15 Participants Needed

Pomalidomide for Waldenstrom's Macroglobulinemia

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: M.D. Anderson Cancer Center
Must be taking: Aspirin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of pomalidomide in treating patients with Waldenstrom macroglobulinemia that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Pomalidomide may stimulate the immune system in different ways and stop cancer cells from growing.

Who Is on the Research Team?

Sheeba Koshy Thomas | MD Anderson ...

Sheeba Thomas, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My Waldenstrom's macroglobulinemia has returned or didn't respond to my first treatment.
Understand and voluntarily sign an informed consent form
I can take aspirin daily or, if allergic, I can use an alternative like warfarin or heparin.
See 12 more

Exclusion Criteria

I have previously used pomalidomide.
I am known to be positive for HIV or hepatitis A, B, or C.
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive pomalidomide orally on days 1-28 or 1-21. Courses repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity.

21-28 days per course

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Pomalidomide
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (pomalidomide)Experimental Treatment1 Intervention

Pomalidomide is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Pomalyst for:
🇪🇺
Approved in European Union as Imnovid for:
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Approved in Canada as Pomalyst for:
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Approved in Japan as Imnovid for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
Unbiased ResultsWe believe in providing patients with all the options.
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