AZD6244 (Selumetinib) in Treating Patients With Multiple Myeloma

Completed · Phase 2

Conditions studied: Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma

In brief

This phase II trial studies how well selumetinib works in treating patients with multiple myeloma, a type of cancer in which a specific protein is over active. Selumetinib may stop the growth of cancer cells by blocking this protein.

Key facts

Study ID: NCT01085214
Run by: National Cancer Institute (NCI)
People needed: 37
Starts: 2010-03-01
Expected to finish: 2012-03-01
Last updated by the study team: 2015-08-19

Who can join

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

You may qualify if…

Confirmed diagnosis of multiple myeloma with relapsed or refractory disease following at least two prior therapies
Measurable disease defined as:
Serum monoclonal protein >= 1 gm/dL or
Urine monoclonal protein of >= 200 mg/24 hours, or
Measurable free light chains by free light chain assay of >= 10 mg/dL with abnormal kappa to lambda free light chain ratio, or
Measurable bone disease, defined as >= 1 unidimensionally measurable lesion (longest diameter to be recorded) >= 20 mm with conventional techniques or >= 10 mm with spiral computed tomography (CT) scan (for patients with lytic bone disease)
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Absolute neutrophil count: >= 1,000/μL (independent of blood cell growth factors)
Platelets: >= 75,000/μL (independent of blood cell growth factors or transfusion)
Total bilirubin: =< 1.5 x upper normal limit; however, patients with documented Gilbert's syndrome are eligible
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]): < 2.5 x upper limit of normal (ULN)
Creatinine: < 3.0 x ULN
Known human immunodeficiency virus (HIV) infected patients meeting the following characteristics are eligible:
Cluster of differentiation (CD)4 cell count >= 500/mm\^3
Meeting either of the following:
Willing to suspend antiretroviral therapy for duration of protocol therapy or
On stable regimen of combination antiretroviral therapy that does not include either zidovudine or stavudine for at least 12 weeks and without evidence of toxicity
No HIV-associated condition that defines acquired immunodeficiency syndrome (AIDS)
Prior allogeneic stem cell transplant is allowed provided that all of the following conditions are met:
>= 6 months have elapsed since allogeneic transplant
No graft vs. host disease (GVHD) is present
Not currently on immunosuppressive therapy
Women of child-bearing potential must agree to use a medically accepted form of contraception prior to, during, and for four weeks following study treatment; men must agree to use a medically accepted form of contraception prior to, during, and for sixteen weeks following study treatment
Able and willing to provide a written informed consent
Prior palliative and/or localized radiation therapy is permitted, provided at least 14 days have passed from date of last radiation therapy

You may not qualify if…

Any concurrent condition or planned treatment that would compromise study objectives or represent an unacceptable patient risk, including but not limited to:
Planned concurrent treatment for multiple myeloma other than bisphosphonates; ongoing corticosteroids for indications other than multiple myeloma allowed as long as the dose does not exceed 60 mg of prednisone per day or equivalent
Persisting effects of any previous or ongoing treatment that might compromise delivery of study treatment or assessment of adverse events
Planned concurrent treatment with any other investigational agents
Cytotoxic chemotherapy less than 2 weeks, or biologic therapy less than 2 weeks, or corticosteroids less than 2 weeks prior to registration
No other malignancy unless the patient has been disease-free for >= 1 year
Known multiple myeloma of central nervous system or leptomeninges
History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD6244
Previous mitogen activated protein kinase (MEK) inhibitor use
Uncontrolled hypertension, i.e., persistent blood pressure (BP) of >= 160/95
Significant cardiovascular disease (New York Heart Association class II, III or IV cardiac disease), hypertrophic cardiomegaly or restrictive cardiomyopathy, myocardial infarction within the past 6 months, unstable angina, unstable arrhythmia unstable or a need for anti-arrhythmic therapy (use of medication for atrial fibrillation is allowed, if stable for at least 3 months)
Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g. inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant or nursing
Left ventricular ejection fraction (LVEF) =< 45% by echocardiogram (ECHO) or multigated acquisition scan (MUGA) scan
Any requirement for supplemental oxygen

Where it is running

Moffitt Cancer Center — Tampa, Florida, United States
Emory University/Winship Cancer Institute — Atlanta, Georgia, United States
University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
Mark O Hatfield-Warren Grant Magnuson Clinical Center — Bethesda, Maryland, United States
National Institutes of Health — Bethesda, Maryland, United States
Billings Clinic Cancer Center — Billings, Montana, United States
University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
Virginia Commonwealth University/Massey Cancer Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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