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Immunomodulatory Agent
Pomalidomide for Waldenstrom's Macroglobulinemia
Phase 1
Waitlist Available
Led By Sheeba K Thomas
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Waldenstrom's macroglobulinemia that has relapsed and/or is refractory to at least one prior line of therapy
All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study
Must not have
Any prior use of pomalidomide
Known positive for human immunodeficiency virus (HIV) or acute hepatitis A or acute or chronic active hepatitis B or C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the side effects and best dose of pomalidomide for treating patients with Waldenstrom macroglobulinemia who have relapsed or are refractory.
Who is the study for?
This trial is for adults with Waldenstrom macroglobulinemia that has come back or isn't responding to treatment. They must be fairly active (ECOG <=2), have normal liver function, and not have had cancer treatments in the last 4 weeks. People can't join if they're allergic to similar drugs, pregnant, breastfeeding, HIV positive, or have certain other health issues.
What is being tested?
The trial is testing Pomalidomide's safety and the best dose for treating relapsed/refractory Waldenstrom macroglobulinemia. It aims to see how well it stimulates the immune system to stop cancer growth.
What are the potential side effects?
Pomalidomide may cause side effects like blood clots, fatigue, constipation, neuropathy (nerve pain), low blood counts leading to increased infection risk or bleeding problems. Specific side effects will vary by individual.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Waldenstrom's macroglobulinemia has returned or didn't respond to my first treatment.
Select...
I stopped all cancer treatments including radiation, hormonal therapy, and surgery at least 4 weeks ago.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have been cancer-free for 5 years, except for certain skin cancers or early-stage cervical/breast cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have previously used pomalidomide.
Select...
I am known to be positive for HIV or hepatitis A, B, or C.
Select...
I am not using any other cancer treatments.
Select...
I developed a peeling rash from thalidomide or similar medications.
Select...
I do not have severe numbness or pain in my hands or feet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose (MTD) of pomalidomide
Side effects data
From 2015 Phase 2 trial • 36 Patients • NCT0201111372%
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%
FATIGUE
11%
EPISTAXIS
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%
CANCER PAIN
6%
DECUBITUS ULCER
6%
PERIPHERAL SENSORY NEUROPATHY
6%
INCREASED APPETITE
6%
CYSTITIS
6%
DIABETES MELLITUS
6%
GASTROENTERITIS
6%
RESTLESSNESS
6%
HEADACHE
6%
NEUROPATHY PERIPHERAL
6%
WEIGHT INCREASED
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%
PNEUMONIA PNEUMOCOCCAL
3%
MULTI-ORGAN FAILURE
3%
PNEUMOCYSTIS JIROVECII PNEUMONIA
3%
SEPSIS
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pomalidomide)Experimental Treatment1 Intervention
Patients receive pomalidomide PO on days 1-28 or 1-21. Courses repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.
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?
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,986 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,230 Total Patients Enrolled
Sheeba K ThomasPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My Waldenstrom's macroglobulinemia has returned or didn't respond to my first treatment.I can take aspirin daily or, if allergic, I can use an alternative like warfarin or heparin.Your platelet count is at least 20,000 per microliter.I have previously used pomalidomide.I stopped all cancer treatments including radiation, hormonal therapy, and surgery at least 4 weeks ago.You have enough white blood cells called neutrophils in your body.I am committed to following strict birth control measures or abstinence as required.I am known to be positive for HIV or hepatitis A, B, or C.I am not pregnant or breastfeeding, or I agree not to breastfeed while on pomalidomide and for 28 days after.Your kidneys work well enough to clear at least 45 milliliters of creatinine from your body every minute.Your bilirubin levels in your blood are not too high.I am not using any other cancer treatments.I haven't used any experimental drugs or therapies in the last 28 days.Your AST and ALT levels in your blood should not be higher than two times the normal limit.Your blood creatinine level is less than or equal to 2.0 mg/dL.My neutrophil or platelet counts are low, but not due to Waldenström's macroglobulinemia.I developed a peeling rash from thalidomide or similar medications.I do not have severe numbness or pain in my hands or feet.You are allergic to thalidomide or lenalidomide.I can take care of myself but might not be able to do heavy physical work.I have been cancer-free for 5 years, except for certain skin cancers or early-stage cervical/breast cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pomalidomide)
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.
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