Official Title
A Multicenter, Single-Arm, Open-Label Treatment Use Protocol for Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma
Brief Summary

To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with alikelihood of benefit from the pomalidomide treatment while the medication is notcommercially available

Detailed Description

Several clinical studies indicate that pomalidomide has activity in relapsed and
refractory multiple myeloma with response rates ranging between 30% and 60% at
pomalidomide doses at 2 mg/day and/or 4 mg/day.

Approved for marketing
Multiple Myeloma

Drug: Pomalidomide

4 mg daily for 21 days in a 28 day cycle until disease progression or other reasons for
treatment discontinuation

Eligibility Criteria

Inclusion Criteria:

1. Must have documented diagnosis of relapsed or relapsed/refractory multiple myeloma
and have measurable disease (serum or urine M-protein)

2. Age ≥ 18 years

3. Must have had at least ≥ 2 prior anti-myeloma therapies

4. Must have received at least 2 consecutive cycles of both lenalidomide and
bortezomib, either alone or in combination

5. Must have failed treatment with the last lenalidomide-containing regimen and the
last bortezomib-containing regimen

6. Must have documented disease progression during or after the last antimyeloma
regimen

7. Females of childbearing potential (FCBP) must agree to utilize two reliable forms of
contraception simultaneously or practice complete abstinence from heterosexual
contact for at least 28 days before starting drug, while participating in the study
and for at least 28 days after study treatment discontinuation.

8. Males must agree to use a latex condom during sexual contact with FCBP while
participating in the study and for 28 days following discontinuation from study
treatment.

Exclusion Criteria:

1. Peripheral Neuropathy ≥ Grade 2

2. Non-secretory multiple myeloma

3. Previous therapy with pomalidomide

4. Use of any investigational agents within 28 days or 5 half lives (whichever is
longer) of initiating study treatment

5. Subjects with conditions requiring chronic steroid or immunosuppressive treatment.

6. Hypersensitivity to thalidomide, lenalidomide or dexamethasone

7. Known Human Immunodeficiency Virus positive, active or chronic Hepatitis A, B or C

8. Pregnant or breastfeeding females

9. Unacceptable hematological or biochemical laboratory abnormalities

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Canada
United States
Locations

Celgene Study Site
Duarte, California, United States

Celgene Study Site
Greenbrae, California, United States

Celgene Study Site
Los Angeles, California, United States

Celgene Study Site
Denver, Colorado, United States

Celgene Study Site
West Palm Beach, Florida, United States

Celgene Study Site
Marietta, Georgia, United States

Celgene Study Site
Peoria, Illinois, United States

Celgene Study Site
Indianapolis, Indiana, United States

Celgene Study Site
Iowa City, Iowa, United States

Celgene Study Site
Baltimore, Maryland, United States

Celgene Study Site
Hyannis, Massachusetts, United States

Celgene Study Site
Saint Louis, Missouri, United States

Celgene Study Site
Omaha, Nebraska, United States

Celgene Study Site
Hackensack, New Jersey, United States

Celgene Study Site
New York, New York, United States

Celgene Study Site
New York, New York, United States

Celgene Study Site
Philadelphia, Pennsylvania, United States

Celgene Study Site
Sellersville, Pennsylvania, United States

Celgene Study Site
Greenville, South Carolina, United States

Celgene Study Site
Sioux Falls, South Dakota, United States

Celgene Study Site
Dallas, Texas, United States

Celgene Study Site
Houston, Texas, United States

Celgene Study Site
Salt Lake City, Utah, United States

Celgene Study Site
Morgantown, West Virginia, United States

Celgene Study Site
Milwaukee, Wisconsin, United States

Celgene Study Site
Calgary, Alberta, Canada

Celgene Study Site
Edmonton, Alberta, Canada

Celgene Study Site
Vancouver, British Columbia, Canada

Celgene Study Site
Victoria, British Columbia, Canada

Celgene Study Site
Winnipeg, Manitoba, Canada

Celgene Study Site
St. John's, Newfoundland and Labrador, Canada

Celgene Study Site
Halifax, Nova Scotia, Canada

Celgene Study Site
Hamilton, Ontario, Canada

Celgene Study Site
London, Ontario, Canada

Celgene Study Site
Ottawa, Ontario, Canada

Celgene Study Site
Toronto, Ontario, Canada

Celgene Study Site
Windsor, Ontario, Canada

Celgene Study Site
Montreal, Quebec, Canada

Celgene Study Site
Montreal, Quebec, Canada

Celgene Study Site
Montreal, Quebec, Canada

Celgene Study Site
Quebec City, Quebec, Canada

Celgene Study Site
Saskatoon, Saskatchewan, Canada

Lars Sternas, MD, PhD, Study Director
Celgene Corporation

NCT Number
Keywords
relapsed
refractory multiple myeloma
pomalidomide
MeSH Terms
Multiple Myeloma
Neoplasms, Plasma Cell
Pomalidomide