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Corticosteroid

Treatment (pomalidomide, dexamethasone, filgrastim-sndz) for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Led By Luhua (Michael) Wang
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 112 days (4 courses) of therapy
Awards & highlights

Summary

This phase I/II trial studies the side effects and the best dose of pomalidomide when given together with dexamethasone and filgrastim-sndz and to see how well they work in treating patients with multiple myeloma that has returned or that does not respond to treatment. Pomalidomide may stimulate or suppress the immune system in different ways and may stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Colony-stimulating factors, such as filgrastim-sndz, may increase the production of red and white blood cells and may help the immune system recover from the side effects of pomalidomide and/or dexamethasone. Giving pomalidomide together with dexamethasone and filgrastim-sndz may work better in treating patients with multiple myeloma.

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 112 days (4 courses) of therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 112 days (4 courses) of therapy for reporting.

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) (Phase I)
Secondary study objectives
Number of Participants With Best Overall Response Defined Using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pomalidomide, dexamethasone, filgrastim-sndz)Experimental Treatment4 Interventions
INDUCTION: Patients receive pomalidomide PO daily on days 1-21, dexamethasone PO on days 1, 8, 15, and 22, and filgrastim-sndz SC on days 22-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive lower-dose pomalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Filgrastim
FDA approved
Pomalidomide
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,043 Previous Clinical Trials
1,800,021 Total Patients Enrolled
77 Trials studying Multiple Myeloma
6,241 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,858 Previous Clinical Trials
41,006,713 Total Patients Enrolled
590 Trials studying Multiple Myeloma
189,336 Patients Enrolled for Multiple Myeloma
Luhua (Michael) WangPrincipal InvestigatorM.D. Anderson Cancer Center
14 Previous Clinical Trials
570 Total Patients Enrolled
1 Trials studying Multiple Myeloma
18 Patients Enrolled for Multiple Myeloma
~2 spots leftby Sep 2025
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