A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma
Inclusion Criteria:
- Must be ≥ 18 years of age
- Subjects must have documented diagnosis of multiple myeloma and have measurable
disease
- Subjects must have undergone prior treatment with ≥ 2 treatment lines of anti-myeloma
therapy
- Subjects must have either refractory or relapsed and refractory disease defined as
documented disease progression during or within 60 days of completing their last
myeloma therapy
- All subjects must have received at least 2 consecutive cycles of prior treatment that
included lenalidomide and bortezomib
- All subjects must have failed treatment with both lenalidomide and bortezomib in one
of the following ways: 1) Documented progressive disease on or within 60 days of
completing treatment with lenalidomide and/or bortezomib, or 2) In case of prior
response [≥ partial response (PR)] to lenalidomide or bortezomib, subjects must have
relapsed within 6 months after stopping treatment with lenalidomide and/or
bortezomib-containing regimens, or 3) Subjects who have not had a ≥ minimal response
(MR) and have developed intolerance/toxicity after a minimum of two cycles of
lenalidomide- and/or bortezomib-containing regimen
- Patients must have received adequate prior alkylator therapy
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Females of childbearing potential (FCBP) must not become pregnant for 28 days prior
to initiation of study drug, during the study, and for 28 days after discontinuation
- Females must agree to abstain from breastfeeding during study participation and 28
days after study drug discontinuation
- Males must agree to use a latex condom during any sexual during the study and for 28
days following discontinuation from this study
- Males must also agree to refrain from donating semen or sperm while on pomalidomide
and for 28 days after discontinuation from this study
Exclusion Criteria:
- Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) < 1,000/μL
- Platelet count < 75,000/ μL for subjects in whom < 50% of bone marrow nucleated
cells are plasma cells
- Creatinine Clearance < 45 mL/min
- Corrected serum calcium > 14 mg/dL
- Hemoglobin ≤ 8 g/dL
- Serum glutamic oxaloacetic transaminase (SGOT)/ aspartate aminotransferase (AST)
or Transaminase, serum glutamic pyruvic (SGPT)/ alanine aminotransferase (ALT) >
3.0 x upper limit of normal (ULN)
- Serum total bilirubin > 2.0 mg/dL
- Previous therapy with Pomalidomide
- Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
- Resistance to high-dose dexamethasone used in the last line of therapy
- Peripheral neuropathy ≥ Grade 2
- Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem
cell transplant
- Subjects who are planning for or who are eligible for stem cell transplant
- Subjects with any one of the following: 1) Congestive heart failure, 2) Myocardial
infarction within 12 months prior to starting study treatment, 3) Unstable or poorly
controlled angina pectoris, including Prinzmetal variant angina pectoris
- Subjects who received any of the following within the last 14 days of initiation of
study treatment: 1) Plasmapheresis, 2) Major surgery, 3) Radiation therapy, 4) Use of
any anti-myeloma drug therapy
- Use of any investigational agents within 28 days or 5 half-lives (whichever is
longer) of treatment
- Subjects with conditions requiring chronic steroid or immunosuppressive treatment
- Any condition including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study
- Incidence of gastrointestinal disease that may significantly alter the absorption of
pomalidomide
- Subjects unable or unwilling to undergo antithrombotic prophylactic treatment
- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subjects from signing the informed consent form
- Pregnant or breastfeeding females
- Known Human Immunodeficiency Virus (HIV) positivity or active infectious hepatitis A,
B or C