Multiple Myeloma Clinical Trial

Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma

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

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Must have documented diagnosis of relapsed or relapsed/refractory multiple myeloma and have measurable disease (serum or urine M-protein)
Age ≥ 18 years
Must have had at least ≥ 2 prior anti-myeloma therapies
Must have received at least 2 consecutive cycles of both lenalidomide and bortezomib, either alone or in combination
Must have failed treatment with the last lenalidomide-containing regimen and the last bortezomib-containing regimen
Must have documented disease progression during or after the last antimyeloma regimen
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.
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:

Peripheral Neuropathy ≥ Grade 2
Non-secretory multiple myeloma
Previous therapy with pomalidomide
Use of any investigational agents within 28 days or 5 half lives (whichever is longer) of initiating study treatment
Subjects with conditions requiring chronic steroid or immunosuppressive treatment.
Hypersensitivity to thalidomide, lenalidomide or dexamethasone
Known Human Immunodeficiency Virus positive, active or chronic Hepatitis A, B or C
Pregnant or breastfeeding females
Unacceptable hematological or biochemical laboratory abnormalities

Study is for people with:

Multiple Myeloma

Study ID:

NCT01632826

Recruitment Status:

Approved for marketing

Sponsor:

Celgene

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There are 42 Locations for this study

See Locations Near You

Celgene Study Site
Duarte California, 91010, United States
Celgene Study Site
Greenbrae California, 94904, United States
Celgene Study Site
Los Angeles California, 90048, United States
Celgene Study Site
Denver Colorado, 80218, United States
Celgene Study Site
West Palm Beach Florida, 33401, United States
Celgene Study Site
Marietta Georgia, 30060, United States
Celgene Study Site
Peoria Illinois, 61615, United States
Celgene Study Site
Indianapolis Indiana, 46202, United States
Celgene Study Site
Iowa City Iowa, 52242, United States
Celgene Study Site
Baltimore Maryland, 21215, United States
Celgene Study Site
Hyannis Massachusetts, 02601, United States
Celgene Study Site
Saint Louis Missouri, 63110, United States
Celgene Study Site
Omaha Nebraska, 68198, United States
Celgene Study Site
Hackensack New Jersey, 07601, United States
Celgene Study Site
New York New York, 10016, United States
Celgene Study Site
New York New York, 10029, United States
Celgene Study Site
Philadelphia Pennsylvania, 19107, United States
Celgene Study Site
Sellersville Pennsylvania, 18960, United States
Celgene Study Site
Greenville South Carolina, 29615, United States
Celgene Study Site
Sioux Falls South Dakota, 57105, United States
Celgene Study Site
Dallas Texas, 75390, United States
Celgene Study Site
Houston Texas, 77030, United States
Celgene Study Site
Salt Lake City Utah, 84106, United States
Celgene Study Site
Morgantown West Virginia, 26506, United States
Celgene Study Site
Milwaukee Wisconsin, 53226, United States
Celgene Study Site
Calgary Alberta, T2N 4, Canada
Celgene Study Site
Edmonton Alberta, T6G 1, Canada
Celgene Study Site
Vancouver British Columbia, V5Z1M, Canada
Celgene Study Site
Victoria British Columbia, V8R6V, Canada
Celgene Study Site
Winnipeg Manitoba, R3E 0, Canada
Celgene Study Site
St. John's Newfoundland and Labrador, A1B3V, Canada
Celgene Study Site
Halifax Nova Scotia, B3H 1, Canada
Celgene Study Site
Hamilton Ontario, L8V 5, Canada
Celgene Study Site
London Ontario, N6A 4, Canada
Celgene Study Site
Ottawa Ontario, K1H 8, Canada
Celgene Study Site
Toronto Ontario, M5G 2, Canada
Celgene Study Site
Windsor Ontario, N8W1L, Canada
Celgene Study Site
Montreal Quebec, H1T 2, Canada
Celgene Study Site
Montreal Quebec, H3A 1, Canada
Celgene Study Site
Montreal Quebec, H3T 1, Canada
Celgene Study Site
Quebec City Quebec, G1R 2, Canada
Celgene Study Site
Saskatoon Saskatchewan, S7N 4, Canada

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Study ID:

NCT01632826

Recruitment Status:

Approved for marketing

Sponsor:


Celgene

How clear is this clinincal trial information?

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