Pomalidomide for Waldenstrom's Macroglobulinemia

Recruiting in Palo Alto (17 mi)

Overseen by Sheeba Thomas, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

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.

Eligibility Criteria

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.

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

Participant Groups

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.

Group I: Treatment (pomalidomide) Experimental Treatment 1 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.

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

🇺🇸 Approved in United States as Pomalyst for:

• Multiple myeloma
• Kaposi's sarcoma

🇪🇺 Approved in European Union as Imnovid for:

• Multiple myeloma
• Kaposi's sarcoma

🇨🇦 Approved in Canada as Pomalyst for:

• Multiple myeloma
• Kaposi's sarcoma

🇯🇵 Approved in Japan as Imnovid for:

• Multiple myeloma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

References