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


Phase 2
18 Years
N/A
Not Enrolling
Both
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


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 ConsortiumRochester, Minnesota  55905