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
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.
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
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There are 42 Locations for this study
Duarte California, 91010, United States
Greenbrae California, 94904, United States
Los Angeles California, 90048, United States
Denver Colorado, 80218, United States
West Palm Beach Florida, 33401, United States
Marietta Georgia, 30060, United States
Peoria Illinois, 61615, United States
Indianapolis Indiana, 46202, United States
Iowa City Iowa, 52242, United States
Baltimore Maryland, 21215, United States
Hyannis Massachusetts, 02601, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68198, United States
Hackensack New Jersey, 07601, United States
New York New York, 10016, United States
New York New York, 10029, United States
Philadelphia Pennsylvania, 19107, United States
Sellersville Pennsylvania, 18960, United States
Greenville South Carolina, 29615, United States
Sioux Falls South Dakota, 57105, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84106, United States
Morgantown West Virginia, 26506, United States
Milwaukee Wisconsin, 53226, United States
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z1M, Canada
Victoria British Columbia, V8R6V, Canada
Winnipeg Manitoba, R3E 0, Canada
St. John's Newfoundland and Labrador, A1B3V, Canada
Halifax Nova Scotia, B3H 1, Canada
Hamilton Ontario, L8V 5, Canada
London Ontario, N6A 4, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 2, Canada
Windsor Ontario, N8W1L, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H3A 1, Canada
Montreal Quebec, H3T 1, Canada
Quebec City Quebec, G1R 2, Canada
Saskatoon Saskatchewan, S7N 4, Canada
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