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Corticosteroid

Pomalidomide + Melphalan + Dexamethasone for Multiple Myeloma

Phase 1
Waitlist Available
Led By Robert Orlowski, MD, PHD
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 response evaluated after a minimum of 2 cycles and a maximum of 6 cycles of 28-day treatment
Awards & highlights

Summary

The goal of this clinical research study is to find the highest tolerable dose of pomalidomide that can be given in combination with melphalan and dexamethasone that can be given to patients with AL amyloidosis. The safety of this drug combination will also be studied. Pomalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells. Melphalan is designed to damage the DNA (genetic material) of cells, which may cause cancer cells to die. Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to Multiple Myeloma (MM) patients in combination with other chemotherapy to treat cancer. Planned Phase I/II Study terminated early during Phase I portion without continuation to Phase II.

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~response evaluated after a minimum of 2 cycles and a maximum of 6 cycles of 28-day treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and response evaluated after a minimum of 2 cycles and a maximum of 6 cycles of 28-day treatment 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) of Pomalidomide with Melphalan and Dexamethasone (PMD).
Secondary study objectives
Complete Response (CR) Rate

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pomalidomide + Melphalan + DexamethasoneExperimental Treatment4 Interventions
Starting dose of Pomalidomide 1 mg/day by mouth on days 1-21. Melphalan 9 mg/m2 by mouth on days 1-4 of every 28-day cycle. Dexamethasone 40 mg/day by mouth on days 1-4. Questionnaires completed at different time points during study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan
FDA approved
Dexamethasone
FDA approved
Questionnaires
2013
Completed Phase 2
~3330
Pomalidomide
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,698 Total Patients Enrolled
78 Trials studying Multiple Myeloma
6,262 Patients Enrolled for Multiple Myeloma
CelgeneIndustry Sponsor
645 Previous Clinical Trials
130,546 Total Patients Enrolled
146 Trials studying Multiple Myeloma
41,803 Patients Enrolled for Multiple Myeloma
Robert Orlowski, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
88 Total Patients Enrolled
1 Trials studying Multiple Myeloma
88 Patients Enrolled for Multiple Myeloma
~0 spots leftby Sep 2025
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