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Sunitinib in Treating Patients With Relapsed Multiple Myeloma

Primary Purpose

Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sunitinib malate
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Cancer Research Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (kinase inhibitor therapy)

Arm Description

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.

Outcomes

Primary Outcome Measures

The Number of Confirmed Responses (Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR])
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
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
Duration of Response
The distribution of duration of response will be estimated using the method of Kaplan-Meier.
Toxicity
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.

Full Information

First Posted
August 8, 2007
Last Updated
May 12, 2014
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00514137
Brief Title
Sunitinib in Treating Patients With Relapsed Multiple Myeloma
Official Title
A Phase II Trial of Sunitinib (SU11248) in Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (kinase inhibitor therapy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Other Intervention Name(s)
SU11248, sunitinib, Sutent
Intervention Description
Oral 37.5 mg each day of the 6-week cycle (continuous dosing).
Primary Outcome Measure Information:
Title
The Number of Confirmed Responses (Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR])
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.
Time Frame
Every 6 weeks from the first initiation of therapy up to 72 weeks
Secondary Outcome Measure Information:
Title
Event-free Survival
Description
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
Time Frame
Time from registration to progression or death due to any cause, assessed up to 3 years
Title
Duration of Response
Description
The distribution of duration of response will be estimated using the method of Kaplan-Meier.
Time Frame
From the documentation of response until the date of progression
Title
Toxicity
Description
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.
Time Frame
From the time of first treatment to up to 30 days after the last day of study drug treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaji Kumar
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Cancer Research Consortium
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Sunitinib in Treating Patients With Relapsed Multiple Myeloma

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