Sunitinib in Treating Patients With Relapsed Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00514137
First received: August 8, 2007
Last updated: March 22, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Refractory Multiple Myeloma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Drug: sunitinib malate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • Event-free Survival [ Time Frame: Time from registration to progression or death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]
    The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.

  • Duration of Response [ Time Frame: From the documentation of response until the date of progression ] [ Designated as safety issue: No ]
    The distribution of duration of response will be estimated using the method of Kaplan-Meier.

  • Toxicity [ Time Frame: From the time of first treatment to up to 30 days after the last day of study drug treatment ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 13
Study Start Date: September 2007
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514137

Locations
United States, Minnesota
Mayo Clinic Cancer Research Consortium
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Investigators
Principal Investigator: Shaji Kumar Mayo Clinic
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00514137     History of Changes
Other Study ID Numbers: NCI-2009-00208, MC058F, CDR0000560703, N01CM62205
Study First Received: August 8, 2007
Results First Received: January 30, 2013
Last Updated: March 22, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014