Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma (PEXIUS)
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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
Condition or disease
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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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
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.
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