Sunitinib in Treating Patients With Relapsed Multiple Myeloma

NCT ID: NCT00514137

Last Updated: 2014-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-08-31

Brief 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

Detailed 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.

Conditions

Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (kinase inhibitor therapy)

Patients receive 37.5 mg 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.

Group Type: EXPERIMENTAL

sunitinib malate

Intervention Type: DRUG

Oral 37.5 mg each day of the 6-week cycle (continuous dosing).

Interventions

sunitinib malate

Oral 37.5 mg each day of the 6-week cycle (continuous dosing).

Intervention Type: DRUG

Other Intervention Names

SU11248; sunitinib; Sutent

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shaji Kumar

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Cancer Research Consortium

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

MC058F

Identifier Type: -

Identifier Source: secondary_id

CDR0000560703

Identifier Type: REGISTRY

Identifier Source: secondary_id

N01CM62205

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00208

Identifier Type: -

Identifier Source: org_study_id