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 and Companion Study

Completed · Phase 3

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma.

Key facts

Study ID

NCT01311687

Run by

Celgene

People needed

455

Starts

2011-03-11

Expected to finish

2017-08-29

Last updated by the study team

2018-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Peter MacCallum Cancer Institute — East Melbourne, Victoria, Australia
• Frankston Hospital — Frankston, Victoria, Australia
• Princess Alexandra Hospital — Brisbane, Australia
• Royal Prince Alfred Hospital — Camperdown, Australia
• Alfred hospital — Melbourne, Australia
• Sir Charles Gairdner Hospital — Nedlands, Australia
• Calvary Mater Hospital — Waratah, Australia
• Border Medical Oncology — Wodonga, Australia
• Wollongong Hospital — Wollongong, Australia
• UZ Gent — Ghent, Belgium
• UZ Leuven — Leuven, Belgium
• CHU UCL Mont-Godinne-Dinant asbl — Yvoir, Belgium
• Tom Baker Cancer Center — Calgary, Alberta, Canada
• Cross Cancer Institute — Edmonton, Alberta, Canada
• British Columbia Cancer Agency — Vancouver, British Columbia, Canada
• James Cancer Hospital — Halifax, Nova Scotia, Canada
• Juravinski Cancer Centre — Hamilton, Ontario, Canada
• London Health Sciences Centre — London, Ontario, Canada
• University Health Network — Toronto, Ontario, Canada
• Maisonneuve Rosemont — Montreal, Quebec, Canada
• Royal Victoria Hospital McGill Department of Oncology(RVH) — Montreal, Quebec, Canada
• Sir Mortimer B. Davis - Jewish Genl — Montreal, Quebec, Canada
• Charles University General Hospital — Prague, Czechia
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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