Multiple Myeloma Clinical Trial

Sunitinib in Treating Patients With Relapsed Multiple Myeloma

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

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Full Description

PRIMARY OBJECTIVES:

I. To assess the number of responses in patients with relapsed multiple myeloma treated with sunitinib (sunitinib malate).

SECONDARY OBJECTIVES:

I. To assess the toxicity of sunitinib malate in patients with relapsed multiple myeloma.

II. To assess time to progression after initial response to sunitinib malate.

OUTLINE:

Patients receive oral sunitinib malate 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.

View Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

13

Study ID:

NCT00514137

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There is 1 Location for this study

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Mayo Clinic Cancer Research Consortium
Rochester Minnesota, 55905, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

13

Study ID:

NCT00514137

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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