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 a likelihood of benefit from the pomalidomide treatment while the medication is not commercially 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
Eligibility Age
Minimum: 18 Years
United States

Celgene Study Site
Duarte, California, 91010

Celgene Study Site
Greenbrae, California, 94904

Celgene Study Site
Los Angeles, California, 90048

Celgene Study Site
Denver, Colorado, 80218

Celgene Study Site
West Palm Beach, Florida, 33401

Celgene Study Site
Marietta, Georgia, 30060

Celgene Study Site
Peoria, Illinois, 61615

Celgene Study Site
Indianapolis, Indiana, 46202

Celgene Study Site
Iowa City, Iowa, 52242

Celgene Study Site
Baltimore, Maryland, 21215

Celgene Study Site
Hyannis, Massachusetts, 02601

Celgene Study Site
Saint Louis, Missouri, 63110

Celgene Study Site
Omaha, Nebraska, 68198

Celgene Study Site
Hackensack, New Jersey, 07601

Celgene Study Site
New York, New York, 10016

Celgene Study Site
New York, New York, 10029

Celgene Study Site
Philadelphia, Pennsylvania, 19107

Celgene Study Site
Sellersville, Pennsylvania, 18960

Celgene Study Site
Greenville, South Carolina, 29615

Celgene Study Site
Sioux Falls, South Dakota, 57105

Celgene Study Site
Dallas, Texas, 75390

Celgene Study Site
Houston, Texas, 77030

Celgene Study Site
Salt Lake City, Utah, 84106

Celgene Study Site
Morgantown, West Virginia, 26506

Celgene Study Site
Milwaukee, Wisconsin, 53226

Lars Sternas, MD, PhD
Study Director
Celgene Corporation

NCT Number
refractory multiple myeloma
MeSH Terms
Multiple Myeloma
Neoplasms, Plasma Cell