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Sunitinib in Treating Patients With Relapsed Multiple Myeloma
This study is ongoing, but not recruiting participants.
First Received: August 8, 2007   Last Updated: April 18, 2009   History of Changes
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00514137
  Purpose

RATIONALE: 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.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with relapsed multiple myeloma.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: sunitinib malate
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Sunitinib malate Sunitinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Confirmed response (complete response, very good partial response, or partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: September 2007
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To assess the response rate in patients with relapsed multiple myeloma treated with sunitinib malate.

Secondary

  • To assess the toxicity of sunitinib malate in patients with relapsed multiple myeloma.
  • To assess time to progression after initial response to sunitinib malate.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3-6 months for up to 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

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% (evaluable disease)
  • Not a candidate for stem cell transplantation OR have undergone prior stem cell collection

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Absolute neutrophil count ≥ 1,000/mcL
  • Platelets ≥ 75,000/mcL
  • Hemoglobin ≥ 8 g/dL
  • Total serum bilirubin normal
  • AST and ALT ≤ 2.5 x upper limit of normal
  • Creatinine < 2.5 mg/dL
  • Negative pregnancy test for women of childbearing potential

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 (e.g., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row) or QTc prolongation (e.g., QTc interval ≥ 500 msec)
  • Poorly controlled hypertension (e.g., systolic BP ≥ 140 mm Hg OR diastolic BP ≥ 90 mm Hg)
  • Any condition that impairs the ability to swallow and retain sunitinib malate tablets (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease)
  • Any other condition, including the following:

    • Serious or nonhealing wound, ulcer, or bone fracture
    • History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within the past 28 days
    • History of cerebrovascular accident (CVA) or transient ischemic attack within the past 12 months
    • History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within the past 12 months
    • History of pulmonary embolism within the past 12 months
    • NYHA class III or IV heart failure

      • Patients with NYHA class II heart failure on baseline ECHO or MUGA are eligible provided they are asymptomatic on treatment
  • 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

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

  • 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 NYHA class II or better cardiac function on baseline ECHO or MUGA
  • Concurrent bisphosphonates allowed

Exclusion criteria:

  • 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 (i.e., thalidomide or high-dose corticosteroids) ≤ 2 weeks prior to study entry
  • At least 7 days since prior and no concurrent CYP3A4 inhibitors, including the following:

    • Azole antifungals (ketoconazole, itraconazole)
    • Verapamil
    • Clarithromycin
    • HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir)
    • Erythromycin
    • Delavirdine
    • Diltiazem
  • At least 12 days since prior and no concurrent CYP3A4 inducers, including the following:

    • Rifampin
    • Phenytoin
    • Rifabutin
    • Hypericum perforatum (St. John's wort)
    • Carbamazepine
    • Efavirenz
    • Phenobarbital
    • Tipranavir
  • Any other prior antiangiogenic agents (e.g., bevacizumab, sorafenib, pazopanib, cediranib, vatalanib, or aflibercept)
  • Concurrent high-dose corticosteroids

    • Concurrent chronic steroids (up to 20 mg/day prednisone equivalent) allowed for disorders other than amyloid (i.e., adrenal insufficiency or rheumatoid arthritis)
  • Concurrent therapeutic doses of coumarin-derivative anticoagulants (e.g., warfarin)

    • Up to 2 mg/day of coumarin-derivative anticoagulants allowed for prophylaxis of thrombosis
    • Low molecular weight heparin allowed provided PT INR ≤ 1.5
  • Concurrent agents with proarrhythmic potential (e.g., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, or flecainide)
  • Concurrent combination antiretroviral therapy for HIV-positive patients
  • Any other concurrent investigational agents or anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514137

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, District of Columbia
Howard University Cancer Center
Washington, District of Columbia, United States, 20060
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Minnesota Oncology Hematology, PA - Minneapolis
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Center for Cancer Care and Research
Saint Louis, Missouri, United States, 63141
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
China
Prince of Wales Hospital
Hong Kong, China
Singapore
Cancer Institute at National University Hospital
Singapore, Singapore, 119074
Johns Hopkins Singapore International Medical Centre
Singapore, Singapore, 308433
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Shaji K. Kumar, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Mayo Clinic Cancer Center ( Charles Erlichman )
Study ID Numbers: CDR0000560703, MCCRC-MC058F
Study First Received: August 8, 2007
Last Updated: April 18, 2009
ClinicalTrials.gov Identifier: NCT00514137     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Study placed in the following topic categories:
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Angiogenesis Inhibitors
Multiple Myeloma
Hemorrhagic Disorders
Sunitinib
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Blood Protein Disorders
Hematologic Diseases
Growth Substances
Physiological Effects of Drugs
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Angiogenesis Inhibitors
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Sunitinib
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 07, 2009