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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

Phase 3
18 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

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

- Subjects must have undergone prior treatment with ≥ 2 treatment lines of anti-myeloma

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to disease progression or death

Outcome Description:

Number of months between randomization and disease progression based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Mohamed Zaki, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

March 2011

Completion Date:

May 2013

Related Keywords:

  • Multiple Myeloma
  • Myeloma
  • Multiple Myeloma
  • Relapsed Multiple Myeloma
  • Relapsed and Refractory Multiple Myeloma
  • Refractory Myeloma
  • Resistant Multiple Myeloma
  • Treatment-resistant Multiple Myeloma
  • Pomalidomide
  • Lenalidomide-resistant
  • Bortezomib-resistant
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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