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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

Approved for 60 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ response evaluated after a minimum of 2 cycles and a maximum of 6 cycles of 28-day treatment

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

Awards & Highlights

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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: 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

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