MedTrace Logo

Pomalidomide With Melphalan and Dexamethasone for Untreated Systemic AL Amyloidosis

NCT01807286 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2016-05-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pomalidomide

Phase I: Starting dose of Pomalidomide 1 mg/day by mouth on days 1-21 of a 28 day cycle. Phase II: Starting dose of Pomalidomide maximum tolerated dose from Phase I.

DRUG

Melphalan

Phase I and II: 9 mg/m2 by mouth on days 1-4 of a 28-day cycle.

DRUG

Dexamethasone

Phase I and II: 40 mg/day by mouth on days 1-4 of a 28 day cycle.

BEHAVIORAL

Questionnaires

Questionnaires about the feeling in hands and quality of life completed at different time points during the study.

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Robert Orlowski, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01807286 on ClinicalTrials.gov