Sunitinib in Treating Patients With Relapsed Multiple Myeloma
Condition: Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: sunitinib malate
Intervention description: Oral 37.5 mg each day of the 6-week cycle (continuous dosing).
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well sunitinib works in treating patients with relapsed
      multiple myeloma. Sunitinib may stop the growth of cancer cells by blocking some of the
      enzymes needed for cell growth and by blocking blood flow to the cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of relapsed multiple myeloma

          -  Measurable disease as defined by at least one of the following:

               -  Serum monoclonal protein ≥ 1.0 g by protein electrophoresis

               -  Urine monoclonal protein > 200 mg by 24-hour electrophoresis

               -  Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum
                  immunoglobulin kappa to lambda free light chain ratio

               -  Monoclonal bone marrow plasmacytosis ≥ 30%

          -  Not a candidate for stem cell transplantation OR have undergone prior stem cell
             collection

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Life expectancy ≥ 3 months

          -  Absolute neutrophil count ≥ 1,000/microliter (mcL)

          -  Platelets ≥ 75,000/mcL

          -  Hemoglobin ≥ 8 g/dL

          -  Total serum bilirubin normal

          -  aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper
             limit of normal

          -  Creatinine < 2.5 mg/dL

          -  Negative pregnancy test for women of childbearing potential

          -  No more than 4 prior therapies

               -  Stem cell transplantation and preceding induction therapy will be considered 1
                  therapy

          -  Prior anthracycline exposure or central thoracic radiotherapy that included the heart
             in the radiotherapy port allowed provided patient has a New York Heart Association
             (NYHA) class II or better cardiac function on baseline ECHO or multiple gated
             acquisition scan (MUGA)

          -  Concurrent bisphosphonates allowed

          -  At least 7 days since prior and no concurrent cytochrome P450 3A4 (CYP3A4) inhibitors

          -  At least 12 days since prior and no concurrent CYP3A4 inducers

        Exclusion Criteria:

          -  Pregnant or nursing women

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to sunitinib malate

          -  History of serious ventricular arrhythmia or corrected QT interval (QTc) prolongation

          -  Poorly controlled hypertension

          -  Any condition that impairs the ability to swallow and retain sunitinib malate tablets

          -  Patients with a preexisting thyroid abnormality who are unable to maintain thyroid
             function in the normal range with medication

          -  Other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the
             cervix or breast

          -  Concurrent uncontrolled illness including, but not limited to, ongoing or active
             infections or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Patients who have not recovered from adverse events of prior therapy

          -  Chemotherapy or radiotherapy ≤ 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior
             to study entry

          -  Any major surgery ≤ 4 weeks prior to study entry

          -  Nonmyelosuppressive agents ≤ 2 weeks prior to study entry

          -  Any other prior antiangiogenic agents

          -  Concurrent high-dose corticosteroids

               -  Concurrent chronic steroids (up to 20 mg/day prednisone equivalent) allowed for
                  disorders other than amyloid; NOTE: Bisphosphonates are considered to be
                  supportive care rather than therapy, and are thus allowed while on protocol
                  treatment

          -  Concurrent therapeutic doses of coumarin-derivative anticoagulants

          -  Concurrent agents with proarrhythmic potential

          -  Concurrent combination antiretroviral therapy for HIV-positive patients

          -  Any other concurrent investigational agents or anticancer therapy