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A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

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Trial Information

A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma


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


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.


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

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

- 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

- 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

- 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:


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:


Principal Investigator

Shaji Kumar

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




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



Mayo Clinic Cancer Research ConsortiumRochester, Minnesota  55905