21 years old."

Answered by AI

Is there a significant body of research on Pomalidomide?

"At this time, there are a total of 88 clinical trials involving Pomalidomide with 10 being in Phase 3. The largest concentration of these studies is based in Houston, Texas; however, there are 2773 locations running trials for Pomalidomide globally."

Answered by AI

Is Pomalidomide a danger to patients?

"While Pomalidomide has shown some efficacy in clinical trials, there is currently not enough data to support its use. Consequently, it received a score of 2."

Answered by AI
~7 spots leftby Apr 2025