A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma
18 Years
N/A
Both
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma
Trial Information
A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The Number of Confirmed Responses (Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR])
Outcome Description:
A confirmed response is defined as a patient who has achieved response and maintained it on two consecutive evaluations at least 2 weeks apart. A Complete Response (CR) is defined as the complete disappearance of an M-protein and fewer than 5% bone marrow plasmacytosis. A Hematologic Very good partial response (VGPR) is defined as having a ≥ 90% reduction of M-protein from serum, a Urine M-spike to be ≤ 100 mg/24 hours, and a disappearance of soft tissue plasmacytomas. A Partial Response (PR) is defined as having a 50-89% reduction in the level of the serum monoclonal protein, a reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg, and a ≥ 50% reduction in size of soft tissue plasmacytoma.
Outcome Time Frame:
Every 6 weeks from the first initiation of therapy up to 72 weeks
Safety Issue:
No
Principal Investigator
Shaji Kumar
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2009-00208
NCT ID:
NCT00514137
Start Date:
September 2007
Completion Date:
April 2009
Related Keywords:
- Refractory Multiple Myeloma
- Stage I Multiple Myeloma
- Stage II Multiple Myeloma
- Stage III Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Mayo Clinic Cancer Research Consortium | Rochester, Minnesota 55905 |
