Sunitinib in Treating Patients With Relapsed Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00514137
Recruitment Status : Completed
First Posted : August 9, 2007
Results First Posted : March 6, 2013
Last Update Posted : May 28, 2014
Information provided by (Responsible Party):
National Cancer Institute (NCI)

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

Condition or disease Intervention/treatment Phase
Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma Drug: sunitinib malate Phase 2

Detailed Description:


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 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma
Study Start Date : September 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : August 2010

Arm Intervention/treatment
Experimental: 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.
Drug: sunitinib malate
Oral 37.5 mg each day of the 6-week cycle (continuous dosing).
Other Names:
  • SU11248
  • sunitinib
  • Sutent

Primary Outcome Measures :
  1. The Number of Confirmed Responses (Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR]) [ Time Frame: Every 6 weeks from the first initiation of therapy up to 72 weeks ]

    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.

Secondary Outcome Measures :
  1. Event-free Survival [ Time Frame: Time from registration to progression or death due to any cause, assessed up to 3 years ]
    The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.

  2. Duration of Response [ Time Frame: From the documentation of response until the date of progression ]
    The distribution of duration of response will be estimated using the method of Kaplan-Meier.

  3. Toxicity [ Time Frame: From the time of first treatment to up to 30 days after the last day of study drug treatment ]
    Assessed per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Included are the toxicities at least possibly related to the study drug.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00514137

United States, Minnesota
Mayo Clinic Cancer Research Consortium
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Shaji Kumar Mayo Clinic

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00514137     History of Changes
Other Study ID Numbers: NCI-2009-00208
CDR0000560703 ( Registry Identifier: PDQ (Physician Data Query) )
N01CM62205 ( U.S. NIH Grant/Contract )
First Posted: August 9, 2007    Key Record Dates
Results First Posted: March 6, 2013
Last Update Posted: May 28, 2014
Last Verified: March 2013

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors